Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1

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 1 Open Pilot Trial to Test Modified Treatment and Measurement Prior to Aim 2 RCT (Registered Separately)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689867
• Other study ID #: HUM00152247
• Secondary ID: R34MH123609
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 11, 2022

Study information

• Verified date: April 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 11, 2022
• Est. primary completion date: April 1, 2022
• 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

Intervention

Behavioral:
• Cognitive Behavioral Suicide Prevention for psychosis CBSPp)
Cognitive and behavioral approach to suicide prevention among individuals with psychosis

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