Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive Behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 2 RCT
Phase: NA
Conditions: Suicide, Psychosis
Sponsor: University of Michigan

 
0 
Identifiers: NCT05345184 
Unique Protocol ID: HUM00211008 
Secondary IDs: R34MH123609 
 
Title: Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2 
 
Contents: Aim 2 Protocol (Approved for use by IRB on 3/22/2024) 
 
Note: Any mention of Aim 1 stakeholder phase or Aim 1 is informational and pertains to 
NCT04689867 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1 
SPECIFIC AIMS 
Suicide is among the leading causes of death for adults with schizophrenia,1-4 with risk 
estimates being over eight times greater than for the general population.5 Epidemiological data 
indicate that 40-50% of adults diagnosed with schizophrenia experience suicidal thoughts,6,7 20-
50% of which make suicide attempts,8-10 and 4-13% die by suicide.1,6,7 While suicide research 
prioritizes depression and hopelessness,4,6,11,12 there is growing support for the role that 
symptoms of psychosis (e.g. hallucinations) play in risk.4,10,13-15 Further, this high suicide rate 
continues to be a major public health concern given the paucity of evidence-based interventions 
to reduce suicidality in this population.9 We propose to modify and evaluate the acceptability and 
preliminary effectiveness of Cognitive Behavioral Suicide Prevention for psychosis (CBSPp), a 
promising intervention requiring protocol and implementation modifications to increase its utility 
in community mental health (CMH).  
 
A long-term goal of our research program is to reduce premature suicidal death among 
adults with schizophrenia. Our collaborative team developed and evaluated CBSPp,11,16 one of 
few suicide interventions tailored for adults experiencing psychosis. CBSPp integrates aspects of 
validated theories of suicide, including: Schematic Appraisal Model of Suicide,17 Cry of Pain,18,19 
and Cognitive Theory of Suicide.20,21 Data show CBSPp improves global functioning and reduces 
depression, psychosis, suicidal ideation, and suicide attempt by targeting three cognitive 
components: information processing biases, appraisals, and schemas.3,11,22 
While CBSPp yields promising results, the following innovations will be pursued given 
feedback from clients and providers: 1) modify and shorten treatment; 2) develop a hybrid 
technology-assisted provider training; and, 3) develop a between-session treatment website with 
treatment reinforcing videos. Further innovations will be informed by interviews with CMH 
stakeholders for protocol and delivery modification input. 
Specific Aim 1: To modify CBSPp for clients with schizophrenia spectrum and other 
psychotic disorders (SSPD) receiving CMH services. We will develop the provider training, 
client engagement enhancers, and conduct in-depth qualitative interviews to evaluate CBSPp 
materials and delivery protocol with stakeholders, including »15 adults with SSPD and suicidal 
ideation and/or attempt (SI/A) within 3 months of screening and »10 CMH staff, providers, 
directors and leaders. Qualitative data will be analyzed and subsequently presented to a panel of 
scholarly experts in suicide, psychosis, intervention, and implementation science for input. A 
systematic process will guide CBSPp modifications, refinement of the provider training and client 
engagement enhancers, and an open pilot trial will be conducted with 8 clients and 2 providers. 
Open pilot findings and explorations of organizational impact of implementation will be discussed 
with the expert panel, followed by any additional modifications from feedback and lessons 
learned. 
Specific Aim 2: To evaluate the feasibility and preliminary effectiveness of modified 
CBSPp in comparison to services-as-usual (SAU). Adults with SSPD and SI or SA within 1 
year of screening (n=60) will be enrolled and randomized to CBSPp or SAU. A 4-wave design will 
include quantitative assessments at baseline (T1), mid-test (T2), post-test (T3), and follow-up (T4) 
with in-depth qualitative interviews at T3 for a random sample of adults in the CBSPp group 
(n=10).  Providers (n=12) will be trained to deliver CBSPp and be assessed T1-T3 to evaluate the 
implementation process, including in-depth qualitative interviews at T3. We will monitor fidelity, 
acceptability, usability, and feasibility of the modified CBSPp.  
Aim 2a: To assess whether modified CBSPp is associated with reductions in SI/A 
(primary outcome), symptoms of psychosis, depression, and emergency/hospital service 
use over time. Compared to SAU, the CBSPp group will experience significant reductions in SI/A 
(H1), symptoms of psychosis (H2), symptoms of depression (H3), and emergency/hospital service 
use (H4). 
Aim 2b: To assess whether modified CBSPp is associated with clinical (hopelessness, 

 
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defeat, and entrapment) and cognitive improvements (information processing biases, 
appraisals, and schemas) over time. Compared to SAU, the CBSPp group will experience 
significant improvements in hopelessness (H5), defeat (H6), entrapment (H7), information 
processing biases (H8), appraisals (H9), and schemas (H10).   
Exploratory Aims: To develop hypotheses for future trials, we will explore mechanisms 
for reducing SI/A and improving clinical and cognitive mechanisms (mediators) involved 
in risk for SI/A or differential response to CBSPp (moderators). We will also collect and 
explore preliminary implementation data of implementation barriers and facilitators, acceptability, 
and scalability. 
Impact: This project is in response to RFA-MH-18-706, Pilot Effectiveness Trials for 
Treatment, Preventative and Services Interventions, and follows NIMH’s strategic plan to develop 
ways to tailor existing and new interventions to optimize outcomes (3.2) and test interventions for 
effectiveness in community practice (3.3).  Successful completion of this proposal will result in a 
novel intervention that improves cognitive processes related to suicide risk, psychosis and 
depression, and reduces SI/A. Our future research will build on this work to evaluate large-scale 
CBSPp effectiveness and implementation within multiple sites of CMH. 
 
 
A. BACKGROUND 
A.1 Suicide among Adults with Schizophrenia 
Suicide is among the leading causes of death for adults with schizophrenia1-4 with risk 
estimates over eight- fold greater as compared to the general population.5 Moreover, 40-50% of 
adults with schizophrenia have suicidal thoughts,6,7 of which 20-50% make suicide attempts,8-10 
and 4-13% end their life by suicide.1,6,7  The high suicide rates among adults diagnosed with 
schizophrenia have received much attention,9 yet, evidence-based treatments are highly limited 
and suicide continues to be a major public health problem.  
 
A.2 Risk Factors for Suicide in Schizophrenia 
The relationship between schizophrenia and suicide is quite complex as researchers continue 
to examine what makes an individual with schizophrenia at risk for ending his or her life. A history 
of suicidal behaviors (ideation and/or attempt) is the strongest predictor of future behaviors.23-25 
Additional risk factors for suicide include race/ethnicity, gender, education, and poverty.  More 
specifically, risk is increased when an individual is single, male, white, socially isolated, 
unemployed, impulsive, has a history of depression, a family history of suicide, greater insight, 
treatment noncompliance, severe symptoms, and recent loss.2,3,6,10,26,27     
Among adults with schizophrenia, 22%-75% experience depressive symptoms28 including low 
mood and hopelessness, which are empirically demonstrated factors that increase risk for 
suicide.3,4,6,12,29 While research has largely focused on depression and hopelessness,3,4,6,12,29 
there is growing support for the role that positive symptoms of psychosis play in suicide risk with 
data showing delusions and auditory hallucinations increase suicidal behavior.4,10,13-15,29 Positive 
symptoms are furthermore shown to weaken social skills, increase avoidance of social contact, 
and impair development and maintenance of supports, which are known to be important protective 
factors in suicide risk.3 The importance of risk and protective factors notwithstanding, it is critical 
to examine and understand mechanisms involved in suicidal ideation and attempt.   
 
A.3 Mechanisms of Suicidal Ideation and Attempt  
Williams’ Cry of Pain (CoP)18,19 theory of suicide is grounded within ecological explanations of 
stress and defeat with the belief that feelings of extreme and uncontrollable stress are important 
and necessary components contributing to mechanisms of suicide.3,18,30,31 Components of CoP 
include: the presence of stressors, perception of stressors, cognitive biases, hopelessness, 
feelings of no rescue from others, and means for suicide.  Beyond defeat, entrapment, and 

 
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hopelessness in CoP,18,19 the Schematic Appraisals Model of Suicide (SAMS)17 suggests positive 
self-appraisals provide a key source of resilience by buffering suicidal thoughts and behaviors.   
As a modified version of CoP, the SAMS is one of few theoretical models of suicide risk that 
specifically considers symptoms of psychosis. It builds on components of CoP to provide a 
theoretical framework in which psychological mechanisms of suicidal thoughts and behaviors are 
better understood.3,17 The SAMS specifies the following 3 mechanisms shown empirically to relate 
with suicidal thoughts and behaviors: information processing biases (biases in attention, memory, 
reasoning, and problem solving), appraisals (appraisals of the current situation, past, future, and 
self), and schemas (patterns of thoughts/behaviors which categorize information about the self, 
others, and world). Nodes representing suicidal thoughts associate with representations of 
sensations, cognitions, and emotions, including a link between suicide and forms of escape.3  
 
A.4 Suicide Prevention-Focused Interventions and Schizophrenia  
Despite a larger literature suggesting individuals with schizophrenia have a heightened risk 
for suicide,9,11 there is a paucity of evidence-based interventions targeting suicide risk for this 
population. Cognitive behavioral therapy for psychosis (CBTp) has been widely used among 
individuals with schizophrenia yet has not been empirically shown to improve hopelessness, 
suicidal thoughts, or behaviors.11,32 Our team recently developed and tested the first intervention 
designed for suicidal individuals with symptoms of psychosis, the Cognitive Behavioral Suicide 
Prevention for psychosis (CBSPp),3 which is designed to identify and alter the cognitive processes 
involved in suicidal thoughts and behaviors (see B.1 CBSPp).3 While CBSPp yields promising 
results (see C.2 Preliminary Data), the treatment involves 24 individual sessions. Several 
modifications will be pursued (length of treatment, provider training, and between-session 
engagement enhancers) given feedback from clients22 and providers to improve its utility in 
community mental health (see B.2 Need to Modify CBSPp).  
Psychosis and CBT. Cognitive behavioral therapy for psychosis (CBTp) has been widely 
used among individuals with schizophrenia and aims to improve symptoms and functioning 
despite challenging experiences of positive and negative symptoms.20 CBTp incorporates 
cognitive and behavioral techniques to identify and address distressing psychotic symptoms and 
experiences, along with beliefs held about experiences, and work towards decreasing distress 
and improving quality of life. Data indicate CBSPp relates to improved positive and negative 
symptoms, functioning, and quality of life32,121,174,175,176 with meta-analyses demonstrating the 
effectiveness of CBTp in practice.32,177-181 Though there are demonstrations of effectiveness of 
CBTp among individuals with psychosis, empirical evidence has not examined outcomes of 
hopelessness, suicidal thoughts, or behaviors to date.11,32 
Suicide prevention. Suicide prevention approaches often aim to target one of the following 
strategies: strengthen economic supports (e.g., housing), increase access and delivery of 
suicide-related care (e.g., mental health care), increase protective environments (e.g., means 
restrictions), bolster connectedness and support (e.g., professional, familial, and peer support), 
increase use of problem solving and coping skills (e.g., psychosocial treatment such as CBT 
and DBT), identify and address risk (e.g., psychosocial treatment such as CBT), and 
decrease/prevent potential for harm (e.g., postvention programs182). One psychosocial 
prevention approach, and relevant to the proposed application given its theoretical 
underpinnings, Cognitive behavioral therapy for suicide prevention (CBT-SP) is a psychotherapy 
used to reduce risk for suicide attempt among individuals with mental illness (Dr. Stanley is a 
consultant in the proposed project183). CBT-SP focuses on proximal risk factors and stressors 
(e.g., relationships), safety plan development, skill building, and psychoeducation. As a 
cognitive and behavioral approach, aspects of the treatment involve a focus on hope, 
awareness of thoughts and feelings, reasons for living, alternative ways of thinking and 
behaving, and distress tolerance. Data show support of CBT-SP improving suicide-related 
outcomes with a study by Brown and colleagues184 indicating CBT-SP treatment (in 10 

 
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outpatient sessions) resulted in a 50% reduction in the likelihood of a suicide re-attempt among 
adults who initially presented in an emergency department after an attempt as compared to 
treatment as usual. Though there are demonstrations of CBT-SP effectiveness among 
individuals with mental illness, empirical evidence has not examined this intervention among 
individuals with psychosis. 
Interventions to address suicide among individuals with psychosis. Suicide is among 
the leading causes of death for adults with schizophrenia1-4 with risk estimates over eight- fold 
greater as compared to the general population.5 Despite knowledge of this public health 
problem and evidence for the contributions of psychosis symptomatology in increased risk for 
suicide thoughts and behaviors,4,14,29,185-189 effective evidence-based interventions aimed 
towards suicide prevention in this population are lacking.9,11,190 Specifically, few controlled trials 
have been conducted investigating the effectiveness of psychosocial (i.e., nonpharmacological 
therapeutic interventions that address the psychological, social, personal, relational, or 
vocational problems associated with schizophrenia spectrum disorders) interventions for 
addressing suicide ideation, behavior, and death among participants with schizophrenia 
spectrum disorders.190  
Tarrier and colleagues16 conducted a systematic review and meta-analysis to examine 
cognitive-behavioral interventions to reduce suicidal behavior (suicide ideation, plan, attempt, or 
suicide death) among adolescents and adults in different diagnostic groups. A significant effect 
was found in 28 studies for cognitive-behavioral interventions in reducing suicidal thoughts and 
behavior; however, the majority of samples did not include participants with psychosis. 
Bornheimer and colleagues190 recently conducted a systematic review and meta-analysis to 
evaluate the effectiveness of psychosocial interventions in reducing suicide ideation, plan, 
attempt, and death among individuals with psychotic symptoms. The psychosocial interventions 
examined in 11 studies, with 14 effect sizes (N=4,829 participants), had a significant impact on 
reducing suicide ideation, plan, attempt, and death in this population. In examinations of 
psychosocial treatment types, we observed that most participants received either a mixture of 
therapeutic (e.g., CBT) and supportive (e.g., case management) interventions (n=8) or 
therapeutic interventions (n=7), with cognitive and behavioral being most often delivered (n=4). 
Importantly, while cognitive and behavioral approached were used in 4 identified studies within 
this schizophrenia spectrum population, one used CBSPp (trial 13) and the remainder indicated 
use of CBT tools and techniques without a manual. Not only did we note a variety of treatment 
modalities for suicidal intervention among participants with psychosis, we also observed a wide 
range in the number of sessions delivered to participants—6 weeks to 5 years—suggesting that 
the field is testing a variety of lengths of treatment.  
 
 
B. RESEARCH DESIGN 
We aim to modify, evaluate the feasibility and acceptability, and assess the preliminary 
effectiveness of a modified CBSPp administered to clients with SSPD and SI/A in CMH. By using 
the stage model of treatment development as a guiding framework,55 we propose to: Aim 1) review 
qualitative data from stakeholders (clients, staff, providers, directors, and leaders of CMH) with 
input from an expert panel and an open pilot trial to guide modifications of CBSPp; and, Aim 2) 
conduct a feasibility and preliminary effectiveness trial of modified CBSPp. 
 
B.1 Study Site  
The study will take place at Washtenaw County Community Mental Health (WCCMH). 
WCCMH provides mental health services to adults with severe mental illness and 
developmental disability. They are the primary CMH provider in Washtenaw County, and 
represent a public mental health system encompassing the diversity of Michigan (race, ethnicity, 
socioeconomic status, organizational services, insurance/payment types). WCCMH offers a 

 
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breadth of programs including crisis residential services, case management, outpatient mental 
health, medication management, assertive community treatment, and more. 
 
B.2 Study Participants and Procedures 
Client participants. Includes adult clients 18 and older who have attended/engaged with 
any services offered at WCCMH within 6 months of contact, English-speaking, have at least a 
6th grade reading level measured by the Wide Range Achievement Test 5 (WRAT-5), 
Schizophrenia spectrum or other psychotic disorder (SSPD) based upon The Mini International 
Neuropsychiatric Interview (MINI), and SI or SA within 1 year of screening based upon the 
Columbia-Suicide Severity Rating Scale (C-SSRS). Exclusions involve the following: requiring 
emergency care (e.g. imminent plan to harm self) as determined by trained research staff 
administering the Columbia-Suicide Severity Rating Scale (C-SSRS), or determined to not be 
appropriate for behavioral treatment according to own judgment in consultation with a treating 
clinician at the research site (WCCMH). Clients also must have the capacity (cognitive capacity) 
to participate and both case managers and providers delivering treatment will evaluate this.  We 
expect the following time to complete study activities: 
 
 
B.3 Recruitment, Screening, and Enrollment 
Client participants. Designated WCCMH personnel will identify client participants who may 
meet criteria for study inclusion based upon DSM SSPD diagnosis and SI within or SA within 1 
year of screening per CMH documentation. Such documentation is internal at CMH and could 
be considered as personnel assess if a client may meet criteria and suggest they be formally 
screened by the research team. Case managers will be notified if their client(s) meet criteria and 
will be prepared with instructions by the research team on how to present the study given 
clients’ potential eligibility. Clients who are interested to learn more will be instructed to either: 1) 
reach out to research staff (RS) via phone, or, 2) give consent for the case manager to give the 
potential participant’s contact information to RS so they can be contacted via phone and learn of 
next steps (eligibility, consent, enrollment, assessment). RS will begin this process while in the 
initial contact or schedule a meeting/conversation with clients who are interested in learning 
more about the at WCCMH (coordinating with an already scheduled appointment with a 
provider) either in-person at WCCMH or via zoom (virtually). In this meeting/conversation 
(phone or zoom), RS will describe the study and review the informed consent form so the client 
is prepared to view it on their own. At the end of this ‘informational meeting,’ the client will be 
given the link to provide informed consent on their own (via REDCap).   If consent is obtained, 
the research team will see completion of consent in REDCap and follow up with the client via 
the contact information they provided in the consent form to schedule a screening assessment.  
Also, the research staff member will complete a post-consent form in REDCap to document 
their initial contact, explanation of study/consent form, and follow-up with client if consented to 
schedule screening assessment. The screening tool will be administered in the scheduled 
screening assessment to determine eligibility for enrollment.  Screening will involve use of The 
Mini International Neuropsychiatric Interview (MINI)148 to confirm a SSPD based upon criteria of 
the DSM-5.149 A 1-year history of SI/A will be confirmed using the C-SSRS.141 Lastly, the Wide 
Range Achievement Test 5 (WRAT-5)150 will be administered to confirm at least a 6th grade 
reading level in English given use of CBSPp materials.   
 
B.4 Procedures After Enrollment 
Clients participating in the RCT of Aim 2 will: 
1. Complete a 1.5-hour survey following screening/enrollment, including questions about 
personal characteristics, symptoms of psychosis, depression, suicide thoughts and 
suicide attempt.  

 
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2. Be randomized to either receive the treatment (CBSPp) or be in the SAU group (receive 
standard services at CMH already engaged with) 
3. For CBSPp group only: Attend weekly one-on-one therapy sessions with a trained 
provider for up to 10 weeks. Our research staff will set this up and therapy sessions will 
either take place at Washtenaw County Community Mental health or virtually via Zoom. 
Therapy sessions will be focused on improving thoughts of suicide and preventing 
suicide attempt. All therapy sessions will be audio recorded so we can check that 
therapists are correctly giving this treatment.  
4. Complete a 1.5-hour assessment approximately in 1-month, 3-months, and 5-months. 
Assessment surveys will be focused on experiences with symptoms of psychosis, 
depression, suicide thoughts and suicide attempt.  
5. Use a treatment website that we will provide between therapy sessions with short videos 
to help you practice skills you will learn in treatment.  
6. For CBSPp group only: A random selection of clients in the treatment group will attend a 
30 minute interview with research staff at the end of the study which will be audio 
recorded and include questions about experiences in the study.   
 
 
B.5.A Cognitive Behavioral Suicide Prevention for psychosis (CBSPp). Clients randomized 
to the treatment group (CBSPp) will attend 10 weekly individual therapy sessions with a trained 
provider in addition to standard WCCMH care (e.g. individual treatment, family services, case 
management, and medication management). Sessions will be audiotaped and providers will 
administer the C-SSRS141 to asses for SI/A in each visit for risk management.  Participants in 
the services as usual group (SAU) will receive SI/A screening as part of WCCMH’s standard 
protocol.  
 
CBSPp is structured to begin 
with 
an 
assessment 
phase 
followed by a treatment phase in 
which numerous techniques and 
strategies are used to address 
information processing biases, 
negative appraisals, and suicide 
schemas. 
Assessment 
phase 
sessions involve explorations of 
psychiatric symptoms, history of 
suicide ideation and attempt, 
family history of psychiatric illness, 
recent stressful life events, risk for suicide, recovery goals, protective factors, inhibitory factors, 
coping skills, social support and sense of defeat, entrapment, and hopelessness; all of which will 
inform the treatment delivery.  Throughout assessment, the clinician begins to identify suicide-
related information processing biases, appraisals, and schemas. After assessment, techniques 
and strategies are used in-session and assigned in homework to address information processing 
biases, negative appraisals, and suicide schemas.  Exits from suicide schema occur as evidence 
of resilience and the cognitive processes involved in these exits are identified and reinforced in 
the treatment process.3 While CBSPp is a promising intervention with encouraging preliminary 
data, it requires protocol and implementation modifications to increase its utility in community 
mental health settings.  
 
B.5.B Services as usual (SAU). Standard outpatient care will serve as the comparison condition, 
allowing us to test effectiveness-based hypotheses (Aim 2a and 2b) comparing CBSPp to SAU. 

 
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As for management of suicide ideation and attempt in services-as-usual, current WCCMH 
practices involve safety assessment (which may result in referral for emergency services 
and/or hospitalization) and potential access to greater intensity of services, based upon 
psychiatric assessment and clinical judgment of providers. These changes in services may 
include more: 1) frequent psychiatry and/or therapy appointments; 2) outreach phone calls 
with peer support; and, 3) calls or visits with case managers for support, continued evaluation 
of risk, and crisis/safety planning). 
 
B.5.C Engagement enhancers 
Aim 2 Engagement enhancers for clients in treatment group. Engagement 
enhancement for clients in the CBSPp group include treatment boosting text messages each 
week, a link to watch a 1-2 minute video to boost treatment each week, and access to a 
treatment website with psychoeducation, supportive statements (similar to boosting text 
messages), and embedded weekly treatment videos.  
 
B.5.D Assessment 
Aim 2 Qualitative assessment. We will systematically evaluate the CBSPp treatment and 
its implementation in qualitative in depth interviews. A random subset of participants in the 
treatment group will be selected to participate in interviews (approximately 10-12) and 10 staff, 
directors, and leaders at CMH will be scheduled to attend an interview with research staff (30 
min) and respond to questions about perceptions of the treatment, its implementation, and 
potential scalability in community mental health. The interview will be audio recorded for 
research purposes. 
 
ASSESSMENT TIMING (T1-T4) 
 
● T1 (baseline assessment): completed following consent for providers and following 
screener for clients (if eligible) 
● T2 (mid assessment): completed 30 days after baseline for SAU client participants and 
30 days after treatment starts for CBSPp client participants (intended to be around 
session 5 of treatment).  
● T3 (post assessment): completed 90 days after baseline for SAU client participants and 
90 days after treatment starts for CBSPp client participants (intended to be around 
session 10 of treatment). 
● T4 (follow up assessment): completed 150 days after baseline for SAU client 
participants and 60 days after treatment ends for CBSPp client participants (intended to 
be 2 months after treatment is completed).  
●  
Table 3: Measurement 
Construct 
Instrument(s) 
Time  
Reporter 
Aim 2a:  To assess whether modified CBSPp is associated with reductions in SI/A (primary outcome), 
symptoms of psychosis, depression, and service use over time. 
Suicide ideation  
Beck Scale for Suicide Ideation (BSI)156 
T1,T2,T3,T
4 
CT 
Suicide attempt 
Columbia Suicide Severity Rating Scale (C-SSRS) 
T1,T2,T3,T
4 
CT 
Psychosis  
Positive and Negative Syndrome Scale (PANSS)158 
T1,T2,T3,T
4 
CT 
Depression 
Calgary Depression Rating Scale (CDRS)159,160 
T1,T2,T3,T
4 
CT 

 
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B.7 Additional Procedural Information 
b.7.a Service use tracking and diagnostic information. Service use will be tracked in an 
electronic medical record and designated staff of WCCMH will access this information and de-
identify it for linkage with collected participant data in the study (from assessments). Participants 
will be linked to their study ID number in the process of de-identifying data for the research team. 
Clinical data that will be obtained from the participant’s CMH medical record, as described in the 
consent, will include attendance and service use at CMH, frequency and nature of emergency 
room visit documentation, and frequency and nature of inpatient hospitalization documentation. 
More specifically, details of CMH services (frequency and duration of visits both scheduled and 
attended with therapist, psychiatrist, case manager, assertive community treatment team, and 
crisis residential service team) and community services (emergency room visits and inpatient 
hospitalizations) engaged in. In addition, diagnostic information will be collected from the 
electronic medical record within the past year (e.g., depressive disorder, diabetes, etc.) 
 
B.7.b Provider CBSPp supervision. The PI and Dr. Himle (including consultation with Dr. 
Tarrier as needed) will supervise provider delivery of CBSPp through group videoconference (2-
4 hours per month) and will be available as needed for clinical issues that may arise (see 
Protection of Human Subjects). Supervision will focus on CBSPp delivery, review of sessions, 
clinical care, fidelity, and implementation. Imbedded in supervision will also be identification and 
management of adverse events as a refresher to reinforce the study’s safety protocol.   
 
B.7.c Provider competence and CBSPp fidelity. Throughout the Aim 2 RCT, providers will 
self-rate fidelity using a checklist after each session. Also, 20% of audiotaped sessions will be 
randomly selected for rating. The fidelity rating scale has been developed and will be used. 
 
B.7.d Feasibility. We will track the number of: 1) calls made and received with potential 
participants, 2) signed informed consents, and 3) eligible participants after screening.  We will 
determine feasibility of CBSPp by: 1) session attendance, 2) CMH service use, and 3) fidelity 
ratings. An element of feasibility is the ability to recruit participants in the proposed timeframe.  
 
B.7.e Retention, tracking, and attrition. Our research team has substantial experience in 
recruiting and tracking participants and providers in CMH clinics and we also have established a 
strong working relationship with WCCMH. Specific approaches include: 1) reminder calls one day 
prior to visits; 2) provider contact with clients who miss sessions/appointments to ascertain 
reasons for absence, barriers to attendance, and engage in troubleshooting efforts); 3) a 
Service use 
Electronic medical records 
T1,T2,T3,T
4 
PV 
Aim 2b: To assess whether modified CBSPp is associated with clinical and cognitive improvements over 
time. 
Clinical  
 
 
 
Hopelessness 
Beck Hopelessness Scale (BHS)161 
T1,T2,T3,T
4 
CT 
Defeat 
Defeat Scale162 
T1,T2,T3,T
4 
CT 
Entrapment 
Entrapment Scale162 
T1,T2,T3,T
4 
CT 
Key: T1 = baseline; T2= mid-test; T3= post-test; O= ongoing; CT= clients; PV= providers, RS= research staff 
aSuicide ideation and attempt measures will yield a score on a continuous scale and will be additionally 
recoded into dichotomous variables to represent the incidence of ideation or attempt in analyses 
bUsed in prior NIMH funded research projects of investigative team 

 
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participant tracking system; and, 4) client participation will be encouraged through compensation 
for all assessments.  
To mitigate risk to participants who drop out of the CMH system during their participation in 
the research, we will do the following: 
1. CMH providers will be trained in client retention 
2. If the participant contacts the study team, the study team will work with the participant 
to try and re-engage them with CMH 
3. If the participant contacts the study team, the study team will work with CMH to re-
establish contact with the subject. 
4. If re-engagement isn’t possible, the study team will work with CMH to provide 
alternate referral sources for the participant. 
 
B.7.f Contamination. Providers will work exclusively with clients in the treatment (CBSPp) or 
comparison (SAU) groups at WCCMH in order to protect against contamination of CBSPp 
principles into the SAU group.  We acknowledge that contamination can occur on various levels 
and will follow prevention recommendations of Magill and colleagues (2019). In particular, 
providers will be instructed throughout the hybrid-training and ongoing supervision not to talk 
about details of their clinical work with each other and we will use supervision and taping of 
sessions to monitor potential contamination. Also, clients will be periodically asked and reminded 
not to share contents of intervention with each other. If it is identified that contamination has 
occurred, our leadership team (PI and Co-Is) will investigate where contamination has occurred 
and discuss removal of certain provider(s) and/or client participant(s) from the study or analyses.  
 
B.7.g Adverse events. WCCMH will have clinical staff available during the time of all scheduled 
screenings, assessments, and CBSPp sessions to assess mental health and risk of harm to self 
or others if needed during the study.  Dr. Florence (WCCMH Medical Director), Dr. Bornheimer 
(PI), Dr. Himle (Co-I), Dr. King (Co-I), and Dr. Taylor (Co-I) will provide clinical oversight for 
emergent clinical issues that may arise. Further, mandated reporting will be carefully 
implemented, and all participants will be aware during consenting that clinical information 
indicating and acute risk for suicide will be shared with their respective provider.   
 
B.7.h Client Participant Capacity (cognitive) 
Client participants’ capacity to consent will be assessed prior to participation as well as 
throughout the study by therapy providers and case managers. The following will be followed: 
1. Case managers are trained on assessing client competency and correspond with 
treating psychiatrist per CMH protocol when competency is of concern. 
2. If a potential participant is found not to be competent prior to participation (before 
consent and enrollment), the case manager will find other avenues of treatment within 
CMH. 
3. Should a subject be found not to be competent after participation has begun, their 
participation in the research will end. Case managers will find other avenues of 
treatment within CMH which are appropriate for the client and their capacity. Ending 
participation in the study will have no impact on service delivery at CMH.   
 
B.7.i DROPOUT. Any participant assigned to CBSPp who fails to attend at least 6 sessions 
will be coded as a non-completer, consistent with prior use of 60% completion cutoff within 
the research team’s NIH funded CBT trials (Himle et al., 2019). Non-completers will be 
compared to completers on demographic and clinical characteristics, including suicidality to 
examine patterns predicting treatment non-completion. In addition, any participant who 
leaves treatment will be contacted in an attempt to collect the scheduled assessments. We 

 
10 
will also examine predictors of drop-out from the study for any participants who failed to 
provide assessment data for all four time-points versus those who provided all assessment 
data. 
 
 
B.8 Client Incentives 
 
Below describes payment for each of the 5 steps: 
 
1. Screening assessment to determine eligibility: $30 
 
If eligible:  
 
2. Baseline survey assessment: $65 
3. 1-month survey assessment: $50 
4. 3-month survey assessment: $50 
5. 5-months survey assessment: $55 
 
If all 5 steps above are completed, the total amount a participant will receive is $250.  
 
If a participant in the treatment group is selected and agree to the 30-minute interview with 
research staff at the end of the study (for those in the treatment group), they will get an 
additional $30 gift card or check ($280 total). 
 
 
Clients randomized to treatment group: Maximum of $310 (see details above) 
 
 
Clients randomized to SAU group: Maximum of $280 (see details above) 
 
 
High Risk and Management 
 
Risk status will be formally determined and recorded at the T1-T4 quantitative assessments. 
There will not be an assessment of suicide risk conducted by research staff during the 
treatment sessions for participants receiving CBSPp or SAU, as providers conduct a 
comprehensive risk assessment as part of standard clinical protocol.  Steps are outlined below 
to assess for high risk, manage the high risk, and engage in the action plan if high risk is 
present. 
 
Definition of High Risk 
The following 4 questions must be asked to a client with potential of high risk. Clients will be 
categorized as High Risk if they meet one or more of the criteria listed below: 
 
(1) Current active suicidal ideation with method or higher on the C-SSRS, defined as a “yes” to 
#3, 4, or 5 during the last week 
(2) An actual, interrupted, or aborted suicide attempt since last assessment  
(3) A verbal statement of clear suicidal intent or a plan to commit suicide 
(4) Clinical judgment that combination of current risk factors places the participant at 
high risk  

 
11 
 
 
MANAGEMENT OF HIGH RISK STATUS 
1.  Procedures 
If a client meets High Risk criteria during research staff contact (meeting one or more of the 
criteria above), the Action Plan will be followed and the Project Coordinators (Nick Brdar and 
Maura Campbell) and clinical supervisor (Dr. Bornheimer) will be notified. 
 
 
If a client has been identified as High Risk, (according to criteria specified) the project staff 
member will ask the following additional questions. These questions will be helpful in 
determining next steps. Responses are recorded in the Risk Protection Action Plan Excel 
Sheet which will be regularly maintained and updated in the study Dropbox folder. 
 
 
Additional questions to ask if potentially high-risk per the 4 initial questions above:  
 
In the last week... 
- Has the participant experienced suicidal ideation? 
- Has the participant thought of a plan for how to kill self? 
- Has there been alcohol or drug use? 
 
And… 
- Has the participant talked about their past week suicidal ideation or behaviors with a provider? 
-How confident is the participant in keeping themselves safe today (0-10 scale, 10 being very 
safe)? 
- Is the participant currently in treatment with a psychiatrist, psychologist or social worker? If 
yes, when was the most recent appointment and when is the next appointment? 
- Does the participant have access to a firearm?  
Script: “Do you have a firearm in your home or access to a firearm?” If Yes, “We have 
learned that the presence of a firearm in the home or the availability of a firearm is a risk 
factor for suicide. We strongly recommend that any firearm be removed from the home 
as soon as possible. Is there a friend or family member who could do this for you?” 
-What protective factors does the participant have in place (contact with friends, pets, 
community)? 
 
 
 
 
2. Action Plan 
 
 
The study site (WCCMH) will have clinical staff available during the time of all scheduled 
screening, assessment, and CBSPp delivery to assess mental health and risk of harm to self or 
others if needed. Leadership team includes Dr. Florence (Medical Director of WCCMH), Dr. 
Bornheimer (PI), Dr. Himle (Co-I), Dr. Cheryl King (Co-I), Dr. Stephan Taylor (Co-I), Nick Brdar 
(coordinator), Maura Campbell (clinial coordinator), Katie Hoener (CMH director), Melisa Tasker 
(CMH director), and Krista DeWeese (CMH director). Leadership team will be involved in clinical 
issues requiring assessment of mental health and risk to harm self or others after RS evaluation, 
CBSPp sessions with providers, or interaction with site staff. If trained RS, providers, or site staff 
observe or assess a participant to be acutely symptomatic or having acute risk of harm to self or 

 
12 
others, then research staff will follow the following policies (informed by existing WCCMH 
procedures): 
 
• 
Inform the participant you will need to consult with the supervising clinician and 
remain with them as you navigate the next steps. The participant can be told that this 
is a requirement of the study whenever there is a concern about a participant’s level 
of risk and possibility of self-harm or suicide.  
• 
Carry out the high-risk protocol (series of 4 questions above) to determine if there is 
potential high risk.  If one of the 4 questions are yes, continue with additional high-
risk questions that are italicized and document responses.  
• 
Contact Nick Brdar (Project Coordinator) and report steps taken from the high-risk 
protocol. 
• 
Contact Maura Campbell (clinical coordinator on site at WCCMH) if this is occurring at 
CMH in-person.  
• 
If a coordinator (Nick or Maura) determines CMH staff should be consulted with to 
determine risk, contact any of the following: a) client’s case manager or provider at 
CMH, or b) CMH director of the leadership team: Katie Hoener (CMH director), Melisa 
Tasker (CMH director), and Krista DeWeese (CMH director). 
• 
Contact the clinical supervisor of the leadership team to discuss risk level and next 
steps (Dr. Bornheimer). Dr. Bornheimer will conduct a suicide risk assessment or 
psychosis symptom assessment if more information is needed to inform next steps. 
Dr. Bornheimer will also consult as needed with other members of the leadership team 
including CMH directors (especially if they have been involved as a prior step).  
• 
The clinical supervisor will make a determination about risk level and appropriate next 
steps including need for follow-up evaluation, connecting with CMH crisis services 
(including the 24/7 mobile crisis team: 734-544-3050), or calling 911.  The clinical 
supervisor will inform both coordinators and any involved research staff about this 
decision.  
• 
If determined to be needed, the research staff or a leadership team member will call 
911. 
• 
In the case of acute suicidal ideation/intent, research staff must watch the participant 
until Police/Security/Ambulance arrives.  
• 
If in person, call the WCCMH building security and inform them that Police and/or 
Ambulance was contacted.  The security officer from the building will come to specific 
location within WCCMH, if needed.  Security should arrive to facilitate within 10 
minutes and help the research staff while Police and/or Ambulance arrive. 
• 
A coordinator (Nick or Maura) will provide an oral report of the event and the clinical 
supervisor’s recommendation to the police/security.  
• 
Call ED to alert that a participant from the study is on the way and provide them with 
all necessary information. 
• 
Follow-up with crisis team/on call resident to give information about the participant.  
• 
Document use of the high-risk protocol in the Risk Protection Action Plan Excel 
Sheet (in Dropbox) regardless of the outcome.  This means, we document every use 
of this protocol involving asking questions even if risk is determined to be low and the 
action plan doesn’t unfold to consultations and linkage to care. 
 
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