Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

Not Applicable

Completed

• Conditions: Suicide; Psychosis
• Interventions: Behavioral: Cognitive Behavioral Suicide Prevention for psychosis (CBSPp); Behavioral: Services as Usual (SAU)

• Registration Number: NCT05345184
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-25
• Study Start: 2022-09-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Suicide Prevention for psychosis (treatment group)	Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)	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.
Services as Usual (SAU; comparison group)	Services as Usual (SAU)	Services as usual involve standard and current services that clients are eligible for receiving.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Entrapment Scale change from baseline	3-months after baseline	A scale to measure entrapment, higher scores indicate greater entrapment
Suicide Concept Sort Task (SCS) change from baseline	3-months after 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
Suicide Stroop Task change from baseline	3-months after baseline	A cognitive Stroop tasks to assess information processing, information processing is evaluated in time
Defeat Scale (D Scale) change from baseline	3-months after baseline	A scale to measure defeat, higher scores indicate greater defeat
Resilience Appraisals Scale (RAS) change from baseline	3-months after baseline	A scale to measure appraisals, higher scores indicate stronger resilience appraisals
Beck Hopelessness Scale change from baseline	3-months after baseline	A scale to measure hopelessness, higher scores indicate greater hopelessness

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States