Psychosis, Suicide
Conditions
Keywords
cognitive behavioral therapy, suicide prevention, community mental health
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.
Interventions
BEHAVIORALCognitive Behavioral Suicide Prevention for psychosis CBSPp)
Cognitive and behavioral approach to suicide prevention among individuals with psychosis
Sponsors
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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) | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) | 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. |
| Positive and Negative Symptom Rating Scale (PANSS) | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) | 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. |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Hopelessness Scale | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) | 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. |
| The Entrapment Scale | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) | 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. |
| The Defeat Scale | baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment) | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of eight clients consented to participate in the Aim 1 open pilot study and were subsequently scheduled to attend a screening assessment. One individual was not eligible per the screening assessment, and two individuals did not attend the scheduled screening assessment. As a result, five individuals were eligible to participate and began treatment.
Participants by arm
| Arm | Count |
|---|---|
| CBSPp Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.
Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | CBSPp |
|---|---|
| Age, Continuous | 44.66 years STANDARD_DEVIATION 13.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Lifetime History of Suicide Attempt No | 1 Participants |
| Lifetime History of Suicide Attempt Yes | 4 Participants |
| Past Week Suicide Attempt No | 5 Participants |
| Past Week Suicide Attempt Yes | 0 Participants |
| Past Week Suicide Ideation No | 2 Participants |
| Past Week Suicide Ideation Yes | 3 Participants |
| Past Week Suicide Plan No | 2 Participants |
| Past Week Suicide Plan Yes | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 3 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBSPp | Calgary Depression Rating Scale (CDRS) | Baseline | 13.60 score on a scale | Standard Deviation 5.73 |
| CBSPp | Calgary Depression Rating Scale (CDRS) | mid-treatment | 9.00 score on a scale | Standard Deviation 2.92 |
| CBSPp | Calgary Depression Rating Scale (CDRS) | post-treatment | 11.00 score on a scale | Standard Deviation 2.58 |
| CBSPp | Calgary Depression Rating Scale (CDRS) | follow-up | 7.60 score on a scale | Standard Deviation 3.65 |
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)
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
Population: One individual at post-treatment did not complete the assessment with research staff
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline suicide ideation | Yes | 3 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline suicide ideation | No | 2 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline suicide plan | Yes | 3 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline suicide plan | No | 2 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline suicide attempt | Yes | 0 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline suicide attempt | No | 5 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Mid-treatment suicide ideation | Yes | 3 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Mid-treatment suicide ideation | No | 2 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Mid-treatment suicide plan | Yes | 4 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Mid-treatment suicide plan | No | 1 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Mid-treatment suicide attempt | Yes | 0 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Mid-treatment suicide attempt | No | 5 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Post-treatment suicide ideation | Yes | 2 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Post-treatment suicide ideation | No | 2 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Post-treatment suicide plan | Yes | 1 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Post-treatment suicide plan | No | 3 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Post-treatment suicide attempt | Yes | 0 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Post-treatment suicide attempt | No | 4 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Follow-up suicide ideation | Yes | 3 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Follow-up suicide ideation | No | 2 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Follow-up suicide plan | Yes | 2 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Follow-up suicide plan | No | 3 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Follow-up suicide attempt | Yes | 0 Participants |
| CBSPp | Columbia-Suicide Severity Rating Scale (C-SSRS) | Follow-up suicide attempt | No | 5 Participants |
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.
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Baseline positive sub scale | 20.20 score on a scale | Standard Deviation 3.27 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Baseline negative sub scale | 18.20 score on a scale | Standard Deviation 5.89 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Baseline general sub scale | 42.40 score on a scale | Standard Deviation 7.96 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Mid-treatment positive sub scale | 20.40 score on a scale | Standard Deviation 4.16 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Mid-treatment negative sub scale | 19.00 score on a scale | Standard Deviation 7.81 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Mid-treatment general sub scale | 41.20 score on a scale | Standard Deviation 8.53 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Post-treatment positive sub scale | 20.00 score on a scale | Standard Deviation 7.62 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Post-treatment negative sub scale | 17.75 score on a scale | Standard Deviation 6.4 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Post-treatment general sub scale | 37.50 score on a scale | Standard Deviation 10.38 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Follow-up positive sub scale | 20.80 score on a scale | Standard Deviation 7.66 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Follow-up negative sub scale | 18.00 score on a scale | Standard Deviation 8.25 |
| CBSPp | Positive and Negative Symptom Rating Scale (PANSS) | Follow-up general sub scale | 43.4 score on a scale | Standard Deviation 12.42 |
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.
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBSPp | Beck Hopelessness Scale | Baseline | 12.80 score on a scale | Standard Deviation 8.17 |
| CBSPp | Beck Hopelessness Scale | Mid-treatment | 10.40 score on a scale | Standard Deviation 8.76 |
| CBSPp | Beck Hopelessness Scale | Post-treatment | 12.00 score on a scale | Standard Deviation 7.44 |
| CBSPp | Beck Hopelessness Scale | Follow-up | 9.80 score on a scale | Standard Deviation 8.87 |
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.
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBSPp | The Defeat Scale | Baseline | 43.00 score on a scale | Standard Deviation 18.41 |
| CBSPp | The Defeat Scale | Mid-treatment | 40.40 score on a scale | Standard Deviation 20.62 |
| CBSPp | The Defeat Scale | Post-treatment | 39.00 score on a scale | Standard Deviation 15.43 |
| CBSPp | The Defeat Scale | Follow-up | 41.5 score on a scale | Standard Deviation 14.27 |
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.
Time frame: baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBSPp | The Entrapment Scale | Baseline | 35.80 score on a scale | Standard Deviation 15.61 |
| CBSPp | The Entrapment Scale | Mid-treatment | 30.40 score on a scale | Standard Deviation 21.1 |
| CBSPp | The Entrapment Scale | Post-treatment | 28.75 score on a scale | Standard Deviation 18.39 |
| CBSPp | The Entrapment Scale | Follow-up | 36.0 score on a scale | Standard Deviation 21.09 |