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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05345184
Other study ID # HUM00211008
Secondary ID R34MH123609
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date July 2024

Study information

Verified date October 2023
Source University of Michigan
Contact Lindsay A Bornheimer, PhD
Phone (734) 615-2915
Email bornheim@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date July 2024
Est. primary completion date May 2024
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)

Study Design


Intervention

Behavioral:
Cognitive Behavioral Suicide Prevention for psychosis (CBSPp)
Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
Services as Usual (SAU)
Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)

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) change from baseline A scale to measure depression, higher scores indicate greater depression 3-months after baseline
Primary Positive and Negative Syndrome Scale (PANSS) change from baseline A scale to measure psychosis symptoms, higher scores indicate greater psychosis 3-months after baseline
Primary 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 3-months after baseline
Secondary Beck Hopelessness Scale change from baseline A scale to measure hopelessness, higher scores indicate greater hopelessness 3-months after baseline
Secondary Defeat Scale (D Scale) change from baseline A scale to measure defeat, higher scores indicate greater defeat 3-months after baseline
Secondary The Entrapment Scale change from baseline A scale to measure entrapment, higher scores indicate greater entrapment 3-months after baseline
Secondary Suicide Stroop Task change from baseline A cognitive Stroop tasks to assess information processing, information processing is evaluated in time 3-months after baseline
Secondary Resilience Appraisals Scale (RAS) change from baseline A scale to measure appraisals, higher scores indicate stronger resilience appraisals 3-months after baseline
Secondary 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 3-months after baseline
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