Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive-behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 1 Open Pilot Trial to Test Modified Treatment and Measurement Prior to Aim 2 RCT (Registered Separately)
Phase: NA
Conditions: Suicide, Psychosis
Sponsor: University of Michigan

 
0 
Identifiers: NCT04689867 
Unique Protocol ID: HUM00152247 
Secondary IDs: R34MH123609 
 
Title: Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1 
 
Contents: Aim 1 Open Pilot Study Protocol and Statistical Analysis Plan (Approved for use by 
IRB on 12/10/2021) 
 
Note: Any mention of Aim 1 stakeholder phase or Aim 2 RCT is informational  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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/A within 3 months 
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 T4 for a random sample of adults in the CBSPp group 
(n=10).  Providers (n=8) will be trained to deliver CBSPp and be assessed T1-T4 to evaluate the 
implementation process, including in-depth qualitative interviews at T4. 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 

 
2 
(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, 
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. 
 
 
 
BACKGROUND 
 
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.  
 
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.   

 
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 
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  
 
RESEARCH DESIGN FOR AIM 1 OPEN PILOT (not including stakeholder phase or RCT) 
 
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 
breadth of programs including crisis residential services, case management, outpatient mental 
health, medication management, assertive community treatment, and more. 
 
Study Participants and Procedures  
 
Client participants. Includes adults 18 to 65 years of age clients 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 4 (WRAT-4), Schizophrenia spectrum or other psychotic disorder (SSPD) based upon The 
Mini International Neuropsychiatric Interview (MINI), and Suicidal ideation or attempt (SI/A) 
within 3 months of assessment 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: 
• 
Clients in open trail of Aim 1: We expect the amount of time to be 20.5 hours total: 30 
minute screener, weekly one-on-one therapy sessions with a trained provider for up 
to 10 weeks (10 hours maximum), use of treatment website with treatment 
reinforcing videos between treatment sessions during the 10 weeks of treatment (5 
hours approximately), 1-hour surveys at 4 time-points (4 hours total), and an 
interview at the end of study (1 hour). 

 
4 
Recruitment, Screening, and Enrollment 
 
Client participants. Designated WCCMH personnel will identify client participants who 
meet criteria for study inclusion based upon DSM SSPD diagnosis and endorsement of suicide 
ideation and/or attempt within 3 months per documentation of the C-SSRS. Case managers will 
be notified if their client(s) meet criteria and will be prepared with instructions by the research 
team (see scripts) 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 schedule an in-person meeting with clients who are 
interested in learning more about the at WCCMH (coordinating with an already scheduled 
appointment with a provider). In this meeting, RS will describe the study (see scripts) and review 
the informed consent form.  If consent is obtained, the screening tool will be administered to 
determine eligibility for enrollment (approximately 15 minutes long).  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 3-month history of SI/A will be confirmed using the C-SSRS.141 Lastly, 
the Wide Range Achievement Test 4 (WRAT-4)150 will be administered to confirm at least a 6th 
grade reading level in English given use of CBSPp materials.   
 
Procedures After Enrollment 
 
Client participants in open trial of Aim 1. Clients participating in the open trial of Aim 1 
will: 
1. Complete a 1-hour survey following enrollment (not a separate visit), including questions 
about personal characteristics, symptoms of psychosis, depression, suicide thoughts 
and suicide attempt.  
2. Attend weekly one-on-one therapy sessions with a trained provider for up to 10 weeks. 
Our research staff will set this and therapy sessions will take place at Washtenaw 
County Community Mental health at your convenience. 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.  
3. Complete a 1-hour survey approximately in 1-month, 3-months, and 5-months. Surveys 
will be focused on experiences with symptoms of psychosis, depression, suicide 
thoughts and suicide attempt.  
4. Use a treatment website that we will provide between therapy sessions with short videos 
to help you practice skills you will learn in treatment.  
5. Attend a 1-hour interview with research staff at the end of the study which will be audio 
recorded and include questions about experiences in the study.   
 
If client participants refuse to participate after determined to be eligible, enrolling in the 
study, being assigned to a provider, and/or starting study activities (surveys and/or 
treatment), they will be removed from the study and thanked for their time. 
 
If a client participant leaves WCCMH services (e.g., moves, ends services, switches to 
different service provider) during the study, their participation in the study will end.  
 
Client participant attendance will be tracked as one of our goals is to learn more about 
acceptability and feasibility of the intervention. While 10 sessions are what providers will be 
trained to deliver, clients may choose not to attend all sessions.  It is important to note that 

 
5 
there will be no consequences for not attending sessions; participants can remain as active 
as they choose to be with treatment and survey completion.   
 
If a provider leaves during the study and/or during the process of delivering CBSPp with a 
client participant, we will re-assign the client(s) to a different therapist who has been trained 
in CBSPp.  If needed, we train additional providers in preparation for resuming treatment 
with client participants whose previous provider left.  
 
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp). Clients in the Aim 1 Open 
Pilot Trial treatment group (CBSPp) will attend individual therapy sessions with a trained 
provider (10 weeks/10 sessions) 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.  
CBSPp was developed as a 24-week series of individual therapy sessions with a clinician in a 
structured protocol, and modified to be 10 weeks in Aim 1 of this study (stakeholder phase of 
Aim 1 prior to open pilot trial). Cognitive and behavioral techniques3 are implemented 
systematically to address cognitive (information processing biases, appraisals, and schemas) 
components from the SAMS theoretical model (see Table 1).17 The goal is to develop broad-
minded attention, balanced appraisals, and alternative schemas about the self, world, and the 
future resulting in exit from suicide schemas.  The three cognitive components of SAMS have 
been tested empirically, though not within a CBSPp trial.11,22  
 
 
 
 
 
 
 
 
 
 
 
 
 
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.  
 
 
 

 
6 
Assessment 
 
Aim 1 Open pilot trial Quantitative data. Clients will complete comprehensive 
assessments at baseline (T1), mid-test (midpoint of total CBSPp sessions; T2), post-test 
(endpoint of CBSPp sessions;T3), and follow-up (3 months after CBSPp session endpoint;T4). 
Measurement shown below in Table 3. 
 
Aim 1 Open Pilot trial Qualitative assessment. We will systematically evaluate the 
modified CBSPp using in-depth face-to-face qualitative interviews with all clients in the open 
pilot trial. Topics will focus on: 1) perceptions about their experience receiving the treatment, 
feedback regarding treatment impact and observed mental health outcomes, experiences with 
the added engagement enhancers, and factors impacting possible sustainability of maintaining 
the treatment at community mental health over time. 
 
Statistical Design and Analysis 
 
Aim 1 open pilot quantitative data analysis. A focus of Aim 1’s open pilot is to implement 
the CBSPp treatment and assessments in preparation for potential modifications prior to Aim 2. 
We will preliminarily explore outcomes (SI/A, symptoms of psychosis, depression, 
emergency/hospital service use, hopelessness, defeat, entrapment, information processing 
biases, appraisals, and schemas) in preparation for Aim 2.  Given the open pilot is small in size 
(n=8 clients), we don’t have power to detect changes over time in Aim 1. Therefore, quantitative 
data will be examined at the univariate and bivariate level for distributions and associations 
between variables.  Measures of dispersion (mean, standard deviation, variance, range) and 
distribution (kurtosis, skewness) will be computed. Scatterplots will be generated to examine 
linearity and outliers for bivariate relationships using Chi-Square analysis (categorical variables), 
analysis of variance (ANOVA; scaled variables), and paired samples t-tests (continuous 
variables) in SPSS28. 
 
Table 3: Measurement (note: this is measurement for testing within Aim 2, though all measurement will be 
tested in Aim 1’s open pilot trial) 
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. 
SI/A 
Columbia Suicide Severity Rating Scale (CSSRS)129 
T1,T2,T3,T4 
CT, RS score 
Psychosis  
Positive and Negative Syndrome Scale (PANSS)158 
T1,T2,T3,T4 
CT, RS score 
Depression 
Calgary Depression Rating Scale (CDRS)159,160 
T1,T2,T3,T4 
CT, RS score 
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,T4 
CT 
Defeat 
Defeat Scale162 
T1,T2,T3,T4 
CT 
Entrapment 
Entrapment Scale162 
T1,T2,T3,T4 
CT 
Social support 
Quality of Life163 
T1,T2,T3,T4 
CT 
Coping 
Coping in Stressful Situations Inventory (CSSI)164 
T1,T2,T3,T4 
CT 
Cognitive  
 
 
 
Information 
processing biases 
Modified Stroop task165,166 
T1,T2,T3,T4 
CT 
Appraisals 
Resilience Appraisals Scale (RAS)167 
Reappraisal Subscale of Emotion Regulation 
Questionnaire (ERQ)168 
T1,T2,T3,T4 
CT 
Schemas 
Suicide Concept Sort Task (SCT)155 
T1,T2,T3,T4 
CT 
Key: T1 = baseline; T2= mid-test; T3= post-test; O= ongoing; CT= clients; RS score = research staff score 
ratings as this is a clinical interview and not a self-report measure. 

 
7 
Aim 1 open pilot qualitative data analysis. Qualitative in-depth interviews data were 
transcribed and coded using Dedoose. Transcripts were independently coded by two research 
assistants (RAs) in preparation for codebook development using an open coding technique to 
generate themes across qualitative questions (Saldana, 2016). Grounded theory methods were 
utilized for analysis (Charmaz, 2014).  The PI met with both RAs to discuss emerging themes 
after a first round of coding and agreed upon a final codebook.  Both RAs completed a second 
round of coding using the final codebook and the PI resolved any disagreements to achieve 
inter-coder consistency. Themes were ultimately organized into a final framework and the 
following strategies for rigor (Padgett, 2016) were included in the study: 1) triangulation, 
specifically analytic triangulation (more than one coder), 2) audit trail, and 3) member checking 
with stakeholder participants (i.e., in provider, peer, and client meetings). 
 
Additional Procedural Information 
Service use tracking. 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.  
 
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.   
 
Provider competence and CBSPp fidelity. Throughout the open pilot, providers will self-rate 
fidelity using a checklist after each session. Also, 20% of audiotaped sessions will be randomly 
selected for blind rating by two established experts currently assessing CBT fidelity within Dr. 
Himle’s NIMH-funded projects.  
 
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.  
 
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. 

 
8 
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.   
 
 
Risk 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 licensed clinicians conduct a 
comprehensive risk assessment as part of standard clinical protocol.   
 
Definition 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  
 
Management of Risk Status 
 
1.  Procedures 
If a client meets High Risk criteria during research staff contact, the Action Plan will be 
followed and the senior on-call clinician will be notified. 
 
If a client has been identified as High Risk, (according to criteria specified) the project staff 
member asks the following additional questions. These questions will be helpful in 
determining next steps. Responses are recorded in an Action Plan form. 
 
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? 
- Does the participant have access to a firearm?  
- 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? 
 
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. Dr. Florence (Medical Director of WCCMH) and Dr. Bornheimer (PI), with input 

 
9 
and support as needed by Dr. Himle (Co-I), Dr. Cheryl King (Co-I), and Dr. Stephan Taylor (Co-
I), will be involved in all 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 others, then they will follow the following policies (informed by 
existing WCCMH procedures): 
 
• Alert the Project Coordinator (provide with relevant information). 
• Alert Dr. Florence (Medical Director of WCCMH), Dr. Bornheimer (PI), and Dr. Himle 
(Co-I) about the problem (provide demographics and relevant medical information such 
as suicidal, homicidal ideation/intent, diagnosis, presenting acute symptoms, medical 
condition). Drs. Bornheimer and Himle will consult with Drs. King and Taylor (Co-I) as 
needed. 
• If expressing suicidal ideation with a plan and/or reporting a recent attempt, Dr. 
Florence (Medical Director of WCCMH), Dr. Bornheimer (PI), and Dr. Himle (Co-I), or 
trained RS will administer the C-SSRS (see above description in A.1.a Inclusion and 
Exclusion Criteria). Dr. Florence will lead the decision-making of who will administer the 
C-SSRS in a given situation. 
• If escalation in symptoms not including suicidal ideation and/or attempt, Dr. Florence 
(Medical Director of WCCMH), Dr. Bornheimer (PI), and Dr. Himle (Co-I), or trained RS 
will administer the 18-item Brief Psychiatric Rating Scale (BPRS). Dr. Florence will lead 
the decision-making of who will administer the C-SSRS. A rating of 4 on the BPRS 
reflects functional impairment for: hostility, excitement, grandiosity, tension, 
mannerisms & posturing, motor retardation, uncooperativeness, blunted affect, blunted 
affect, conceptual disorganization, and disorientation; and a rating of 5 on the BPRS 
reflects functional impairment for: somatic concern, anxiety, depressive mood, guilt 
feelings, suspiciousness, hallucinatory behavior, and unusual thought content. 
• Contact the primary treating WCCMH mental health provider (e.g., psychiatrist) via 
page or phone number (provided during consent) to be in touch with Dr. Florence.  
• Pending recommendation from WCCMH provider in conjunction with Dr. Florence.  If 
recommended to proceed to make appointment with provider or go immediately to an 
Emergency Department (ED), discuss the issue with all relevant RS and participant as 
well. 
• Call 911.  
• In the case of an involuntary hospitalization/ED evaluation, call Police (RS should go 
with police since “Petition” is required). 
• In the case of a voluntary hospitalization/ED evaluation, call Ambulance to escort the 
participant. 
• In the case of acute suicidal ideation/intent, a research team member must watch the 
participant until Police/Security/Ambulance arrives.  
• 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 
RS while Police and/or Ambulance arrive. 
• The Research Coordinator needs to provide some documentation from the PI to give 
to the police/security regarding the PI’s recommendation.  
• 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.  
 

 
10 
 
 
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