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OpenTrials
Completed

NCT Number: NCT05345184

Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Mental Disorders Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Self-Injurious Behavior Suicide Prevention

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)

Behavioral

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

Services as Usual (SAU)

Behavioral

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

Primary outcomes

  1. Calgary Depression Rating Scale (CDRS)

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

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

  2. Positive and Negative Syndrome Scale (PANSS)

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

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

  3. Columbia Suicide Severity Rating Scale (C-SSRS)

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

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

Secondary outcomes

  1. Beck Hopelessness Scale

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

    A scale to measure hopelessness, higher scores indicate greater hopelessness (range of 0-20)

  2. Defeat Scale (D Scale)

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

    A scale to measure defeat, higher scores indicate greater defeat (range of 0-64)

  3. The Entrapment Scale

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

    A scale to measure entrapment, higher scores indicate greater entrapment (range of 0-64)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 25, 2022
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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