PTSD Treatment for Incarcerated Men and Women
Condition: PTSD
Study type: Interventional

Summary: 
      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 prison inmates exceeding 20%, as opposed to 3-6% in the
      general population. Cognitive Processing Therapy (CPT) is a potentially promising PTSD
      treatment for the prison setting.

      The primary objectives of this project include:

        1. Establish the feasibility of group CPT delivery in male and female prisons with PTSD by
           examining participant retention in the 12-week course;

        2. Obtain preliminary efficacy estimates for reducing PTSD symptom severity, as well as
           secondary symptoms associated with trauma, including depression, hopelessness,
           self-blame, and negative self-related thoughts.
    

Detailed description: 
      PTSD is associated with an increased risk for crime-related behaviors, such as violence and
      substance abuse. 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 the
      criminal offender population, and no randomized controlled studies that have tested the
      efficacy of empirically-supported PTSD treatments in the prison setting. The treatment
      programs offered to prison inmates (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 offender 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 intelligence (IQs), or comorbid
      psychiatric disorders. In studies of non-incarcerated individuals, CPT has been found to be
      more effective than wait-list control and equivalent to Prolonged Exposure. 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. However, the
      generalizability of these findings to the offender population has not yet been determined.
      This research study will determine whether CPT is indeed an effective and feasible treatment
      for PTSD in inmates, or whether different treatment strategies need to be developed.

      Hypotheses:

      Regarding Aim 1, it is predicted that feasibility will be established by obtaining ≥80%
      participant retention for the CPT course. Additional metrics of feasibility will assess
      eligibility; participation; compliance; adherence; competence; and safety.

      Regarding Aim 2, it is predicted that PTSD symptom reduction will be greater among CPT
      participants than waitlist control participants. Furthermore, it is predicted that reductions
      in depression, hopelessness, self-blame, and negative self-related thoughts will also be
      greater in the CPT group.

      This study will screen approximately 100 participants for eligibility over 2 years. Over the
      two-year study, two 12-week sessions of CPT will be run in each of the two prisons (one
      housing male offenders and one housing female offenders).

      A total of 64 inmates (32 male and 32 female) will participate in group randomization. In
      order to generate a sufficient pool of eligible subjects who meet inclusion criteria for the
      study, approximately 200 inmates per year will be interviewed and screened (100 male and 100
      female per year) during the two-year study period (400 total screened for eligibility; 64
      total enrolled in the study).

      Research Design and Procedures:

      Potential participants will be contacted by calling them over the phone system within the
      prison. Potential participants arrive to a private testing room and are asked if they would
      like to learn about the study and potentially participate. If so, the consent process will
      begin.

      Eligible participants will first complete the Structured Clinical Interview for Diagnostic
      and Statistical Manual of Mental Disorders (DSM)-5 (SCID-5) to ascertain current PTSD
      symptomology and diagnosis. This assessment will take approximately 1-2 hours. Participants
      may have recently completed the SCID-5 as part of a separate study (2014-1106
      "Neuropsychological screening and testing for University of Wisconsin (UW)-Department of
      Corrections (DOC) collaborative research project"). Participants who have completed the
      SCID-5 as part of study 2014-1106 less than two months from the time of enrollment for this
      study will not complete the SCID-5 again, the SCID-5 information obtained from study the PI's
      database will be used.

      Participants will then be assigned to CPT or a control group. The CPT group will engage in
      12, 90-minute treatment sessions (18 hours total). CPT group-members are asked to complete
      weekly homework (approximately 12 hours total). Approximately 8 participants will be included
      in each CPT session. Participants with PTSD will be randomized to the CPT group or control
      group. Participants will be notified via institutional mail when they are starting CPT, or if
      they have been randomized to the control group. The control group will be asked to complete
      the same pre-, mid- and post-treatment questionnaires as the CPT group, but they will not
      engage in the study intervention. Participants in the control group will be able to continue
      any ongoing treatment/interventions they are engaged in within the institution. All
      participants will be asked what treatment groups they are currently enrolled in during the
      initial screening to examine the possibility of attentional bias within the CPT group (i.e.,
      more frequent interaction leading to treatment outcomes).

      The control group will be asked to complete three sessions in total (pre-, mid-, and
      post-testing), and will complete these assessments on the same timeline as the CPT group
      (described above).

      Initial assessment and study consent will be conducted by trained graduate students and/or
      advanced undergraduates with extensive experience working on our prison project. All
      treatment groups will be conducted by an advanced graduate student in the clinical psychology
      program, with supervision provided by a licensed clinical psychologist.

      Treatment notes will be completed after each group session to document the content covered in
      the group 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.

      To ensure that the randomization process results in CPT and control group 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 scores. IQ and age
      will be included as covariates in all analyses.

      Treatment:

      The CPT group will include up to 8 members and will meet weekly for 12 sessions in total.
      Participants will be referred to by their preferred first names. The CPT protocol will follow
      the published manual. Session 1 begins with education about PTSD, an overview of treatment,
      and an assignment to write an impact statement about the personal meaning 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 cognition 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.

      The therapist for the CPT group has master's level training in clinical psychology. She will
      be trained through 16 hours of initial individual training plus five additional hours over
      the course of the treatments (21 hours total). This level of training emulates the personnel
      and training resources that would realistically be available in the correctional setting
      (i.e., to make the results of this research program generalizable and scalable to
      correctional institutions). Training will be provided by a licensed clinical psychologist
      with experience in student supervision and clinical research and with particular expertise in
      CPT. This level of therapist training is believed to 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.
    

Intervention name(s): Cognitive Processing Therapy
Intervention type(s): Other
Intervention description(s): Group-based psychotherapy.
Other intervention name(s): CPT
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment