Clinical trial NCT04689867: 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
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Psychosis
Keywords: cognitive behavioral therapy
suicide prevention
community mental health
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-12-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)
timeFrame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
measure: Positive and Negative Symptom Rating Scale (PANSS)
timeFrame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Secondary outcomes:
measure: Beck Hopelessness Scale
timeFrame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
measure: The Entrapment Scale
timeFrame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
measure: The Defeat Scale
timeFrame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: