Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

NCT05345184 | Completed Results DMC

• 2 other identifiers: HUM00211008R34MH123609
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Psychosis

Keywords

suicide prevention; cognitive behavioral therapy; community mental health

Outcome Measures

Primary Outcomes (3)

• Calgary Depression Rating Scale (CDRS)

  A scale to measure depression, higher scores indicate greater depression (range of 0-27)

  4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

• Positive and Negative Syndrome Scale (PANSS)

  A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210)

  4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

• Columbia Suicide Severity Rating Scale (C-SSRS)

  A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5)

  4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

Secondary Outcomes (3)

• Beck Hopelessness Scale

  4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

• Defeat Scale (D Scale)

  4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

• The Entrapment Scale

  4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months).

Study Arms (2)

Cognitive Behavioral Suicide Prevention for psychosis (treatment group)

EXPERIMENTAL

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)

Services as Usual (SAU; comparison group)

ACTIVE COMPARATOR

Services as usual involve standard and current services that clients are eligible for receiving.

Behavioral: Services as Usual (SAU)

Interventions

Services as Usual (SAU) BEHAVIORAL

Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)

Services as Usual (SAU; comparison group)

Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) BEHAVIORAL

Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis

Cognitive Behavioral Suicide Prevention for psychosis (treatment group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Schizophrenia Spectrum Disorder
• Suicide ideation and/or attempt within 3 months of screening
• Ability to speak and read in English
• to 65 years of age

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Suicide; Psychotic Disorders; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Lindsay Bornheimer
• Organization: University of Michigan

bornheim@umich.edu

1 (734) 764-3309

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 25, 2022
• Study Start: September 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)