Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

NCT ID: NCT05345184

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitive Behavioral Suicide Prevention for psychosis (treatment group)

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)

Intervention Type: BEHAVIORAL

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

Services as Usual (SAU; comparison group)

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

Group Type: ACTIVE_COMPARATOR

Services as Usual (SAU)

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)

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

Intervention Type: BEHAVIORAL

Services as Usual (SAU)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Bornheimer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R34MH123609

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00211008

Identifier Type: -

Identifier Source: org_study_id