Clinical trial NCT05345184: 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
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Psychosis
Keywords: suicide prevention
cognitive behavioral therapy
community mental health
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-04-25
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Calgary Depression Rating Scale (CDRS) change from baseline
timeFrame: 3-months after baseline
measure: Positive and Negative Syndrome Scale (PANSS) change from baseline
timeFrame: 3-months after baseline
measure: Columbia Suicide Severity Rating Scale (C-SSRS) change from baseline
timeFrame: 3-months after baseline
Secondary outcomes:
measure: Beck Hopelessness Scale change from baseline
timeFrame: 3-months after baseline
measure: Defeat Scale (D Scale) change from baseline
timeFrame: 3-months after baseline
measure: The Entrapment Scale change from baseline
timeFrame: 3-months after baseline
measure: Suicide Stroop Task change from baseline
timeFrame: 3-months after baseline
measure: Resilience Appraisals Scale (RAS) change from baseline
timeFrame: 3-months after baseline
measure: Suicide Concept Sort Task (SCS) change from baseline
timeFrame: 3-months after baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: