Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

Study Overview
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Brief Summary
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Investigators will evaluate the feasibility and preliminary effectiveness of modified Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) in comparison to services-as-usual (SAU) in a randomized controlled trial. Investigators will recruit adult clients receiving services at a community mental health (CMH) setting who have a schizophrenia spectrum disorder and recent suicidal thoughts or behaviors within 3 months of screening (n=60). Client participants will be screened, enrolled and randomized to the CBSPp or SAU group. A 4-wave design will include quantitative assessments at baseline (T1), 1-month after baseline (T2), 3-months after baseline (T3), and 5-months after baseline (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 from T1-T3 to evaluate the implementation process, including in-depth qualitative interviews at T3.

Official Title
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Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive Behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 2 RCT

Conditions
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Suicide, Psychosis

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)
* Behavioral: Services as Usual (SAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia Spectrum Disorder Suicide ideation and/or attempt within 3 months of screening Ability to speak and read in English 18 to 65 years of age Exclusion Criteria: 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) Inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH Impaired capacity (cognitive capacity)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Suicide Prevention for psychosis (treatment group)<br>Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions in addition to standard/current services. | Behavioral: Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)<br>* Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis<br>|
| Active Comparator: Services as Usual (SAU; comparison group)<br>Services as usual involve standard and current services that clients are eligible for receiving. | Behavioral: Services as Usual (SAU)<br>* Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calgary Depression Rating Scale (CDRS) change from baseline | A scale to measure depression, higher scores indicate greater depression | 3-months after baseline | 
| Positive and Negative Syndrome Scale (PANSS) change from baseline | A scale to measure psychosis symptoms, higher scores indicate greater psychosis | 3-months after baseline | 
| Columbia Suicide Severity Rating Scale (C-SSRS) change from baseline | A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior | 3-months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Hopelessness Scale change from baseline | A scale to measure hopelessness, higher scores indicate greater hopelessness | 3-months after baseline | 
| Defeat Scale (D Scale) change from baseline | A scale to measure defeat, higher scores indicate greater defeat | 3-months after baseline | 
| The Entrapment Scale change from baseline | A scale to measure entrapment, higher scores indicate greater entrapment | 3-months after baseline | 
| Suicide Stroop Task change from baseline | A cognitive Stroop tasks to assess information processing, information processing is evaluated in time | 3-months after baseline | 
| Resilience Appraisals Scale (RAS) change from baseline | A scale to measure appraisals, higher scores indicate stronger resilience appraisals | 3-months after baseline | 
| Suicide Concept Sort Task (SCS) change from baseline | A cognitive card sorting task to assess schemas, cards are sorted as being closely related to not closely related to suicide as a concept | 3-months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suicide prevention, cognitive behavioral therapy, community mental health