PTSD Treatment for Incarcerated Men and Women: NIMH
Phase: NA
Conditions: PTSD
Sponsor: University of Wisconsin, Madison

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
 
 
 
 
 
 
 
 
 
PTSD Treatment for Incarcerated Men and Women: NIMH  
NCT05168267  
Approval Date: 01/22/2025

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
 
Title: PTSD treatment for incarcerated men and women 
 
PI Name: Michael Koenigs, PhD 
 
PI affiliation: Department of Psychiatry, University of Wisconsin-Madison 
 
POC: Odile Rodrik, Mickela Heilicher (UW-Madison PhD students), Madilyn Michels (Research 
Specialist) 
 
Protocol version/date: Approved 01/22/2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
 
Background and Significance 
Prisons and jails are the de facto largest providers of mental health services in the U.S. Mental 
illness is epidemic within the U.S. jail and prison population. It is estimated that over half of the 
2.3 million people incarcerated in this country have experienced symptoms of mental illness within 
the past year[2]. The failure to effectively treat mental illness in incarcerated individuals is 
associated with a host of dire outcomes. Mental illness among incarcerated people is associated 
with higher rates of suicide; higher rates of victimization for rape and other forms of abuse; higher 
rates of rules infractions and solitary confinement; higher rates of violence; higher rates of 
substance abuse; and higher rates of recidivism and re-arrest after release [2]. Improving 
psychiatric care would thus yield substantial societal benefit in terms of reduced costs to the 
criminal justice system and increased public safety. 
 
There is a particular need for more effective treatments for post-traumatic stress disorder (PTSD) 
within the incarcerated population. The prevalence of trauma history and PTSD are markedly 
higher in jail and prison populations than in the general population, with estimates of current PTSD 
prevalence among incarcerated individuals exceeding 20% [3,4], as opposed to 3-6% in the general 
population [5–7]. The prevalence of PTSD among incarcerated populations is at least as high as 
that of military veterans [8]. PTSD is also associated with an increased risk for crime-related 
behaviors, such as violence [9–11] and substance abuse [12,13]. There is virtually no research 
examining the efficacy of empirically supported therapies for PTSD in incarcerated individuals. 
Despite the patent need for more effective treatment strategies, there is scant translational research 
on PTSD in this population [14,15], and no randomized controlled studies that have tested the 
efficacy of empirically supported PTSD treatments in the prison setting. The treatment programs 
offered to people in prison (across the United States, but particularly in Wisconsin) target specific, 
overt criminal behaviors (e.g., alcohol/drug use, violence, sexual offenses), rather than underlying 
psychopathology. Our program of research could usher a new paradigm of rehabilitation, by 
addressing the traumatic experiences and consequent psychopathology that predispose individuals 
to certain forms of maladaptive and criminal behavior. 
 
Cognitive Processing Therapy (CPT) is a potentially promising PTSD treatment for the prison 
setting, primarily due to its cost- and time-effectiveness in the manualized group format. Individual 
(one-on-one) therapies such as Prolonged Exposure and Eye Movement Desensitization and 
Reprocessing are less likely to gain widespread implementation in prison systems, where therapist 
access is a major limitation. In addition, CPT is applicable to a wide range of individuals, such as 
those with minimal formal education, low IQs, or comorbid psychiatric disorders [16] . In studies 
of non-incarcerated individuals, CPT has been found to be more effective than wait-list control 
and equivalent to Prolonged Exposure [17–19]. The majority of non-incarcerated individuals 
undergoing CPT for PTSD exhibit a clinically significant reduction in symptoms, with over 40% 
achieving a loss of the diagnosis [20]. However, the generalizability of these findings to the 
offender population has not yet been determined. Our research study will determine whether CPT 
is indeed an effective and feasible treatment for PTSD in incarcerated people or whether different 
treatment strategies need to be developed.  
 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
This project capitalizes on an extraordinary long-term collaboration between the University of 
Wisconsin-Madison and the State of Wisconsin Department of Corrections (DOC). Having 
facilitated University of Wisconsin-Madison investigators’ basic research in forensic psychology 
for over 30 years, the DOC is eager to facilitate the translation to more effective therapies for 
people in prison. Prisons are an excellent environment for PTSD research because the percentage 
of prisoners with PTSD is extremely high, the need for treatment is easily justified, and the affected 
individuals are regularly available and willing to participate. The DOC has enabled our research 
team to collect data for our ongoing research projects with remarkable efficiency. Over the last 8 
years, we have enrolled over 2,800 people incarcerated in the Wisconsin DOC into our research 
studies. Each of these individuals has participated in an in-person interview assessment with our 
research staff. We thus clearly have a one-of-a-kind research environment and a unique 
opportunity to advance research on PTSD in prison. 
 
This study will be split into two branches: the NIMH branch, which corresponds to an R34 grant 
and the WPP branch, which corresponds to a grant from the Wisconsin Partnership Program. The 
two branches will follow similar protocols with minor differences in study objectives, research 
design, participant numbers, and assessments (described below). The NIMH branch will be 
implemented first. Once the NIMH branch has been completed at a specific facility, the WPP 
branch can be implemented at that facility.  
 
Overall Study Objectives: 
The branches of this study have both overlapping and complementary, unique primary objectives. 
 
NIMH Branch: 
1. Establish the feasibility of group CPT delivery in male and female incarcerated populations 
with PTSD. 
2. Establish the acceptability of group CPT in male and female incarcerated populations with 
PTSD. 
3. Establish feasibility of assessment collection for primary outcome measures, secondary 
outcome measures, and potential mediators and moderators during a clinical trial 
examining group CPT delivery in incarcerated settings. 
 
WPP Branch: 
1. Determine the effectiveness of group CPT in reducing PTSD symptom severity in male 
and female incarcerated populations.  
2. Identify putative psychological mechanisms of response to CPT through pre-, mid-, and 
post-intervention measures of PTSD severity as well as measures of hopelessness, self-
blame, and negative self-related thoughts. 
 
Hypotheses: 
 
NIMH Branch: 
1. It is predicted that feasibility will be established by obtaining ≥80% participant retention 
for the CPT course. As additional metrics of feasibility we will assess eligibility; 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
participation; compliance; adherence; competence; and safety.  
2. It is predicted that group CPT acceptability will be established by obtaining mean scores ≥ 
27 on the CSQ-8.  
3. It is predicted that assessment collection feasibility will be established by obtaining 100% 
of PCL-5s at each timepoint for participants retained at that timepoint.  
 
WPP Branch: 
1. It is predicted that compared to the active control group, the CPT group will exhibit 
significantly greater reductions in PTSD symptom severity (primary outcome measure) as 
well as reductions in the severity of depression and general anxiety symptoms (secondary 
outcome measures) over the course of treatment.  
2. It is predicted that the CPT group will exhibit greater reductions in hopelessness, self-
blame, and negative self-related thoughts compared to the active control group.  
a. Within only the CPT group, the reductions in hopelessness, self-blame, and 
negative self-related thoughts will precede the reduction in PTSD symptoms. 
b. Within only the CPT group, the reduction in PTSD symptom severity will be 
mediated by reductions in hopelessness, self-blame, and negative self-related 
thoughts. 
 
 
Trainee Project:  
This study is part of the dissertation project of Odile Rodrik.  
 
Participants: 
Participants will be adult male and female individuals incarcerated in Wisconsin state prisons. 
Males will be recruited from Oakhill Correctional Institution (OCI), a minimum-security 
Wisconsin DOC facility housing over 600 adult males and Fox Lake Correctional Institution 
(FLCI), a medium-security Wisconsin DOC facility housing over 1,300 adult males. Females will 
be recruited from Taycheedah Correctional Institution (TCI), a mixed-security Wisconsin DOC 
facility housing over 800 adult females.  
 
Participants will be withdrawn from the study if they exhibit disruptive behavior (e.g., verbal or 
physical abuse towards another participant or therapist, repeatedly do not respect group rules 
outlined at the beginning of treatment) any time throughout participation. Prior to beginning any 
study procedures, informed consent will be obtained orally and in writing. During the informed 
consent process, eligible participants will be provided with detailed information about the study, 
including their right to refuse or discontinue participation at any time and the fact that their 
decision to participate or decline will have no bearing on their standing within the criminal 
justice system.  
 
 
 
 
 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
Eligibility Criteria:  
Inclusion Criteria:  
NIMH Branch: 
Participants will be eligible to participate if they meet the following criteria: 18 years of age or 
older; IQ greater than or equal to 70; reading level of 4th grade or higher; no active symptoms of 
psychosis that would interfere with the individuals ability to participate in the group, no active 
suicidal ideation with intent or plan, able and willing to participate in group therapy; no scheduled 
release date before the end of the treatment group; and not currently enrolled in trauma focused 
treatment that is historical or involves processing of trauma itself. Other vulnerable populations 
within the prison setting (i.e., pregnant women or individuals appearing to lack the capacity to 
provide informed consent) will not be eligible for participation.  Research suggests that a PCL-5 
score between 31-33 indicates a probable diagnosis of PTSD. Accordingly, participants will be 
eligible to participate if they score a 31 or greater on the PCL-5 within two months of starting the 
study treatment. We will identify participants meeting these eligibility criteria from the pool of 
subjects who have previously participated in another IRB-approved protocol led by PI Dr. Michael 
Koenigs (2014-1106). 
 
 
WPP Branch: 
Taycheedah Correctional Institution:  
Participants will be eligible to participate if they meet the following criteria: 18 years of age or 
older; no serious self-harm past 6-months (in clinical observation due to self-harm), no 
disciplinary segregation time in past 6-months, have not participated in the previous CPT groups 
with UW Project (NIMH branch), no active symptoms of psychosis that would interfere with the 
individual's ability to participate in the group, no active suicidal ideation with intent or plan, able 
and willing to participate in group therapy; not currently enrolled in trauma focused treatment 
that is historical or involves processing of trauma itself; no scheduled release date before the end 
of the treatment group; and able to understand the consent form as measured by the consent quiz. 
Research suggests that a PCL-5 score between 31-33 indicates a probable diagnosis of PTSD. 
Accordingly, participants will be eligible to participate if they score a 31 or greater on the PCL-5 
within two months of starting the study treatment. We will identify participants meeting these 
eligibility criteria from the DOC list of residents on the waitlist for trauma treatment.  
 
Kettle Moraine Correctional Institution: 
Participants will be eligible to participate if they meet the following criteria: 18 years of age or 
older, no disciplinary placement (RHU) within the last 30 days; no active symptoms of psychosis 
that would interfere with the individual's ability to participate in the group, no active suicidal 
ideation with intent or plan, able and willing to participate in group therapy; not currently 
enrolled in trauma focused treatment that is historical or involves processing of trauma itself; no 
scheduled release date before the end of the treatment group; and able to understand the consent 
form as measured by the consent quiz. Research suggests that a PCL-5 score between 31-33 
indicates a probable diagnosis of PTSD. Accordingly, participants will be eligible to participate 
if they score a 31 or greater on the PCL-5 within two months of starting the study treatment. We 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
will identify participants meeting these eligibility criteria from the DOC list of residents on the 
waitlist for trauma treatment. 
 
Exclusion Criteria:  
NIMH Branch: 
Participants will be eligible to participate if they meet the following criteria: 18 years of age or 
older; IQ greater than or equal to 70; reading level of 4th grade or higher; active symptoms of 
psychosis that would interfere with the individuals ability to participate in the group, active 
suicidal ideation with intent or plan, not able and willing to participate in group therapy; scheduled 
release date before the end of the treatment group; and currently enrolled in trauma focused 
treatment that is historical or involves processing of trauma itself. Other vulnerable populations 
within the prison setting (i.e., pregnant women or individuals appearing to lack the capacity to 
provide informed consent) will not be eligible for participation. Research suggests that a PCL-5 
score between 31-33 indicates a probable diagnosis of PTSD. Accordingly, participants will be 
eligible to participate if they score a 31 or greater on the PCL-5 within two months of starting the 
study treatment.  
 
WPP Branch: 
Taycheedah Correctional Institution:  
Participants will be eligible to participate if they meet the following criteria: 18 years of age or 
older; no serious self-harm past 6-months (in clinical observation due to self-harm), no 
disciplinary segregation time in past 6-months, have not participated in the previous CPT groups 
with UW Project (NIMH branch), no active symptoms of psychosis that would interfere with the 
individual's ability to participate in the group, no active suicidal ideation with intent or plan, able 
and willing to participate in group therapy; not currently enrolled in trauma focused treatment that 
is historical or involves processing of trauma itself; no scheduled release date before the end of the 
treatment group; and able to understand the consent form as measured by the consent quiz. 
Research suggests that a PCL-5 score between 31-33 indicates a probable diagnosis of PTSD. 
Accordingly, participants will be eligible to participate if they score a 31 or greater on the PCL-5 
within two months of starting the study treatment.  
 
Kettle Moraine Correctional Institution:  
Participants will be eligible to participate if they meet the following criteria: 18 years of age or 
older, no disciplinary placement (RHU) within the last 30 days; no active symptoms of psychosis 
that would interfere with the individual's ability to participate in the group, no active suicidal 
ideation with intent or plan, able and willing to participate in group therapy; not currently 
enrolled in trauma focused treatment that is historical or involves processing of trauma itself; no 
scheduled release date before the end of the treatment group; and able to understand the consent 
form as measured by the consent quiz. Research suggests that a PCL-5 score between 31-33 
indicates a probable diagnosis of PTSD. Accordingly, participants will be eligible to participate 
if they score a 31 or greater on the PCL-5 within two months of starting the study treatment. We 
will identify participants meeting these eligibility criteria from the DOC list of residents on the 
waitlist for trauma treatment. 
 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
 
ALL WPP BRANCH:  
Participants will also be told the specific limits to confidentiality. Participants will also be told 
the limits to confidentiality for research staff and DOC therapists, specifically. Research staff 
will have to report, if participants share an intention to harm themselves or others, disclose plans 
to escape or start a riot, or disclose any sexual activity between residents or residents and staff.  
 
DOC therapists will follow the Limits of Confidentiality of Health Information outlined by the 
DOC, which are as follows:  
Health care providers must report otherwise confidential information to the appropriate DOC 
authorities if it raises concern about a threat to you, a DAI or DJC correctional facility, 
community corrections operations, and/or public safety. This may include the following: 
a. Overt/covert threats or harm to yourself or others. 
b. Reports of any alleged sexual activity between an offender and any other person. 
c. Reports of any sexual assault or intimidation between an offender and any other person. 
d. Plans to riot or escape and possession of drugs or weapons. 
e. Suspicious or unexplained deaths (homicides, suicides). 
f. Unknown past criminal conduct that increases the potential risk to a correctional facility, 
community corrections operations, and/or the public, including self-reported acts of homicide, 
attempted homicide, and first or second-degree sexual assault. 
 
Zoom Information:  
While initial participant consent will be in-person, including signed, written consent, we will 
conduct verbal reconsent to address any minor changes to the consent form. This will include 
oral reconsent of participants associated with CP008, where participants will be provided with 
detailed information regarding the possibility of Zoom visits and changes in compensation and 
provide verbal reconsent to participate. Specifically, research staff will explain that some of the 
assessments may take place on Zoom for the remainder of their participation, and some 
assessments may take place in person. We will explain that the assessments will remain the 
same, and the only difference will be that they could take place over Zoom instead of in person. 
Then, participants will be given a chance to ask any questions about the changes and will be 
asked by study staff if they are comfortable doing virtual assessments. If they confirm that they 
are comfortable doing study visits over Zoom, we will continue with the assessment. We will 
track which assessments are conducted via Zoom and which are conducted in-person. If they are 
not comfortable doing study visits over Zoom, we will track this response and only conduct 
future study visits in person. NIMH branch participants have already consented to participate in 
Zoom visits for protocol 2014-1106. A waiver of signed reconsent is being requested for the 
reconsent plan under 45 CFR 46.117(c)(2) due to the fact that the changes in consent which we 
will communicate verbally and request verbal reconsent for present no more than minimal risk of 
harm to subjects and involve no procedures for which written consent is normally required 
outside of the research context. 
 
 
 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
WPP Branch Only: 
Participants will be reconsented using the updated consent form from the CP021 change, which 
informs them about the collection of RHU placements, conduct reports, clinical observations, 
reconviction, and re-incarceration through public records and/or requests from the Department of 
Corrections database. We will try to schedule two meetings for participants still housed at TCI to 
minimize the burden on facility staff. Facility staff will send a movement slip for them to meet 
with the UW project, and if they don’t show up, we will call them down using the phone with a 
CO present. The re-consent process will only occur in person, as video calls would place an 
additional burden on facility staff and require more resources.  
 
In the single branch version of this protocol prior to CP006, we enrolled 70 participants since that 
enrollment our protocol was revised, since then this is now a two-branch study. Our target 
enrollment thus includes the prior 70 participants from the prior protocol.  
 
For the current two branch protocol, up to a total of 172 incarcerated individuals (76 male and 76 
female) will participate in group assignment. To account for potential participant attrition between 
consent and group assignment (e.g., due to transfer, release, segregation) we will enroll a total of 
up to 270 participants (taking into account single-component version enrolled participants) based 
on eligibility from participation in protocol 2014-1106. Over the course of the study, we will run 
twelve rounds of CPT sessions; these rounds will include 12 CPT sessions occurring twice a week 
for a total of 6 weeks. Six of these rounds will be conducted at TCI, and Six will be conducted 
across OCI and FLCI. In addition, WPP branch of the study involves a waitlist control group; this 
group will receive the CPT treatment after the treatment group completes the treatment. 
Participation in the waitlist control group will not affect participation in any other treatments that 
are available at the facilities. . Sessions will be conducted at TCI and across OCI or FLCI. 
 
 
Vulnerable Populations: 
This study will enroll incarcerated individuals because rates of trauma exposure and PTSD are 
much higher in the prison population than the general population. Moreover, the focus of the 
current study is to examine the efficacy of providing empirically supported PTSD treatment in a 
correctional setting. Recruiting incarcerated individuals provides an opportunity to better 
understand if “best practice” mental health services in the community are feasible and 
efficacious in a prison setting. To further minimize risks for prisoners we will adhere to the 
requirements listed under section 45 CFR 46.303(d) of the Department of Health and Human 
Safety, minimal risk for incarcerated individuals. In addition, the following guidelines will be 
followed: 
 
(1) The research under review represents one of the categories of research permissible under 45 
CFR 46.306(a)(2). Protections: The research proposed within the present application falls within 
sections (i) and (iii) of this mandate. Regarding criterion (i), this study is designed to identify 
psychological and affective factors that may predispose a person to criminal behavior and 
incarceration in order to effectively design and implement treatment programs. Specifically, 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
PTSD severity has been linked to increased risk of recidivism, and trauma is a hypothesized 
precursor to criminality [2,3,10]. 
 
(2) Any possible advantages accruing to the incarcerated individuals through his or her 
participation in the research, when compared to the general living conditions, medical care, 
quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude 
that his or her ability to weigh the risks of the research against the value of such advantages in 
the limited choice environment of the prison is impaired. Protections: Incarcerated individuals 
will be paid $5.00/hr for their participation in the proposed work. This level of incentive would 
allow inmates to purchase items of modest value (e.g., snacks, hygiene products) from the prison 
canteen. 
  
(3) The risks involved in the research are commensurate with risks that would be accepted by 
non-incarcerated volunteers. Protections: The psychological assessments and interventions 
undertaken entail only minimal risk for incarcerated individual and non-incarcerated populations, 
alike. We thus anticipate the creation of only minimal risk from these procedures, similar to 
those that would be encountered in non-incarcerated populations.  
  
(4) Procedures for the selection of subjects within the prison are fair to all incarcerated 
individuals and immune from arbitrary intervention by prison authorities or incarcerated 
individuals. Protections: Subject exclusions are decided solely by the study team, and only 
according to the exclusion criteria designed for participant safety and experimental validity. 
  
(5) The information is presented in language which is understandable to the subject population. 
Protections: All consent material will be provided in both written and oral format. All written 
consent material has been written so as to be readable to an individual with a 5th grade reading 
level. These consent materials have been used by Dr. Koenigs for the past nine years of prisoner 
research, and are well-received by prisoners with limited reading skills. For the NIMH branch, a 
reading test is provided to screen for low reading ability. Participants displaying reading skills 
below a grade 5 reading level, or with an IQ below 80, will be excluded from participation in the 
NIMH branch. For the WPP branch, we will utilize the Consent Quiz as a measure of intellectual 
ability and reading level. Thus, we can be sure that all participating incarcerated individuals will 
show sufficient reading skills to make informed decisions throughout the study procedures. Items 
on some questionnaire measures may include certain words above this reading level. 
Incarcerated individuals will be encouraged to ask the trained research assistants for definitions 
of any words that they do not understand. 
  
(6) Adequate assurance exists that parole boards will not take into account a prisoner's 
participation in the research in making decisions regarding parole, and each incarcerated 
individual is clearly informed in advance that participation in the research will have no effect on 
his parole. Protections: Incarcerated individuals will be informed, both orally and in writing, 
during the initial consenting procedure, that their decision about whether or not to participate in 
this study will have no bearing on their status within the correctional system, and that any 
information collected within this study will not be included in their prison records. Incarcerated 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
individuals will be informed that the researchers have no direct affiliation with the Wisconsin 
DOC. Finally, incarcerated individuals will be informed that all of the identifiable data collected 
within the study will be stored within a locked cabinet or on a secure password-protected server 
within our laboratory, and nowhere else. Prison officials will have no access to the data collected 
in the study, and no information will be used to influence prisoner’s treatment in prison. From 
the time of inclusion within the study, only unique numerical identifiers will be used on all study 
material. All identifying information will be stored in locked filing cabinets or on secure servers 
in locked offices within the PI’s laboratory. 
  
(7) Where the IRB finds that there may be need for follow-up examination or care of participants 
after the end of their participation, adequate provision has been made for such examination or 
care, taking into account the varying lengths of individual incarcerated individuals' sentences, 
and for informing participants of this fact. At least one member of the IRB must be an 
incarcerated individual, or a prisoner representative with appropriate background and experience 
to serve in that capacity, except that where a particular research project is reviewed by more than 
one IRB, only one IRB need satisfy this requirement. Protections: As has been standard at the 
University of Wisconsin-Madison, the IRB will include at least one prisoner representative when 
evaluating this research protocol. We do not anticipate need for follow-up examinations, as there 
should be no long-term health risks of any of the procedures performed within the study. 
Incarcerated individuals will, however, be provided with the PI’s work phone number and 
mailing address, and will be encouraged to contacting the PI if they have any questions or 
concerns, or experience any effects of study participation. 
 
WPP Branch 
This study might enroll individuals with intellectual disabilities (e.g., low reading level) because 
we are basing our eligibility criteria off the DOC’s eligibility requirements for participation in 
treatment. The DOC does not limit eligibility based on intellectual ability. Participation in this 
study presents minimal risk to individuals with intellectual disabilities. With respect to the 
possibility of including participants with significant intellectual disabilities and/or low reading 
level, we will utilize the consent quiz to assess for ability to provide informed consent. The 
consent quiz is based on the U-ARE protocol for decisional capacity assessment for clinical 
research53, and is more extensive in the questions asked. 
 
This study might enroll pregnant persons because we are basing our eligibility criteria off the 
DOC’s eligibility requirements for participation in treatment. The DOC does not limit eligibility 
based on pregnancy status. Participation in this study presents minimal risk to individuals who 
may be pregnant. In order to further limit any risk, we will not be collecting information about 
pregnancy; therefore, pregnancy status will not be identified or recorded. 
 
 

PTSD treatment for Incarcerated Individuals 
CP021 – Approval Date: 01/22/2025 
Koenigs 
 
† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
  
NIMH Branch: 
 
In this branch, we will run CPT sessions that will take place over 6 to 12 weeks depending on 
session frequency within the female prison (TCI) and across male prisons (OCI and FLCI) within 
two years. A total of 72 incarcerated individuals (36 male and 36 female) will participate.  
 
WPP Branch: 
 
In this branch, we will run CPT sessions that will take place over 6 or 12-week, and obtain data 
from a waitlist control group within the female prison (TCI) and across male prisons (FLCI or 
OCI) within three years. A total of 80 participants (40 male and 60 female) will participate in group 
randomization 
 
Research Design and Procedures: 
Potential participants will be contacted by either calling them over the phone system within the 
prison or scheduling a time to meet with them about the study through individual prison scheduling 
systems. When they arrive to the private testing room, they are asked if they would like to learn 
about the study and potentially participate. If so, we begin the consent process. Eligible participants 
will complete the PCL-5 to ascertain current PTSD symptomology and probable diagnosis. Study 
consent and initial assessments will be conducted by trained graduate students, study staff, and/or 
advanced undergraduates with extensive experience working on our prison project. Midpoint, post-
treatment, and follow-up interview sessions may take place over Zoom or in person. All focus 
groups will be conducted in person. If at any point a participant withdraws from the study, they 
will no longer be contacted for participation. 
 
  
NIMH Branch: 
Participants will be assigned to a CPT group if they meet PCL-5 criteria for a current probable 
PTSD diagnosis. CPT groups will engage in 12, 90-minute treatment sessions (18 hours total). 
With the optional opportunity to take 15-20 minutes after each session to de-stress and calm down 
if necessary.  These sessions will take place over 6 to 12 weeks, depending on session frequency. 
The CPT group-members are also asked to complete weekly homework (approximately 12 hours 
total) as well as a post-intervention focus group and will have one follow up CPT session 6-8 
weeks post-treatment. A maximum of 8 participants, but no less than 3 will be included in each 
CPT group. Participants will be able to continue any ongoing treatment/interventions they are 
engaged in within the institution as long as it meets our eligibility requirements.   
 
In addition to the treatment groups, CPT group members will also complete a number of additional 
testing sessions throughout the course of treatment. They will participate in a pre-treatment testing 
session two weeks prior to the start of treatment. They will be asked to complete the PCL-5 at the 
beginning of each treatment session. After treatment session 5, group members will complete mid-
treatment testing assessments. Participants will be called down individually to complete these 
assessments in a private room with a research assistant after completing the 5th therapy session, 

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† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
but before completing the 8th therapy session. Group members will then complete post-treatment 
testing within one week after completing treatment (group session 12). One month after the 
treatment is completed, group members will complete the first round of follow-up testing. Three 
months after the treatment is completed, group members will complete the final round of follow-
up testing. Post-one-month, and three-month follow up-testing will follow the same procedure as 
pre- and mid-testing. In total, group members will be asked to complete 18 sessions in total (pre-, 
mid-, post-, one-month follow up-testing, three-month follow-up testing, 12 treatment groups, and 
1 post-intervention focus group). 
 
WPP Branch: 
Participants will be randomly assigned to the CPT or the active control groups (randomization 
process specified in “Randomization and Blinding”). The CPT group will engage in 12, 90-minute 
treatment sessions (18 hours total). With the optional opportunity to take 15-20 minutes after each 
session to de-stress and calm down if necessary. These sessions will take place over 6 to 12 weeks, 
depending on session frequency. CPT group-members are also asked to complete weekly 
homework (approximately 12 hours total). A maximum of 8 participants, but no less than 3 will 
be included in each CPT group. When the waitlist control group reaches the treatment phase, if the 
participant count fall below 3, additional participants will be enrolled to maintain sufficient 
numbers. Data collection during treatment will mirror that of the active waitlist control group. 
Participants will be notified via institutional mail which group they have been enrolled in. 
 
In addition to the treatment groups, CPT and control group members will complete a PCL-5 at the 
beginning of each session. As well as, pre-treatment testing session two weeks prior to the start of 
treatment. After treatment session 5, CPT and control group members will complete mid-treatment 
testing assessments. Participants will be called down individually to complete these assessments 
in a private room with a research assistant after completing the 5th therapy session, but before 
completing the 8th therapy session. CPT and control group members will then complete post-
treatment testing within one week after completing week 6 of treatment. One month after the 
treatment is completed, CPT and control group members will complete follow-up testing and 
interviewing about their experience in the treatment groups and will have one follow up CPT 
session 6-8 weeks post-treatment. Post-treatment and one-month follow up- testing will follow the 
same procedure as pre-treatment and mid-treatment testing. Final follow-up will occur three 
months after the end of treatment. Procedures will be the same as other timepoint follow-ups. CPT 
and control group members will be asked to complete 18 sessions in total (pre-treatment, mid- 
treatment, post- treatment, one-month follow up-testing, three-month follow-up treatment, 12 
group sessions and one follow-up CPT session).  
 
 

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† For the NIMH branch,  any historical data (i.e., information that is stable and is not expected to change over 
time) that has already been collected through protocol 2014-1106, we will obtain this data from the PI's 
database (2014-0350) and will not re-administer these assessments under the current protocol. 
 
 
Measures and Assessments: 
NIMH Branch: If participants have completed any of the following measures or assessments as 
part of study 2014-1106 two months or less from the time of enrollment for this study, we will 
not complete them again. Instead, we will obtain this data from the PI’s database (2014-0350).  
WPP Branch: We will not use previously-collected data from any participants who may have 
completed these assessments through study 2014-1106, given the confidentiality rules outlined in 
that study. Participants who consent to the WPP branch will be re-administered each assessment.   
Baseline Assessments:
These measures will be collected prior to the study and group assignment (across multiple visits) 
and used to examine potential moderating variables (see “Measurement of Specific Aims”).  
PTSD: We will determine PTSD diagnosis through the PCL-5. The PCL-5 is a 20-item self-report 
measure that assesses for DSM-5 symptoms of PTSD [52].  
NIMH Branch: If PTSD status has been assessed through protocol 2014-1106 more than two 
months prior to baseline assessments, we will update this information during baseline assessments 
as needed. To update symptoms, study staff will meet with the participant to re-evaluate current 
symptoms of PTSD  
 
Trauma History: We will administer the Trauma History Questionnaire (THQ)† in conjunction 
with the CAPS-5. The Trauma History Questionnaire (THQ) is 24-item scale assessing 
experiences of traumatic events [21]. We will also administer two self-report questionnaires that 
assess distinct (but overlapping) aspects of lifetime trauma and stress exposure: The Life Events 
Checklist-5† (LEC-5; a 17-item self-report measure of potentially traumatic (i.e., life-threatening 
or severely harmful) events during the participant’s lifetime. [22] The LEC-5 will be administered 
the first time the PCL-5 is completed. The Childhood Trauma Questionnaire† (CTQ; 29-item 
scale assessing severity of physical abuse, physical neglect, emotional abuse, emotional neglect, 
and sexual abuse under age 18) [23].  
 
Treatment history: Participants will self-report previous experiences with treatment for any 
psychiatric illness or psychological problems (type of treatment, dates, and perceived benefit).  
 
Demographics: We will collect sex, age, race, and years of education through self-report. Family 
socioeconomic status will be assessed with the Hollingshead questionnaire† [24].  
 
Cognitive function:  We will use scores on the Wechsler Abbreviated Scale of Intelligence- 
Second Edition to measure intelligence, verbal comprehension, working memory, and processing 
speed from protocol 2014-1106 [25].  
 
Substance use history: We will assess substance use history with the Addiction Severity Index 
(ASI)† [27].  

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Medication use: We will collect medication name, dose, and duration of use (past month) 
through self-report. If medication use has already been assessed through protocol 2014-1106, we 
will update this information during baseline assessments.
 
Additional Measures: 
 
Client Satisfaction: We will assess participant satisfaction with therapeutic interventions using the 
Client Satisfaction Questionnaire-8 (CSQ-8) [28]. Participants will complete this at the one-week 
post-treatment timepoint. 
 
Psychopathy: We will assess psychopathic personality traits with the Psychopathic Personality 
Inventory (PPI-SF) [29].  
 
Time served: We will collect time served through participant self-report. 
 
Isolation Time: We will collect data on time spent in Segregated Housing through participant 
self-report. 
 
# of Requests for Services: We will collect data on the number of requests each participant 
requests for psychological services within one year before and after the treatment, as well as any 
requests for psychological services since the beginning of treatment. This information will be 
collected from the DOC central office after the completion of treatment.  
 
# of Actual Service Contacts: We will collect data on the number of contacts each participant has 
with the Psychological Services Unit within the one year before and after the treatment, as well 
as any contacts with the Psychological Services Unit since the beginning of treatment. This 
information will be collected from the DOC central office after the completion of treatment. 
 
# of Clinical Observation Placements (Optional measure for participants): We will collect data 
on the number of clinical observation placements each participant has with the Psychological 
Services Unit within the one year before and after the treatment, as well as any contacts with the 
Psychological Services Unit since the beginning of treatment. This information will be collected 
from the DOC central office after the completion of treatment.   
 
Restricted Housing Placements (Optional measure for participant)s: We will collect data on the 
number of restricted housing placements and how long each restricted housing placement was 
for each participant within the one year before and after the treatment. This information will be 
collected from the DOC central office after the completion of treatment.  
 
Conduct Reports(Optional measure for participants): We will collect data on the conduct reports 
received for each participant within the one year before and after treatment. This information 
will be collected from the DOC central office after the completion of treatment.   
 
Recidivism: Recidivism rates will be provided by the Research and Policy Unit of the Wisconsin 
DOC. This information includes the date of release, 1-, 2-, and 3-year recidivism status (i.e., 
whether someone recidivated during the first, second, or third year after release), and the date of 

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recidivism (if applicable). 
 
Other Current Treatment: Participants will be asked what treatment groups they are currently 
enrolled in during the initial screening. Participants will self-report current and previous 
experiences with treatment for any psychiatric illness or psychological problems (type of 
treatment, dates, and perceived benefit) during baseline, midpoint, and post assessments.  
 
 
Drop-Out: If participants decide to discontinue treatment, study staff will ask participants to 
indicate their reasons for doing so as a measure of treatment acceptability.  
 
Treatment Expectancy: Expectations for treatment will be assessed after session 2 of group 
treatment using the CEQ (Credibility/Expectancy Questionnaire)[30]. 
 
Therapeutic Alliance: Alliance will be measured using the Working Alliance Inventory-Short 
Revised (WAI-SR)[31] and the California Psychotherapy Alliance Scale for Group Psychotherapy 
(CALPAS-P)[32]. Participants will complete these at the one-week post-treatment timepoint. 
 
Questionnaires: 
All participants will complete the same battery of questionnaires and tasks at pre-, mid-, post-, 
one-month and three-month follow-up timepoints. This battery will include: PTSD Checklist for 
DSM-5 (PCL-5) [33], Beck Depression Inventory-II (BDI-II) [34], Beck Anxiety Inventory (BAI) 
[35], Beck Hopelessness Scale [36], the Posttraumatic Cognitions Inventory [37], Buss-Perry 
Aggression Questionnaire (BPAQ) [38], Impulsive Behavior Scale (UPPS-P) [39], and Difficulties 
in Emotion Regulation Scale (DERS) [40], Patient Health Questionnaire (PHQ-9)[60]. 
 
The BDI-II will be reviewed by a study team member immediately after the participant completes 
it. If any participant indicates a desire to harm themselves or commit suicide, the research assistants 
will contact the prison medical staff. This is one of the only instances when the researcher would 
breach confidentiality (participant is risk to harm self, other, reveals plans to escape or start a riot). 
If participant expressed suicidal ideation during any assessments, we will follow up by using the 
Columbia-Suicide Severity Rating Scale Screen Version – Recent (C-SSRS-SV) [41], a scale to rate 
the subject’s risk. We will only ask about ideation within the last month (current). We will ask 
about suicidal ideation and intensity and any suicidal behavior. Participants will be considered at 
suicide risk if they endorse ≥2 on question #9 (suicidal ideation question) of the BDI-II or if they 
endorse any current plan to harm themselves. If a participant endorses a plan to hurt themselves, 
the C-SSRS-SV will be administered to determine suicide risk. If there are any imminent safety 
concerns (i.e., endorses current suicidal ideation/behaviors), research staff will notify the 
institution's psychologist, and the participant will be escorted by prison staff to the mental health 
services office. 
 
Participants will also complete the Patient Health Questionnaire (PHQ-9) [60] weeklt, as a check-
in to monitor depressive symptoms and address suicidal and self-harm risk. The PHQ-9 will be 
reviewed by a study team member after each participant completes it at each timepoint. If 
participants endorse a 1 (“Several days”), 2 (“More than half the days”) , or 3 (“Nearly every day”) 

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on item 9 of the PHQ-9, study staff will immediately follow-up by administering the C-SSRS-SV 
and adhere to the same follow-up protocol outlined above. 
 
Qualitative Data Collection:  
 
NIMH Branch: 
Focus Groups: Focus groups will be aimed at collecting qualitative data examining acceptability 
of group CPT. Focus groups meet 1 time and will occur the week following treatment completion. 
Focus group members will be comprised of the same participants that completed the treatment 
protocol. Focus groups will be conducted by a trained graduate student or study staff member that 
did not lead the CPT treatment groups. Focus groups will last approximately 2 hours and will 
consist of open-ended questions aimed at understanding what participants liked and didn’t like 
about the treatment, such as content, engagement, and format of the sessions. Questions will be 
limited to assessments of the intervention and ways it can be improved regarding issues of 
acceptability; no personal or sensitive information will be collected. 
 
WPP Branch: 
Individual Interviews: Individual interviews will be aimed at issues related to efficacy of treatment 
groups. Participants will complete one individual interview focused on efficacy of their assigned 
treatment at the 1-month follow-up timepoint. This interview will be conducted by trained graduate 
student or study staff members that did not lead either treatment group. Individual interviews will 
last approximately 1 hour. Interviews will consist of open-ended questions aimed at understanding 
the potential effects of the assigned treatments and will address topics such as outcomes following 
treatment and specific skills and concepts. Questions will be limited to assessments of the 
intervention and ways it can be improved regarding issues of acceptability. 
 
Randomization and Blinding: 
 
NIMH Branch: 
Randomization and blinding procedures are not applicable to the NIMH Branch, as there is only 
one condition to which participants will be assigned to. 
 
WPP Branch:  
To ensure that our randomization process results in treatment groups that are balanced on key 
variables that might affect treatment response, participants will be assigned to groups through 
stratified randomization, in which randomization occurs within specific strata of different potential 
moderating variables and assures equal assignment to each group across these variables. 
Participants will be stratified/randomized based on PTSD severity (PCL-5 total score).. The 
stratified randomization will use group code numbers (1 & 2) rather than the intervention title, thus 
eliminating any chance of systematically biasing the group assignment.  
 
While it is impossible for the therapists and participants to be blind to the group assignment, the 
research members performing the pre-treatment, mid-treatment, post-treatment, one-month and 
three-month follow-up assessments will be blind to the group assignment. The study therapist will 
not conduct assessments once participants have assigned to their respective treatments (e.g., pre-, 
mid-, post-, or follow-up assessments).  Additionally, one graduate research assistant will schedule 

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participants according to the randomization, thus minimizing the possibility of systematically 
biasing the outcome and mediator assessments.  
 
Treatment: 
 
NIMH & WPP Branches: 
Each CPT group will enroll 6-8 members and will meet weekly or biweekly for 12 group sessions 
including one follow up CPT session. Participants will be referred to by their preferred first names. 
The CPT protocol will follow the published manual [15]. Session 1 begins with orientation to group 
treatment and group rules, education about PTSD, an overview of treatment, and an assignment to 
write an impact statement about the personal meaning and effect of the traumatic event. After 
reading and discussing the meaning of the traumatic event in Session 2, group members are 
introduced to the identification of and relationship among events, thoughts, and emotions. At the 
end of Session 3, group members are given the assignment of recording events, thoughts, and 
emotions throughout the week to establish the relationships between thoughts and emotions within 
their own lives. During Session 4, cognitive therapy begins with Socratic questions regarding self-
blame and other distortions regarding the event. In Sessions 5-6, the focus of the therapy shifts to 
teaching clients to challenge and change their beliefs about the meaning of the event and the 
implications of the trauma for their lives. Group members are first taught to challenge a single 
thought by asking themselves a series of questions. They are then taught to identify problematic 
patterns of cognitions that have come to represent a style of responding. From that point, beginning 
with Session 7, group members use worksheets that incorporate the earlier activities as well as the 
development of alternative, more balanced self-statements. In Sessions 7-12, group members are 
asked to focus on one of the five core themes of CPT each week (safety, trust, power/control, 
esteem, or intimacy) and correct any overgeneralized beliefs related to that theme. In Session 11, 
group members are asked to rewrite their impact statements to reflect their current beliefs, and 
these revised statements are then used in Session 12 to evaluate gains made in treatment and areas 
in which they wish to continue working. Following the completion of the 12 CPT sessions, an 
additional follow-up group CPT therapy session will be provided. This follow-up CPT session is 
recommended by the CPT manual and typically occurs 2-3 months after the end of the 12-session 
treatment group. The group follow-up CPT session is designed to check-in with participants to see 
how they are doing, work through any problems/difficulties they have had, and to reinforce the 
strategies and skills they learned from the treatment group. At the start of each treatment session, 
the participants will be asked to complete the PCL-5. At the end of treatment sessions, participants 
will be given the option to de-stress for 15-20 minutes.  
 
Treatment notes will be completed after each group session to document the content covered in 
the session and to track the attendance and homework completion of group members.  Group 
members will not receive individual psychotherapy notes, and no information from this study will 
be added to participants’ medical record.  
 
 
WPP Branch: 
The active control course will follow the structure from extant studies using waitlist control groups 
[42]. This group will mirror the CPT group in all aspects of frequency and duration (over 6 to 12 
weeks depending on session frequency, 90-minute sessions) as well as group size (approximately 

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6-8 participants). Treatment notes will be completed after each group session to document the 
content covered in the session and to track the attendance of group members. Group members will 
not receive individual psychotherapy notes, and no information from this study will be added to 
participants’ medical record.  
 
Therapists: 
 
Therapists will receive training prior to administering treatment at a level that will emulate the 
personnel and training resources that will realistically be available in the correctional setting (i.e., 
to make the results of this research program generalizable and scalable to correctional institutions). 
Consultation and clinical supervision/oversight will be provided by licensed clinical psychologists 
with experience in training, student supervision, and clinical research and with particular expertise 
in CPT (Co-I Dr. Monson; Dr. Maine). We believe this level of therapist training will be sufficient 
for this project, as a previous study showed group CPT to be effective for reducing PTSD 
symptoms in a resource-poor country where the therapists had minimal secondary education and 
the patients had extremely limited literacy [43]. 
 
NIMH Branch:  
The therapists for the CPT groups will be a graduate student with masters-level training in clinical 
psychology or a community provider with CPT training. The community provider will also have 
master-level training in clinical psychology or certification as a peer specialist.  
 
WPP Branch: 
The therapists for the CPT groups will be psychological services staff at each facility with CPT 
training.  
 
Measurement of Specific Aims 
 
NIMH Branch: 
Specific Aim #1: Our assessment of feasibility of the interventions will be determined by measures 
of eligibility, participation, retention (primary measure), compliance with intervention activities, 
adherence to intervention elements, competence of intervention elements, and safety.  
 
 
Primary Outcome Measure:  
Retention will be measured as the percentage of residents attending all 12 sessions. 
Retention rates for CPT in non-incarcerated samples are typically 80% or less [15]; hence, 
our study goal is ≥80% retention. Retention is our primary measure of feasibility for this 
aim.  
 
 
Secondary Outcome Measures: 
Eligibility will be measured as the percentage of participants who meet the full set of 
inclusion criteria. We will also compute the percentages of participants who are excluded 
for each individual criterion separately, so we are able to discern the relative impact of each 
criterion on study eligibility.  
 
Participation will be measured as the percentage of eligible participants agreeing to 

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participate. Our study goal is ≥75% participation of eligible participants.  
 
 
Compliance will be measured as the percentage of retained participants performing 
intervention activities during session (e.g., attending to and contributing to the discussion); 
the percentage of participants completing the homework assignment each week; and the 
percentage of participants fully completing the pre-, mid-, and post-intervention 
assessment batteries. Our study goal is ≥80% compliance of participants retained in the 
study. 
 
Adherence by the therapists will be measured by ratings of the presence or absence of five 
session elements (scores 0-5) by the clinical supervisors, as in previous CPT studies [16, 
18]. Adherence ratings will be collected for two audiotaped group sessions out of each 12-
session intervention (16.7% of sessions). Our study goal is adherence scores ≥4 for each 
session. 
 
Competence of the therapists will be measured by ratings of the quality of session elements 
(scores 1-7; 1=“not satisfactory”, 4=“satisfactory”, 7=“excellent”) by the clinical 
supervisors, as in previous CPT studies [16,18]. Competence ratings will be collected for two 
audiotaped group sessions out of each 12-session intervention (16.7% of sessions). Our 
study goal is competence scores ≥4 for each session. 
 
Safety will be measured through the suicidal ideation item on Beck Depression Inventory-
II [34], administered at the pre-, mid-, and post-intervention assessments. Participants who 
endorse current suicidal ideation will be referred to mental health services within the 
institution. 
 
 
In sum, we will consider the study successful in terms of feasibility if we meet the following 
thresholds for each intervention: participation rate ≥75% of eligible participants; retention rate 
≥80% of participating participants; compliance rate ≥80% among retained participants; adherence 
scores ≥4; competence scores ≥4; and ≤10% of participating participants reporting an increase in 
suicidal ideation. 
 
Specific Aim #2: Our assessment of acceptability of the interventions will be determined through 
measures of client satisfaction and reasons for treatment dropout. 
 
Primary Outcome Measure: Acceptability will be measured by client satisfaction using 
participant scores on the CSQ-8. Other studies of CPT [44] have established acceptability of 
interventions using the CTQ-8 when mean scores are ≥ 27; hence, our study goal is scores 
of ≥ 27 on the CTQ-8. Client satisfaction is our primary measure of feasibility for this aim. 
 
Secondary Outcome Measures: Reasons for discontinuation of treatment will be 
measured through participant self-report.  
 
We will consider the study successful in terms of acceptability if client satisfaction mean ratings 

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are ≥ 27 on the CTQ-8. 
 
Specific Aim #3: Our assessment of feasibility of assessment distribution will be determined 
through measures of assessment completion. 
 
Primary Outcome Measure:  
Assessment completion will be measured as the percentage of PCL-5 at each timepoint for 
the number of participants retained at that timepoint. 
 
We will consider the study successful in terms of assessment distribution feasibility if 100% of 
PCL-5 assessments at each timepoint are completed for each participant retained at that timepoint. 
 
WPP Branch: 
Specific Aim #1: To assess preliminary efficacy, we will collect primary and secondary outcome 
data at the pre-, mid-, and all post-intervention time points.  
 
Primary Outcome Measure:  
PTSD symptom severity will be measured with the PTSD Checklist for DSM-5 (PCL-5) 
[33].  
 
Secondary Outcome Measures:  
Depression symptom severity will be measured with the BDI-II [34]. Anxiety symptom 
severity will be measured with the BAI [35]. 
 
Analysis of effectiveness: Treatment efficacy will be determined by the change (from pre-
intervention to post-intervention timepoints) for the primary outcome (PTSD) and 
secondary outcomes (e.g., depression) for each group. Repeated measures ANOVAs will 
be conducted for each group. One-way ANOVA will be used to test for group differences 
in score changes from pre-intervention to post-intervention, with follow-up pairwise tests 
(if warranted), using Tukey’s post-hoc tests. IQ and age will be included as covariates in 
all analyses. 
 
Exploratory analysis of moderators: As an exploratory follow-up analysis, we will examine 
potential moderators of effectiveness (details of measures in “Baseline Assessments” 
above). Following published guidelines for randomized controlled trials [45,46], moderators 
of treatment outcome will be tested in regression models, in which the post-intervention 
primary outcome measure (PCL-5 score) is regressed simultaneously onto 1) dummy-
coded group assignment (CPT vs control), 2) the hypothesized moderator, 3) the group x 
hypothesized moderator interaction, 4) the pre-intervention primary outcome measure 
(PCL-5 score), and 5) any covariates of non-interest. The regression coefficients of interest 
are the main effect of the moderator and its interaction with group. A main effect 
independent of an interaction indicates the moderator predicts symptom reduction 
regardless of group assignment. An interaction with group indicates that the moderator 
predicts symptom reduction more strongly in one of the treatment conditions (i.e., 
specificity of moderation). 
 

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Adherence by the therapists will be measured by ratings of the presence or absence of five 
session elements (scores 0-5) by the clinical supervisors, as in previous CPT studies [16,18]. 
Adherence ratings will be collected for two audiotaped group sessions out of each 12-
session intervention (16.7% of sessions). Our study goal is adherence scores ≥4 for each 
session. 
 
Competence of the therapists will be measured by ratings of the quality of session elements 
(scores 1-7; 1=“not satisfactory”, 4=“satisfactory”, 7=“excellent”) by the clinical 
supervisors, as in previous CPT studies [16,18]. Competence ratings will be collected for two 
audiotaped group sessions out of each 12-session intervention (16.7% of sessions). Our 
study goal is competence scores ≥4 for each session. 
 
Specific Aim #2: To measure previously established mediators of CPT efficacy (hopelessness, 
self-blame, and negative self-related thoughts), as in previous studies with non-incarcerated 
populations [47–49], we will administer the Beck Hopelessness Scale [36] and the Posttraumatic 
Cognitions Inventory [37].  
 
Statistical test of mediation: Mediation analyses will be conducted according to published 
guidelines for randomized controlled trials [45,46] in order to determine the extent to which changes 
in the proposed mediators of treatment effectiveness (described above) account for decreases in 
PTSD symptom severity (PCL-5 score) over the course of treatment. These mediation analyses 
will be conducted with regression models, in which the hypothesized mediator is regressed onto 
group assignment controlling for pre-intervention mediator measures (i.e., path a), and the post-
intervention PCL-5 score is regressed onto the post-intervention mediator measure, controlling for 
pre-intervention measures and group assignment (i.e., path b). The indirect mediation effects (i.e., 
product of a and b paths) will be calculated using bootstrapped confidence intervals [49]. Statistical 
significance of the indirect effect will be concluded if the confidence interval of the indirect effect 
does not include zero. 
 
Current Alternatives to Research Participation:  
Participation in this study will have no effect on the availability of other treatments for potential 
participants. Participants may have the opportunity (or be required) to engage in other corrections-
based treatment groups based on their criminal history (e.g., substance abuse treatment, domestic 
violence treatment, sex offender treatment, anger management), however there is no evidence that 
these treatment protocols influence PTSD symptomology. Outside of group therapy, incarcerated 
individuals may have the opportunity to meet individually with a licensed psychologist or 
psychiatrist semi-regularly (e.g., monthly) depending on their diagnosis and level-of-need. 
 
Participant Recruitment: 
NIMH: Potential eligible participants will be identified through a research database maintained by 
the P.I. (2014-0350). This database includes demographic (e.g. age, race, IQ) and psychological 
variables (e.g., psychopathy score, substance abuse) collected during our initial screening and 
interviewing protocol. Participants who previously scored highly on a self-report measure of PTSD 
symptomology (PTSD Checklist for DSM-5 > 33[33]) that is included in our initial screening 
process will be prioritized for this study. All prison studies that we conduct utilize this database to 
recruit eligible participants.  

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WPP: Potential eligible participants will be identified through the trauma treatment waitlist at the 
facilities. These participants have been screened for active psychosis, suicidality, and self-harm or 
will be identified through a research database maintained by the P.I. (2014-0350). This database 
includes demographic (e.g. age, race, IQ) and psychological variables (e.g., psychopathy score, 
substance abuse) collected during our initial screening and interviewing protocol. Participants who 
previously scored highly on a self-report measure of PTSD symptomology (PTSD Checklist for 
DSM-5 > 33[33]) that is included in our initial screening process will be prioritized for this study. 
All prison studies that we conduct utilize this database to recruit eligible participants.  
 
Study Stopping:  
Participants can withdraw themselves from this study at any time. Participants may be withdrawn 
from the study treatment group under the following circumstances; if they endorse suicidal 
ideations with intent or plan and/or it significantly increases throughout the course of treatment 
(explained below under “Suicidality Risk”), PTSD symptoms significantly worsen over time due 
to treatment per participants report and clinicians’ discretion (explained below under “PTSD 
Symptoms Worsening”), noncompliance with treatment requirements or consistently being 
harmful or disruptive to other group members or the therapist, or serious adverse events directly 
related to treatment. In the event that one of these circumstances occurs and the participant is not 
withdrawn from the study based on clinician discretion, the clinician will document this 
circumstance and rationale. A serious adverse event is classified as life threatening, requires 
inpatient hospitalization, persistent or significant disability or incapacity, or is an important 
medical event [51]. 
 
Circumstances that warrant consideration for termination or suspension include, but are not limited 
to: 
- 
Determination of unexpected, significant, or unacceptable risk to subjects 
- 
PTSD Symptoms Worsening  
o An increase of 10 points or more on the PCL is considered to be clinically 
significant, although there is currently no widely accepted clinically 
significant change on the PCL-5 (which is used to assess PTSD symptoms in 
this study) [55]. Preliminary research suggests a change in score of 15-18 or 
greater on the PCL-5 is a reliable change [59]. Considering that research 
regarding what constitutes a reliable change on the PCL-5 is still ongoing, our 
study will use a more conservative value of a 10-point increase on the PCL-5 
to trigger a meeting between the clinician and participant. As such, if a 
participant has a 10-point or greater increase on the PCL-5 relative to their 
baseline PCL-5 score, the study clinician will check-in with the participant 
regarding their symptoms and safety. If this 10-point or greater increase in 
PCL-5 score relative to baseline is maintained over three weeks, the study 
clinician will check-in again with the participant, and consider withdrawing 
them after 3 weeks of increased symptoms. The study clinician will also meet 
each week with the participant if they have a sustained 10-point or greater 
increase in score relative to baseline as a weekly check-in. In considering 
participant withdrawal, the clinician will make a clinical judgment based on 
the participant’s scores and their expertise as to whether the participant ought 

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to be withdrawn for their safety. This procedure for discontinuing 
participation based on the therapist’s clinical judgment pursuant to worsening 
of PTSD symptoms is consistent with recent clinical trials of CPT conducted 
by leading experts in the field (e.g., Schurr et al., 2022; Sloan et al., 2022)   
- 
Suicidality Risk   
o If a participant scores a 2 or 3 on item 9 of the BDI-II or score a 1, 2, or 3 on 
item 9 of the PHQ-9, the research staff with administer the C-SSRS-SV. If 
any participant indicates “active suicidal ideation with some intent to act” 
(item 4) or “active suicidal ideation with specific plan and intent” (item 5) on 
the C-SSRS-SV, the participant will be withdrawn from the treatment group 
and staff will adhere to the adverse events follow-up protocol outlined in the 
AE sections.   
 
If a participant is withdrawn by the clinician, they will be offered the option to complete study-
related follow-ups. If the participant chooses not to complete the follow-up activities, they may 
withdraw from the study entirely.  
 
WPP Branch Study Stopping Rules:  
1. Participants who miss more than three sessions will not be allowed to rejoin the treatment 
group. Participants will be notified through internal mail or in person following their 
return to group.  
2. Participants will be removed from group if they exhibit self-harming behaviors requiring 
clinical observation.  
3. Lack of engagement as assessed by continually not paying attention during group, not 
completing homework, not taking notes during group, and not engaging in discussion.   
 
Risk/Benefit Assessment  
Known Potential Benefits to the Subjects:  
Participants may experience an improvement in how they are feeling after completing a therapy 
group. However, we cannot promise this will happen. Participation in this research study may 
benefit other people in the future by helping us learn more about how to treat PTSD in currently 
incarcerated individuals. 
 
Known Potential Risks:  
Some subjects may find the questionnaires to be boring or tiring. They may also feel uncomfortable 
with sharing information about their emotions and personality.  
 
While completing the therapy groups, some people may feel upset or emotional talking about their 
feelings and experiences with others. Participants may also experience temporary increases in 
mental health symptoms, like depression, anxiety, sleep disturbances, and other PTSD symptoms 
[56-58;54] Peterson et al. (2022) report that the most common adverse events in their CPT 
treatment for active-duty military and veteran participants with PTSD were mental health 
symptoms, including, nightmares (7.5%), sleep difficulty (5.8%), depression (5.0%), anxiety 
(4.2%), and irritability (4.2%). Similarly, Sloan et al. (2022) report that the most common adverse 
events in their CPT treatment for active service military members with PTSD were mental health 
symptoms such as anxiety, depression, and sleep disturbances. In rare cases, such symptoms can 

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be severe. In a large-scale study of CPT for veterans with military-related PTSD, researchers 
reported the most significant “attributed” or “possibly attributed” adverse event for any of the 
study treatment (psychiatric hospitalization), was “attributed” in only 1 out of 461 CPT 
participants (0.002%) and “possibly attributed” in 6 out of 461 CPT participants (0.01%) [51]. This 
indicates that severe adverse events, such as psychiatric hospitalization, are rare in the context of 
this study and unlikely to be attributable to CPT treatment.    
 
One other risk of taking part in this study is that the participant’s study information could 
become known to someone who is not involved in the study. For instance, someone might find 
out that the participant has a history of trauma. Breaking confidentiality in this way could 
happen if any of the data we collected were to be lost or stolen from the laboratory or if any 
data stored in the electronic database were damaged. 
 
Multiple Sites:  
All data for this study will be collected at OCI, FLCI, or TCI. Dr. Koenigs and his staff have an 
extensive and ongoing program of psychological research with residents at all three sites. Neither 
the prisons nor the Wisconsin Department of Corrections (DOC) has a legally constituted IRB. 
However, the DOC has a formal Research Review Committee. Before conducting research with 
the DOC, it is necessary for investigators to receive both approval by a legally constituted IRB and 
the DOC Research Review Committee.  
 
Research activities conducted at non-UW sites (OCI, FLCI, TCI) will be monitored by experienced 
research staff (graduate students, Research Specialists, P.I.) to ensure that the activities are within 
the guidelines of the protocol. Research team members will be trained to conduct the research 
activities according to IRB guidelines and will immediately report any complications to the 
research staff and the P.I. The P.I. will meet weekly with the entire study team to ensure regular 
communication regarding the study procedures. Any unanticipated problems, adverse events, or 
protocol deviations will be monitored by the study therapists and will then be reported to Dr. 
Koenigs. Examples of potential reportable events include participant drop out due to unexpectedly 
high emotional distress from participating in the group or a participant report of significant 
increase in suicidal ideation. Dr. Koenigs will relay these events to the UW-Madison HS-IRB. If 
any protocol changes are necessary in response to an unanticipated problem, Dr. Koenigs will 
communicate this to the UW-personnel working on the study, and the study therapists will monitor 
such changes on-site to ensure they are followed.   
 
Because the multiple study sites are not involved in the research study (the studies are simply 
conducted at these sites), communication between research staff and the study sites is limited to 
logistics of scheduling (e.g., reserving rooms in the prison). Specific study information (e.g., 
protocol updates) will not be disseminated to the study sites. 
 
The UW-Madison HS-IRB is the only IRB that will be approving documents and consent forms 
for this study. Therefore, there is no need to review IRB approved documents from other sites.   
 
 
 
 

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Monitoring and Reporting Adverse Events: 
A serious adverse event can be classified as life threatening, requires inpatient hospitalization, 
persistent or significant disability or incapacity, or is an important medical event[51]. 
 
Participants will be monitored by a study therapist or study team member during all study visits. 
Study visits include baselines, follow up interviews, treatment groups, and focus groups. At the 
start of every session, the study team or therapist will hand out an independent sheet for each 
participant with the following questions,  
1. “Have you had any significant/negative psychological, social, physical, or other negative 
life events in the last week? ”  
2. How did this event make you feel?  
3. When did this situation happen?  
4. Is the situation ongoing? If not what day/date did it end? 
5. What this situation related to this treatment?  
Once finished, the therapist will collect the document and check the response. The response to this 
question will be tracked and monitored each session. If the adverse events needs follow up, the 
therapist or study team member will have a conversation with the participant.  
 
 The study therapist and study team members will be required to notice any clinically significant 
changes in PTSD symptoms or any worsening symptoms and determine adverse events. The study 
team or study therapists will perform structured assessments (i.e., PCL-5, PHQ-9) each the 
beginning of each group. We will add a 15-minute period at the beginning of each group session 
specifically for check-ins and administration of the PCL-5 and PHQ-9. Scores from the PCL-5 and 
PHQ-9 will be reviewed during this period, and will be added to a tracking document that has 
separate columns for each measure at each timepoint assessment (i.e., baseline, group sessions, 
midpoint, post-treatment). The tracking document will also include columns to indicate whether 
the PCL-5 score has increased by 10 or more points and whether the participant reported a 1, 2, or 
3 on item 9 of the PHQ-9. Additionally, a research staff member will stay in the treatment room 
to assist the study therapist with administration, review, tracking of the participant scores, and 
assessment of SI via the C-SSRS-SV as needed.   
 
The study team will conduct the BDI-II at each timepoint assessment (baseline, mid-, post-, 1 
month, 3 month follow up) . We will also use a tracking procedure to document BDI-II scores 
including whether the participant reported a 2 or 3 on item 9. Additionally, a research staff member 
will administer, review, and track the participant score, and assessment of SI via the C-SSRS-SV 
as needed.  
 
Each change in the PCL-5 or the PHQ-9/BDI-II that meets the definition of an AE will be 
reported appropriately and tracked in REDCap.  
 
If the participant exhibits any significant or unexpected psychological symptoms, social issues, 
physical injuries, or medical injuries during the study the therapist/study team will talk one on one 
about their symptoms and continuation in the group. They will encourage participants to reach out 
to psych services during these one-on-one conversations. Some studies have found temporary 
exacerbations of PTSD symptoms and temporary increases in depression, anxiety, and sleep 
disturbance symptoms for a subset of participants during PTSD treatment [58, 54]. Importantly 

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though, for participants who saw an increase in PTSD symptoms, the increase was temporary and 
they still experienced clinically significant improvement by the end of treatment, indicating the 
treatment’s safety [57]. Similarly, for those who saw an increase in depression symptoms, the 
increase was temporary and did not have a strong impact on the participants' treatment 
outcome[57]. One study did show that in rare cases, such symptoms referenced can be severe (see 
“Potential Risks” above for more information)[54]. Ultimately, previous studies found that 
although some participants may experience transient increases in mental health symptoms, like 
depression and PTSD related symptoms, confronting past traumas is overall still a safe and 
effective intervention strategy. There is an option at the end of each session for 15-20 minutes for 
participants to de-stress and relax if they are emotionally distressed from session content.  
 
The study therapist or study team member will be required to track each adverse event using the 
adverse events tracking spreadsheet and designated follow up questions. The adverse events 
tracking spreadsheet will include a description of the event, start and stop date, severity grade, 
relatedness grade, action taken, outcome, and whether the event qualifies as a serious adverse 
event. The follow up questions are as follows; “How has this impacted you? (to get at severity), 
Has this been affected by your participation in the treatment? (e.g., is group making your 
experience/symptoms worse, or is this directly caused by treatment). Follow up questions will be 
up to the study personnel dependent upon what the participation has shared. The study team will 
also record the event and its details using our electronic database, REDCap. The participant may 
be withdrawn per the discretion of the study therapist and clinical supervisors.  
 
Guidelines for assessing the severity and study relatedness of each adverse events will follow the 
procedures outlined in Schnurr et al., 2022 and collaboratively determined by the study therapist 
and study team. 
 
Severity: 
Mild: Does not interfere with daily functioning/normal activities  
Moderate: Interferes with normal activities to some extent 
Severe: Interferes significantly with normal activities 
 
Relatedness: 
1. Not attributed to a study intervention 
2. Possibly attributed to a study intervention 
3. Attributed to a study intervention 
 
An adverse event will be considered associated with the study if there is a reasonable possibility 
that the event was caused by the treatment or by an individual’s participation in the research study. 
Any event with a reasonable causal relationship will be considered related.  
 
The reporting period of adverse events begins from when participants sign the informed consent 
form until their final study visit (3-month follow-up visit), or until participants withdraw 
themselves from the study, whichever is sooner. All adverse events will be tracked using the 
Adverse Events tracking form. When adverse events occur, we will follow the Health Sciences 
IRB Unanticipated Problems Reporting Decision Tree.   

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Data and Safety Monitoring Plan/Data and Record Keeping:  
 
We plan to utilize the UW ICTR Data Monitoring Committee (DMC) to oversee the study across 
all participating sites. The UW ICTR DMC is comprised of experienced members (core plus ad 
hoc) with expertise required to oversee this study. The DMC members will review protocol-
specific reports created by statisticians using data pulled from the Research Electronic Data 
Capture (REDCap) data management tool. These standard reports will include an overview of 
study objectives, a review of actual and projected accrual rates, an evaluation of patient 
demographics for balance of randomization, and a summary of the number and seriousness of 
adverse events. An interim analysis of study results may be requested, and source documents may 
be reviewed to allow the DMC to independently judge whether the overall integrity and conduct 
of the protocol remain acceptable based on data provided and reported by the Principal 
Investigator. The DMC will make recommendations to the Principal Investigator that could include 
actions of continuation, modification, suspension, or termination. 
 
In providing oversight for the conduct of this study, the ICTR DMC will meet every 6 months 
during the 3-year study to review all adverse events. Additional meetings may be scheduled as 
determined by the DMC or as requested by the PI. We will submit all reportable events to the 
DMC and the UW-Madison HS-IRB in accordance with their reporting guidelines. Additionally, 
Dr. Koenigs will review weekly progress reports that characterize the overall quality of each 
session and any unexpected events. 
 
Data from this study will exist in a combination of electronic (computer) and paper files. We will 
use ICTR’s instance of REDCap to support electronic data collection and storage. Data will be 
collected primarily on the REDCap Mobile App, a highly secure application that provides the 
ability to collect data offline. Offline data collection is required because of a lack of internet access 
at each prison. The REDCap Mobile App requires users to enter a username and unique pin to 
access the project, and data is encrypted on the device’s hard drive. Data collected on the REDCap 
Mobile App will regularly be removed from the mobile device through transmission to the 
project’s REDCap server. To protect the confidentiality of the electronic information, all electronic 
data will be coded, and the REDCap data collection project will not be stored with any personally 
identifying information. The code file with identifiers will always be stored separately from the 
coded electronic data under password protection. 
 
Data collected on paper forms will be entered through REDCap’s web-based application and stored 
on the project’s REDCap server. The paper files will be coded, such that only a five-digit numerical 
code (not identifiable information such as the participant's name or birth date) will appear on the 
paper files. The paper files (i.e., questionnaires) will be stored in a locked file cabinet at the facility, 
only accessible by the DOC study therapists. At midpoint data collection, research staff will 
transfer the paper data from the first 6 sessions to a cabinet in a locked office in the P.I.'s laboratory 
in the Department of Psychiatry or locked filing cabinet in the Department of Psychology. At post-
test data collection, research staff will transfer the paper data from the following 6 sessions to a 
cabinet in a locked office in the P.I.'s laboratory in the Department of Psychiatry or locked filing 
cabinet in the Department of Psychology. Access to the locked offices/cabinets will be limited to 
the members of the study team listed in this application.  
 

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The CAPS-5, treatment sessions, post-treatment focus groups (NIMH Branch), and post-treatment 
individual interviews (WPP Branch) will be recorded using DOC-approved digital audio recording 
devices. Audio recording devices will be password protected. Electronic data will be stored on a 
secure departmental server that is HIPAA compliant. To protect the confidentiality of the 
electronic information, all electronic data will also be coded, so the participant information will 
not be stored with any personally identifying information. The code file with identifiers will always 
be stored separately from the coded electronic data. The code file will be encrypted using a 
commercially available encryption program. The file will be unreadable without the encryption 
key. Therefore, even in the unlikely case that the files were somehow accessed inappropriately, 
the identifiable participant data would still be protected by the encryption. Hard copies of the 
encryption key for the code file will be stored by Dr. Koenigs (in a locked cabinet in his locked 
office) and by the Department of Psychiatry IT staff (in a locked cabinet in a separate locked 
office). 
 
Study staff will use a HIPAA compliant UW-Madison Secure Zoom account to conduct 
virtual assessments. For these virtual visits, correctional staff will escort the participant to the 
private testing room but will not be present during the assessment. 
 
 
Unspecified Future Research 
The study data will be used only by Dr. Koenigs' research team at UW-Madison. Only the UW-
Madison study team personnel listed in this application will have access to the participant 
identifiers. The study data will be stored indefinitely in the database described in 2014-0350. 
Participants will have the option, at the time of consent, to give their permission to share data in 
the case of unspecified future research. Data will only be shared for future use with UW-Madison 
affiliates. We will not share data with any other companies or organizations, and any data that is 
shared will be stripped of identifiers. 
 
Data that may be used for future research includes all symptom outcome measures collected 
throughout this study, and if a participant completed the CPT group. This data will be added to our 
current approved database protocol (2014-0350). The following information is included in this 
protocol, and applies to our future use of the data collected in this study: 
 
#2014-0350: This project will involve no procedures or interventions. There will be no  
interaction with participants. This application is for the creation of a database only. 
 
The database will be used to identify characteristics of incarcerated individuals (e.g., 
personality traits, mental health diagnoses, cognitive test scores, demographic data, etc.) 
that relate to criminal behavior. We will also use the database to retain the names of 
residents who have agreed to be contacted for future research studies. Dr. Koenigs will be 
the P.I. on any future studies that use data from this database, as well as on studies that 
contribute data to this database. 
 
The data from this database exist in a combination of electronic (computer) and paper 
files. The electronic data are stored in single encrypted spreadsheet file, which will be 
stored on a secure password-protected Department of Psychiatry server. The paper files 

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will be stored in a locked cabinet in a locked office in the P.I.'s laboratory. To protect the 
confidentiality of the database information, all participant data will be coded, so the 
participant information will not be stored with any personally identifying information. 
The key that identifies individual participants will be encrypted and stored separately 
from the database file. All paper study data (e.g., questionnaires, surveys, etc.) will be 
stored in locked file cabinets in a locked office. Paper study data will include codes only 
(no names or other identifiable information in the paper records). All electronic study 
data will be encrypted and stored on a secure server. Because the majority of the data 
included in this database contains old data (although some data will be added from 
studies that are currently open), and because we will take sufficient care to protect the 
confidentiality of the study data, we believe that the risks to participants are minimal. The 
potential benefit to society is considerable; by developing a better understanding of the 
psychological, behavioral, demographic, and environmental characteristics the contribute 
to criminal recidivism, this research could lead to more effective diagnostic and treatment 
strategies for criminal offenders. 
 
Any individual studies that contribute to this database which are currently open for data 
collection will remain open for data collection, and the data will be added to the 
database.  
 
Since some of the individual studies that will contribute to the database have Certificates 
of Confidentiality (CoC), we will obtain an amended CoC for this research database. 
 
The data in this database will be used only by Dr. Koenigs' research team at UW-
Madison to identify relationships between psychological assessment information, self-
reported personality traits, and criminal history and behavior. 
 
All future uses of the database will be submitted to the IRB. The study P.I. (Dr. Koenigs) 
will oversee all data transfer, storage, and analysis. Any unanticipated problems or 
complications will be reported immediately to the MR-IRB. 
 
Human Participants Considerations Specific to Incarcerated Populations: Given the incarcerated 
status of potential participants, we outline several additional protections: 
 
1. Potential research participants will be identified by the research team—no correctional staff 
will be involved in the identification of potential participants for this research study.  
Participants will be randomly selected from the database of residents that meet the 
eligibility criteria.   
 
2. It will be emphasized to participants that participation in the study will have no effect on 
incarceration status, and that study results will not be shared with correctional staff.  In 
addition, it will be emphasized to correctional staff that individual study results will not be 
shared with residents or correctional staff.  
 
3. The consent, assessment and treatment will occur in a private room, without the presence 
of correctional officers.  

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4. The questionnaires and treatment protocol used in this study are common techniques for 
healthy populations, and do not provide any risk to residents that would not be encountered 
by non-incarcerated populations. We thus anticipate the creation of only minimal risk from 
these procedures, similar to those that would be encountered in non-incarcerated 
populations. 
 
5. In this study we are enrolling incarcerated individuals who may or may not have completed 
high school education and may have limited reading skills. We are taking several 
precautions to ensure that participants in this study can understand the written consent 
information. To ensure that all study information is presented in language that is 
understandable to the resident, all consent material is written so as to be readable to an 
individual with a 4th grade reading level. During the consent procedure, residents are 
encouraged to ask the research staff for definitions of any words that they do not 
understand. We will exclude any participants who have an IQ below 70 or reading level 
below 4th grade. Thus, we can be sure that all participating residents will have sufficient 
reading skills to make informed decisions throughout the study procedures. 
 
Under DHHS 45 CFR 46.306(a)(2), biomedical or behavioral prisoner research may only be 
conducted if the research involves specific criteria. This proposed study satisfies criterion (i) 
“Study of the possible causes, effects, and processes of incarceration, and of criminal behavior”. 
 
Regarding criterion (i), this study is designed to identify psychological and affective factors that 
may predispose a person to criminal behavior and incarceration in order to effectively design and 
implement treatment programs. Specifically, PTSD severity has been linked to increased risk of 
recidivism, and trauma is a hypothesized precursor to criminality [2,3,10]. 
 
Statistical Considerations: 
 
NIMH Branch: 
The primary goal of this study is to establish feasibility of the target intervention (CPT). Hence, 
we base our power analysis on the “retention” data collected Specific Aim #1 (i.e., the percentage 
of participants completing the CPT intervention). A sample size of n = 32 for the CPT group will 
provide 80% power to perform a one-sided test where the null hypothesis is 60% retention 
(approximately the lowest retention rate reported in previous CPT trials, versus the alternative 
hypothesis of 80% retention (our study goal), with a Type I error of 5%.  
 
WPP Branch: 
The primary goal of this study is to examine efficacy of the target intervention (CPT). Therefore, 
we will use the same target sample size (n = 32) used to establish feasibility of the target 
intervention, as this reflects the number of participants needed to conduct powered analyses based 
on the lowest retention rate reported in previous CPT trials. 
 
Both the NIMH and WPP branches satisfy this condition with sample sizes of n = 60  for the CPT 
groups and sample sizes of n = 60 for control groups (WPP branch only). 
 
 
 

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Brownley, K. A., Olmsted, K. R., Greenblatt, A., Weil, A., & Gaynes, B. N. (2016). 
Psychological treatments for adults with posttraumatic stress disorder: A systematic review 
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20. Weathers, F. W., Blake, D. D., Schnurr, P. P., Kaloupek, D. G., Marx, B. P., & Keane, T. M. 
(2013). The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview Available 
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psychometric properties of the trauma history questionnaire. Journal of Loss and Trauma, 
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27. Mclellan, A. T., Kushner, H., Metzger, D., Peters, R., Smith, I., Grissom, G., Pettinati, H., & 
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Version Date: 11/27/23
UNIVERSITY OF WISCONSIN-MADISON
Subject CONSENT to Participate in Research 
And
AUTHORIZATION to Use and/or Disclose Identifiable Health information for 
Research
Title of the Study: PTSD treatment for incarcerated men and women
Principal Investigator: Michael Koenigs, PhD (phone: (608) 263-1679), University of 
Wisconsin-Madison, Department of Psychiatry
Mailing Address: 6001 Research Park Blvd., Madison, WI 53719
Student Researchers: Odile Rodrik (phone: (608) 263-1679), University of 
Wisconsin-Madison, Department of Psychology
INVITATION
You are invited to participate in this research study about the treatment of PTSD 
(posttraumatic stress disorder) for people who have been in trouble with the law. PTSD 
is a reaction that people sometimes have after experiencing really negative and 
traumatic things. You are invited to take part because you have previously participated 
in our studies and have agreed to be contacted for additional studies. Approximately 
72 individuals will participate in this study. Your participation in this research study is 
voluntary. If you decide not to participate, your treatment at this institution will not be 
affected in any way.
The purpose of this consent and authorization form is to give you the information you 
need to decide whether to be in the study. It also explains how health information will 
be used for this study and for other research in the future, and requests your 
authorization (permission) to use your health information. Ask questions about anything 
in this form that is not clear. If you want to talk to your family and friends before making 
your decision, you can. When we have answered all your questions, you can decide if 
you want to be in the study. This process is called “informed consent.”
Funding for this study is provided by the National Institutes of Health.
A. WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of the research is to learn more about how to treat PTSD in incarcerated 
individuals throughout several Wisconsin prisons. Researchers at the University of 
Wisconsin–Madison are conducting the study. Many people in prison have experienced 
trauma, but very few people in prison have access to PTSD treatment, called Cognitive 
Processing Therapy (CPT). This research will help identify if a PTSD treatment group 
that is used in community settings is helpful in reducing PTSD symptoms among people 
who are incarcerated. The goal of CPT is to create a space for people to modify 
unhelpful beliefs related to trauma.
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B. WHAT WILL MY PARTICIPATION INVOLVE?
If you decide to participate in this research, you will be asked to complete an interview 
to determine if you are currently experiencing symptoms of PTSD. If you are 
experiencing symptoms of PTSD, you may be invited to participate in a 6- or 12-week 
therapy group.
If you agree to participate, you will be included in a treatment group. The treatment 
group will focus on talking about how past experiences (for example, traumatic 
experiences) may have affected the way you think, act, and feel. The groups will meet 
for  120 minutes, over 6 to 12 weeks, depending on session frequency. There will be up 
to 10 group members in each group. In addition to the treatment sessions, group 
members will be asked to complete weekly “homework” worksheets to help build the 
skills talked about in the group. The treatment session will be led by a masters level 
clinical student or community provider with masters-level training in clinical psychology 
or social work or certification as a peer specialist. 
You will also be asked to fill out questionnaires about how you are feeling (e.g., your 
mood, PTSD symptoms), and your experience in the group. You will complete these 
questionnaires on five separate occasions: once before the treatment group starts, 
once during the treatment group, once one week after the treatment group ends, 
once a month later, and once three months later. Some sessions will take place in 
person and some session may take place over Zoom. The questionnaires will take 
around 20 minutes to complete each time, and can be completed at your own pace 
with a tablet. A study team member can also read the questionnaires aloud, and 
record your answers. The week after the treatment group ends, a study team 
member will lead a  group conversation for approximately 2 hours where you will be 
asked about what you liked or didn’t like about the treatment. Finally, when the 
treatment group ends, you will also be asked to complete an interview about your 
current PTSD symptoms. As part of the study we will collect audio recordings of the 
therapy groups, interviews, and group conversation. The recordings will be used by 
a UW-affiliated doctor (psychologist) to check the therapists’ skills and  their ability to 
run the groups, or by a study team member to make sure the study team are 
assessing PTSD symptoms the correct way. Recordings will be not be shared with 
anybody else. Recordings will also be used to make sure we keep track of 
everything that participants liked or didn’t like about the treatment groups. 
Recordings will be destroyed when the study is finished.
None of this information will be added to your medical records or institutional files. A 
general group note will be made to document the material covered in each treatment 
group, and to keep track of attendance and homework completion. No specific 
information about group members  will be included in this note and this information will 
not be added to your records.
The other data collected in this study may be stored without an end date in a database 
that will allow us to compare your data with data from other incarcerated individuals. If 
you have participated in our research in the past, this database will include other 
information about you that we have collected from other studies. The information we 
store about you will not include your name. Instead, we will code your data with a five-
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digit number. This number will be linked to your name, but only study researchers will 
be able to connect your name and your unique five-digit number.
C. HOW WILL WE USE YOUR PERSONAL HEALTH INFORMATION (PHI)
Protected health information, also called PHI, is information about your physical or 
mental health that includes your name or other information that can identify you, like your 
date of birth or medical record number. To do this study, we will use the following kinds of 
PHI:
 
Results of tests or procedures done as part of the study
 
Things you tell the research team about your physical and mental health
D. IS BEING IN THIS STUDY DIFFERENT FROM MY REGULAR HEALTH CARE?
If you take part in this study, the main difference between your regular care and the care 
provided through this research study is that this study is focused on PTSD symptoms.
You may be able to get PTSD treatment on an individual basis with Department of 
Corrections psychologists and mental health staff, but the type of PTSD group treatment 
this study is using is not currently offered in Wisconsin prisons.
E. WHAT ARE MY OTHER CHOICES IF I DO NOT WANT TO PARTICIPATE?
You do not have to be in this research study to get care for your PTSD. If you decide 
not take part in the study, you have other choices. You may choose to talk to a 
Department of Corrections psychologist about your symptoms, or you may choose to 
take part in a different study, if one is available.
F. ARE THERE ANY BENEFITS TO ME?
You may experience an improvement in how you are feeling after completing a therapy 
group. However, we cannot promise this will happen. Your participation in this research 
study may benefit other people in the future by helping us learn more about how to treat 
PTSD in incarcerated individuals.
G. WILL I BE PAID FOR MY PARTICIPATION?
You will receive $5 per hour for participating in this study. If you complete all parts of the 
study (i.e., assessment sessions, 12 therapy group meetings), you will receive around 
$180. This money will be deposited into your account through the DOC.  
H. WILL BEING IN THIS STUDY COST ME ANYTHING?
There will be no cost to you for the group therapy sessions and assessments that are 
part of this research study.
I. ARE THERE ANY SIDE EFFECTS OR RISKS TO ME?
Some subjects may find the paper-and-pencil questionnaires to be boring or tiring,and 
you may feel uncomfortable with sharing information about your emotions and 
personality.
During the therapy groups, some people may feel upset or emotional talking about 
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their feelings and experiences with others. Also, you may experience a temporary 
increase in feelings of depression, trouble sleeping, anxiety, unwanted thoughts or 
memories of the event, negative changes in your thinking or mood, avoidance, and 
changes in your physical or emotional reactions. If you experience increases in these 
mental health symptoms during treatment, please let the study therapist know.  
One other risk of taking part in this study is that your study information could become 
known to someone who is not involved in the study. For instance, someone might find 
out that you have a history of trauma. If this happens, it could result in damage to your 
reputation or be embarrassing. Breaking confidentiality in this way could happen if any 
of the data we collected were to be lost or stolen from the laboratory or if any data 
stored in the electronic database were damaged.
J. HOW WILL MY PRIVACY BE PROTECTED AND WHO WILL USE MY HEALTH 
INFORMATION?
We have strict rules to protect your personal information and protected health 
information (PHI). We will limit who has access to your name, address, phone number, 
and other information that can identify you. We will also store this information securely. 
We may publish and present what we learn from this study, but none of this information 
will identify you directly without your permission. To protect your personal information, 
we use numbers instead of your name on all materials. Your name never appears in the 
same place as your responses. In order to keep correct records of participation, we 
must keep a key that allows us to link your identification code back to identifying 
information (i.e., names), but this key is stored in a secure place at our university. To 
protect your privacy, we keep these numbers and your responses separate at secure 
locations at the University of Wisconsin-Madison. We will contact the prison and/or 
DOC (and confidentiality will be broken) only under three conditions: (1) If you 
tell us that you plan to hurt yourself or someone else; (2) if you tell us that you 
plan to escape or start a prison riot; or, (3) if you report any sexual activity or 
sexual assault between resident or between residents and staff. Otherwise, we 
will not share your information with anyone, including other residents, prison 
staff, or other authorities.
We will ask you questions about depression, including thoughts and plans to 
harm yourself intentionally, throughout this study. If you report current plans to 
harm yourself, we will need to break confidentiality to let the psychologist at the 
prison know. If this occurs, we will talk to the psychologist right away. Mental 
health services at the prison will then follow up with you. If you report significant 
symptoms of depression, we will refer you to mental health services in the 
institution.
However, we cannot promise complete confidentiality. Federal or state laws may 
require us to show information to university or government officials responsible for 
monitoring the study.
The information collected from you during this study will be used by the researchers and 
research staff of the UW-Madison and its affiliates (the University of Wisconsin Hospital 
and Clinics and the University of Wisconsin Medical Foundation) for this study. It may 
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also be shared with others at the UW-Madison and outside the UW-Madison.
Others at UW-Madison and its affiliates who may need to use your health 
information in the course of this research:
• UW-Madison regulatory and research oversight boards and offices
• Accounting and billing personnel at the UW-Madison
• The National Institutes of Mental Health, the study sponsor
• Federal research oversight and regulatory agencies
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This website will not include information that can identify you. At 
most, the website will include a summary of the results. You can search this website at 
any time.
K. WILL INFORMATION FROM THIS STUDY GO I MY MEDICAL RECORD?
None of the information we collect for this study will be put in your medical record.
L. IS MY PERMISSION VOLUNTARY AND MAY I CHANGE MY MIND?
Your permission is voluntary. You do not have to sign this form and you may refuse to 
do so. If you refuse to sign this form, however, you cannot take part in this research 
study. If you decide to be in the study, the researchers will tell you about new 
information or changes in the study that may affect your willingness to continue in the 
study.
If you decide not to take part in the study, or if you choose to leave the study, your 
choice will not affect any treatment relationship you have with healthcare providers at 
UW-Madison, UW Health, or any affiliated organizations, or any services you receive 
from them. No matter what decision you make, and even if your decision changes, 
there will be no penalty to you. You will not lose medical care or any legal rights. It is 
possible that the researchers involved in this study will choose to stop the study and 
end your participation, even if you choose to participate today. This could happen if a 
safety concern associated with the treatment is identified. You will be notified if such a 
situation happens.
Your authorization for researchers to use your protected health information (PHI) will 
last until the study is done. If you participate in the data banking part of the study, your 
authorization for the banking does not have an end date. However:
●
You can choose to take back your authorization for researchers to use your 
health information. You can do this at any time before or during your 
participation in the research.
●
If you take back your authorization, information that was already collected may 
still be used and shared with others, but the researchers will no longer be able to 
collect NEW information about you.
●
If you take back your authorization, you will not be able to take part in the 
research study.
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To take back your authorization, you will need to tell the researchers by writing to the 
Lead Researcher: Michael Koenigs, PhD, 6001 Research Park Blvd., Madison, WI 53719
You may completely withdraw from the study at any time. You also may choose to stop 
participation or skip any questions that you do not feel comfortable answering. If you 
withdraw, you will be paid for any tasks that you already completed, and your previous 
data will be included in the study. You also may be withdrawn by the study team if it is 
in your best interest. 
IF YOU DECIDE NOT TO PARTICIPATE IN THIS STUDY OR IF YOU STOP WHILE 
THE STUDY IS UNDER WAY, IT WILL NOT AFFECT YOUR STATUS IN THE 
PRISONS OR WITH THE DEPARTMENT OF CORRECTIONS. YOUR 
PARTICIPATION WILL HAVE NO EFFECT ON PAROLE DECISIONS.
M. WHO SHOULD I CONTACT IF I HAVE QUESTIONS?
Please take as much time as you need to think over whether or not you wish to 
participate. If you have any questions about this study at any time, contact the Principal 
Investigator Michael Koenigs, PhD at (608) 263-1679. You can mail Dr. Koenigs at 6001 
Research Park Blvd., Madison, WI, 53719.
 If you have any questions about your rights as a research participant or have 
complaints about the research study or study team, call the confidential research 
compliance line at 1-833-652-2506. Staff will work with you to address concerns 
about research participation and assist in resolving problems.
You can mail the UWHC Patient Relations Representative at 600 Highland Ave., 
G7/210, Madison, WI, 53792.
N. OPTIONAL STUDY ACTIVITIES
This part of the consent form is about additional studies that you can choose to take 
part in. Things to know about these studies:
<0000>
They are optional. 
 
You can still take part in the main study even if you say “no.”
 
These studies will not help you directly, although you may experience less PTSD 
symptoms if you complete the treatment. We hope the study results will help other 
people with PTSD.
 
We will not tell you the results of these optional studies, and we will not put the 
study results in your medical records.
 
Taking part in the optional studies will not cost you 
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Version Date: 11/27/23
Data Storage for future unspecified research:
In the past, we have run other studies at this facility, including brain imaging (MRI) 
studies. If you have participated in these studies in the past, we may wish to compare 
your data from this study to data from past studies. If you do not give us permission to 
continue to store your previous data to use with these data, we will not link your data 
with other information, or information from other studies. Any data you provide will be 
coded and stored in electronic and paper form in locked cabinets and secure computers 
in our research facilities. The research team will maintain a link between your data and 
your identifiable information kept by the study team. Stored data will not be shared with 
your health care providers or used in your treatment outside this study. Data would be 
stored for research purposes only, and may be stored indefinitely.
We will store this data with other data we have collected from you throughout your 
participation in other studies. Because of this, loss of confidentiality is a possible risk 
associated with allowing us to store your data. For example, if someone broke into 
the locked cabinets or hacked into the secure computers and stole this data, they 
would also have access to other data we have collected (e.g., about drug use). This 
could pose a risk legally, or to your reputation.
If you give us permission to continue to store your previously collected study data and 
use it in combination with data from this study, please initial here:
.
Data Sharing:
Data will only be shared for future use with UW-Madison students or employees. We will 
not share data with any other companies or organizations. Any data that is shared will not 
include any identifiable information about you. For example, when we give your data to 
other investigators for research projects, they will not be able to use the code to figure out 
which data are yours.
If you give us permission to share data with other researchers, please initial here:_____
IRB Approval Date: 12/7/2023              
University of Wisconsin – Madison

Version Date: 11/27/23
AGREEMENT TO PARTICIPATE IN THIS STUDY AND PERMISSION TO USE 
AND/OR DISCLOSE MY HEALTH INFORMATION
You do not have to sign this form. If you refuse to sign, however, you cannot take part in 
this research study.
If you sign the line below, it means that:
●
You have read this consent and authorization form.
●
You have had a chance to ask questions about the research study, and the 
research team has answered your questions.
●
You want to be in this study.
●
You give authorization for your protected health information to be used and 
shared as described in this form.
Name of Participant (please print): 
Signature of Participant
Date
YOU WILL RECEIVE A COPY OF THIS FORM AFTER SIGNING IT.
Signature of person obtaining consent and authorization:
Signature
Date
IRB Approval Date: 12/7/2023              
University of Wisconsin – Madison