Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

Suicide Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345184
• Other study ID #: HUM00211008
• Secondary ID: R34MH123609
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Lindsay A Bornheimer, PhD
• Phone: (734) 615-2915
• Email: bornheim[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Suicide
• Suicide Prevention

Intervention

Behavioral:
• Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)
Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
• Services as Usual (SAU)
Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calgary Depression Rating Scale (CDRS) change from baseline	A scale to measure depression, higher scores indicate greater depression	3-months after baseline
Primary	Positive and Negative Syndrome Scale (PANSS) change from baseline	A scale to measure psychosis symptoms, higher scores indicate greater psychosis	3-months after baseline
Primary	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	Beck Hopelessness Scale change from baseline	A scale to measure hopelessness, higher scores indicate greater hopelessness	3-months after baseline
Secondary	Defeat Scale (D Scale) change from baseline	A scale to measure defeat, higher scores indicate greater defeat	3-months after baseline
Secondary	The Entrapment Scale change from baseline	A scale to measure entrapment, higher scores indicate greater entrapment	3-months after baseline
Secondary	Suicide Stroop Task change from baseline	A cognitive Stroop tasks to assess information processing, information processing is evaluated in time	3-months after baseline
Secondary	Resilience Appraisals Scale (RAS) change from baseline	A scale to measure appraisals, higher scores indicate stronger resilience appraisals	3-months after baseline
Secondary	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