Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04689867
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The investigators are modifying and testing the preliminary effectiveness and implementation of a Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) intervention. In this phase of the study, CBSPp will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit clients receiving services at a community mental health setting who have a schizophrenia spectrum disorder and recent suicidal thoughts and behaviors to receive the behavioral intervention for 10-weeks. Providers will be recruited and trained to deliver the intervention. Both clients and providers will be assessed at baseline, 5 weeks after treatment begins, upon completion of treatment (10 weeks after treatment begins, and 3 month follow up after completion of treatment.

Condition or Disease	Intervention/Treatment	Phase
Suicide; Psychosis	Behavioral: Cognitive Behavioral Suicide Prevention for psychosis CBSPp)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive-behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 1 Open Pilot Trial
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Apr 1, 2022
• Actual Study Completion Date: Apr 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CBSPp Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.	Behavioral: Cognitive Behavioral Suicide Prevention for psychosis CBSPp); Cognitive and behavioral approach to suicide prevention among individuals with psychosis

Outcome Measures

Primary Outcome Measures

1. Suicidal Behaviors Questionnaire-Revised (SBQ-R) [3 month follow-up]

   A scale to measure suicide thoughts and behavior with scores ranging from 3 to 18 and higher scores indicating greater suicide thoughts and behaviors.

Secondary Outcome Measures

1. Calgary Depression Rating Scale (CDRS) [3 month follow-up]

   A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lindsay Bornheimer, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT04689867
• Other Study ID Numbers: HUM00152247; R34MH123609
• First Posted: Dec 30, 2020
• Last Update Posted: Apr 13, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lindsay Bornheimer, Assistant Professor, University of Michigan: cognitive behavioral therapy; suicide prevention; community mental health
• Additional relevant MeSH terms: Psychotic Disorders; Mental Disorders; Suicide

Study Results

No Results Posted as of Apr 13, 2022