search
Back to results

Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1

Primary Purpose

Suicide, Psychosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Suicide Prevention for psychosis CBSPp)
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 cognitive behavioral therapy, suicide prevention, 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 Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBSPp

Arm Description

Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.

Outcomes

Primary Outcome Measures

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.
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.
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)

Secondary Outcome Measures

Beck Hopelessness Scale
A scale to measure hopelessness using 20 items with binary (true/false) response categories. Scores are summed and range from 0-20, higher scores indicate greater hopelessness is present.
The Entrapment Scale
A scale to measure entrapment using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, and higher scores indicate greater feelings of being entrapped.
The Defeat Scale
A scale to measure defeat using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, higher scores indicate greater feelings of being defeated.

Full Information

First Posted
December 22, 2020
Last Updated
April 2, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04689867
Brief Title
Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1
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 to Test Modified Treatment and Measurement Prior to Aim 2 RCT (Registered Separately)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBSPp
Arm Type
Experimental
Arm Description
Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Suicide Prevention for psychosis CBSPp)
Intervention Description
Cognitive and behavioral approach to suicide prevention among individuals with psychosis
Primary Outcome Measure Information:
Title
Calgary Depression Rating Scale (CDRS)
Description
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.
Time Frame
baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Title
Positive and Negative Symptom Rating Scale (PANSS)
Description
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.
Time Frame
baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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)
Time Frame
baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Secondary Outcome Measure Information:
Title
Beck Hopelessness Scale
Description
A scale to measure hopelessness using 20 items with binary (true/false) response categories. Scores are summed and range from 0-20, higher scores indicate greater hopelessness is present.
Time Frame
baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Title
The Entrapment Scale
Description
A scale to measure entrapment using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, and higher scores indicate greater feelings of being entrapped.
Time Frame
baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Title
The Defeat Scale
Description
A scale to measure defeat using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, higher scores indicate greater feelings of being defeated.
Time Frame
baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)

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)
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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

Learn more about this trial

Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1

We'll reach out to this number within 24 hrs