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Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

Primary Purpose

Suicide, Psychosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)
Services as Usual (SAU)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring suicide prevention, cognitive behavioral therapy, community mental health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Suicide Prevention for psychosis (treatment group)

Services as Usual (SAU; comparison group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Calgary Depression Rating Scale (CDRS) change from baseline
A scale to measure depression, higher scores indicate greater depression
Positive and Negative Syndrome Scale (PANSS) change from baseline
A scale to measure psychosis symptoms, higher scores indicate greater psychosis
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

Secondary Outcome Measures

Beck Hopelessness Scale change from baseline
A scale to measure hopelessness, higher scores indicate greater hopelessness
Defeat Scale (D Scale) change from baseline
A scale to measure defeat, higher scores indicate greater defeat
The Entrapment Scale change from baseline
A scale to measure entrapment, higher scores indicate greater entrapment
Suicide Stroop Task change from baseline
A cognitive Stroop tasks to assess information processing, information processing is evaluated in time
Resilience Appraisals Scale (RAS) change from baseline
A scale to measure appraisals, higher scores indicate stronger resilience appraisals
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

Full Information

First Posted
April 12, 2022
Last Updated
October 23, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05345184
Brief Title
Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Psychosis
Keywords
suicide prevention, cognitive behavioral therapy, community mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Suicide Prevention for psychosis (treatment group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Services as Usual (SAU; comparison group)
Arm Type
Active Comparator
Arm Description
Services as usual involve standard and current services that clients are eligible for receiving.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)
Intervention Description
Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
Intervention Type
Behavioral
Intervention Name(s)
Services as Usual (SAU)
Intervention Description
Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
Primary Outcome Measure Information:
Title
Calgary Depression Rating Scale (CDRS) change from baseline
Description
A scale to measure depression, higher scores indicate greater depression
Time Frame
3-months after baseline
Title
Positive and Negative Syndrome Scale (PANSS) change from baseline
Description
A scale to measure psychosis symptoms, higher scores indicate greater psychosis
Time Frame
3-months after baseline
Title
Columbia Suicide Severity Rating Scale (C-SSRS) change from baseline
Description
A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior
Time Frame
3-months after baseline
Secondary Outcome Measure Information:
Title
Beck Hopelessness Scale change from baseline
Description
A scale to measure hopelessness, higher scores indicate greater hopelessness
Time Frame
3-months after baseline
Title
Defeat Scale (D Scale) change from baseline
Description
A scale to measure defeat, higher scores indicate greater defeat
Time Frame
3-months after baseline
Title
The Entrapment Scale change from baseline
Description
A scale to measure entrapment, higher scores indicate greater entrapment
Time Frame
3-months after baseline
Title
Suicide Stroop Task change from baseline
Description
A cognitive Stroop tasks to assess information processing, information processing is evaluated in time
Time Frame
3-months after baseline
Title
Resilience Appraisals Scale (RAS) change from baseline
Description
A scale to measure appraisals, higher scores indicate stronger resilience appraisals
Time Frame
3-months after baseline
Title
Suicide Concept Sort Task (SCS) change from baseline
Description
A cognitive card sorting task to assess schemas, cards are sorted as being closely related to not closely related to suicide as a concept
Time Frame
3-months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay A Bornheimer, PhD
Phone
(734) 615-2915
Email
bornheim@umich.edu
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay A Bornheimer, PhD
Phone
734-615-2915
Email
bornheim@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upload to NIMH Data Archive

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Cognitive Behavioral Suicide Prevention for Psychosis: Aim 2

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