Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1

NCT04689867 | Completed Results DMC

• 2 other identifiers: HUM00152247R34MH123609
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 to test our approach to measurement prior to the Aim 2 RCT (registered separately). Clients will be assessed at three additional timepoints (middle of treatment, end of treatment, and 2 months after treatment ends.

Conditions

Suicide; Psychosis

Keywords

cognitive behavioral therapy; suicide prevention; community mental health

Outcome Measures

Primary Outcomes (3)

• Calgary Depression Rating Scale (CDRS)

  A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors.

  baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

• Positive and Negative Symptom Rating Scale (PANSS)

  A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms.

  baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  A scale to measure suicide thoughts and behavior. The following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death. A numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent)

  baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

Secondary Outcomes (3)

• Beck Hopelessness Scale

  baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

• The Entrapment Scale

  baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

• The Defeat Scale

  baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

Study Arms (1)

CBSPp

EXPERIMENTAL

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)

Interventions

Cognitive Behavioral Suicide Prevention for psychosis CBSPp) BEHAVIORAL

Cognitive and behavioral approach to suicide prevention among individuals with psychosis

CBSPp

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

Limitations and Caveats

This was an open pilot trial, therefore no randomization occurred nor comparison between receiving treatment or not. All participants received treatment. The next phase of our study (Aim 2; registered separately) will report on the RCT.

Results Point of Contact

• Title: Lindsay Bornheimer
• Organization: University of Michigan

bornheim@umich.edu

(734) 615-2915

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 30, 2020
• Study Start: September 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 11, 2022
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)