Psychosis, Suicide
Conditions
Keywords
suicide prevention, cognitive behavioral therapy, community mental health
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.
Interventions
BEHAVIORALCognitive Behavioral Suicide Prevention for psychosis (CBSPp)
Cognitive and behavioral approach to suicide prevention tailored for individuals with psychosis
BEHAVIORALServices as Usual (SAU)
Standard psychiatric and behavioral services provided at community mental health (e.g., case management, medication management)
Sponsors
University of Michigan
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calgary Depression Rating Scale (CDRS) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). | A scale to measure depression, higher scores indicate greater depression (range of 0-27) |
| Positive and Negative Syndrome Scale (PANSS) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). | A scale to measure psychosis symptoms, higher scores indicate greater psychosis (range of 30-210) |
| Columbia Suicide Severity Rating Scale (C-SSRS) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). | A scale to measure suicide thoughts and behavior, higher scores indicate greater suicide thoughts and behavior (range of 0-5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Hopelessness Scale | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). | A scale to measure hopelessness, higher scores indicate greater hopelessness (range of 0-20) |
| Defeat Scale (D Scale) | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). | A scale to measure defeat, higher scores indicate greater defeat (range of 0-64) |
| The Entrapment Scale | 4 time points (baseline, mid-treatment (1 month), post-treatment (3 months), and follow-up (5 months). | A scale to measure entrapment, higher scores indicate greater entrapment (range of 0-64) |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.99 years STANDARD_DEVIATION 12.35 |
| Columbia Suicide Severity Rating Scale | 2.52 units on a scale STANDARD_DEVIATION 1.23 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 26 |
| other Total, other adverse events | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 2 / 25 | 5 / 26 |
Outcome results
None listed