Suicide
Conditions
Keywords
depression, prevention, Veterans health
Brief summary
The proposed study seeks to test the efficacy of an intervention to reduce suicide behaviors in Veterans. The Veterans Coping Long Term with Active Suicide Program (CLASP-VA) is an innovative, telephone-based intervention that combines elements of individual therapy, case management, and significant other/family therapy and is designed to be integrated into a VA system.
Detailed description
Suicide is a leading cause of death for military personnel, and for the first time in recorded history, rates of military suicides are exceeding civilian rates. Despite public and patient health costs associated with suicidal ideation and behavior, existing efforts haven't appreciably reduced rates of suicidal behavior in the military. Consequently, finding novel, efficacious, and acceptable methods to reduce suicide behaviors is imperative. The Veteran's Coping Long Term with Active Suicide Program (CLASP-VA) is a unique suicide reduction intervention that directly targets high-risk patients at the time of hospital discharge. It is one of the few empirically-developed and promising interventions (e.g., strong pilot data) for individuals hospitalized for suicide behavior. The primary objective of this study is to test the efficacy of the CLASP intervention compared to a treatment as usual plus Safety Assessment and Follow-up Evaluation (SAFE) control condition. Efficacy will be determined by primary outcomes including: number of attempts, number of re-hospitalizations, severity, and chronicity of suicidal ideation. A secondary objective is identifying the types of patients who receive the most benefit from the CLASP-VA intervention.
Interventions
BEHAVIORALCoping Long Term with Active Suicide (CLASP)
6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management
OTHERSafety Assessment and Follow Up Evaluation
enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider
Sponsors
Butler Hospital
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* suicide attempt or suicidal ideation with any methods, plan, and/or intent to make a suicide attempt within 1 week of hospitalization * age greater than 18 * have a telephone * ability to speak, read, and understand spoken English sufficiently well to complete the procedures of the study
Exclusion criteria
* long-term psychiatric disorder * diagnosis of borderline personality disorder * cognitive impairment which would interfere with adequate participation in the project (MMSE \<20)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | baseline, 3, 6, 9, & 12 month post-hospitalization | Items measuring attempt behavior (number of Actual Attempts, number of Aborted Attempts, number of Interrupted Attempts) From the Columbia Suicide Severity Rating Scale were summed to create a composite variable indexing attempt behavior. Higher scores indicate more attempt behavior. We log transformed this variable at all time points to meet assumptions of normality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Beck Hopelessness Scale | Baseline, 3, 6, 9, & 12 month follow up | The Beck Hopelessness Scale was used to measure changes in hopelessness from baseline to 12-month followup. Items are dichotomous (0: False and 1: True), with a total score ranging from 0-20. Higher scores indicate greater hopelessness. |
| Brief Symptom Inventory | Baseline, 3, 6, 9, & 12 month follow up | The Brief Symptom Inventory is a validated, self-reported instrument assessing current psychiatric symptomatology. Possible scores for each item range from 0 (not at all) to 4 (extremely), and total scores are represented by a Global Severity Index (range 0 to 212).Higher scores indicate greater psychological distress. |
| World Health Organization Disability Assessment Schedule (WHODAS) II | Baseline, 3, 6, 9, & 12 month follow ups | The World Health Organization Disability Assessment Schedule (WHODAS II) is a validated, self-reported instrument assessing current impairment in functioning. Possible scores for each item range from 1 (None) to 5 (Extreme or cannot do). We calculated an Average Global Score for inclusion in analyses by dividing the total score by the number of items included in the measure (possible range of 1-5). Higher scores indicate greater impairment in functioning. We examined changes in overall functioning from baseline in these analyses. |
| Treatment History Interview | 3, 6, 9, & 12 month follow up | We used an item measuring psychiatric hospitalizations from the Treatment History Interview to measure treatment utilization. Study participants indicated how many times they had been psychiatrically hospitalized since the prior study timepoint. We log transformed this variable at each timepoint to meet statistical assumptions of normality for our analyses. |
| Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | baseline, 3, 6, 9, & 12 month post-hospitalization | Intensity of ideation was measured using the Columbia Scale for Suicide Ideation intensity of ideation item. Item responses range from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), with higher scores indicating more severe ideation. Minimum score on the ideation measure is 1 and maximum score is 5. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Providence VA Medical center psychiatric inpatient unit
Pre-assignment details
One hundred and seven participants completed baseline assessments and were found to be eligible for the study. Two participants were lost prior to randomization since they could not be contacted by research staff.
Participants by arm
| Arm | Count |
|---|---|
| CLASP Intervention + Enhanced Monitoring A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other.
Plus
Enhanced monitoring consisting of assessment and medical record notes sent to mental health providers. | 52 |
| Safety Assessment and Follow up Evaluation + TAU Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers. | 53 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 3 |
| Overall Study | Withdrawal by Subject | 9 | 4 |
| Overall Study | Withdrawn by investigator | 2 | 2 |
Baseline characteristics
| Characteristic | CLASP Intervention + Enhanced Monitoring | Safety Assessment and Follow up Evaluation + TAU | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 47 Participants | 95 Participants |
| Age, Continuous | 46.56 years | 48.85 years | 47.74 years STANDARD_DEVIATION 14.4 |
| Beck Hopelessness Scale | 12.98 units on a scale STANDARD_DEVIATION 5.69 | 12.96 units on a scale STANDARD_DEVIATION 5.53 | 12.97 units on a scale STANDARD_DEVIATION 5.58 |
| Brief Symptom Inventory | 2.02 units on a scale STANDARD_DEVIATION 0.67 | 1.99 units on a scale STANDARD_DEVIATION 0.68 | 2.00 units on a scale STANDARD_DEVIATION 0.68 |
| Columbia Suicide Severity Rating Scale - Attempt Behavior | 1.40 Suicide attempts STANDARD_DEVIATION 1.76 | 1.55 Suicide attempts STANDARD_DEVIATION 2.06 | 1.48 Suicide attempts STANDARD_DEVIATION 1.92 |
| Columbia Suicide Severity Rating Scale -Ideation | 4.28 units on a scale STANDARD_DEVIATION 0.73 | 4.26 units on a scale STANDARD_DEVIATION 0.836 | 4.27 units on a scale STANDARD_DEVIATION 0.782 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 46 Participants | 42 Participants | 88 Participants |
| Region of Enrollment United States | 52 Participants | 53 Participants | 105 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 46 Participants | 49 Participants | 95 Participants |
| WHODAS | 93.02 units on a scale STANDARD_DEVIATION 21.84 | 92.78 units on a scale STANDARD_DEVIATION 23.67 | 92.90 units on a scale STANDARD_DEVIATION 22.69 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 52 | 0 / 53 |
| other Total, other adverse events | 0 / 52 | 0 / 53 |
| serious Total, serious adverse events | 21 / 52 | 17 / 53 |
Outcome results
Primary
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior
Items measuring attempt behavior (number of Actual Attempts, number of Aborted Attempts, number of Interrupted Attempts) From the Columbia Suicide Severity Rating Scale were summed to create a composite variable indexing attempt behavior. Higher scores indicate more attempt behavior. We log transformed this variable at all time points to meet assumptions of normality.
Time frame: baseline, 3, 6, 9, & 12 month post-hospitalization
Population: The sample sizes used in this analysis are smaller than the full samples recruited per group because of dropout from baseline to 1 year followup.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | 3 Month Followup | 0.14 log(attempts) | Standard Deviation 0.3 |
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | 9 Month Followup | 0.09 log(attempts) | Standard Deviation 0.22 |
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | 6 Month Followup | 0.06 log(attempts) | Standard Deviation 0.15 |
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | 12 Month Followup | 0.06 log(attempts) | Standard Deviation 0.17 |
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | Baseline | 0.13 log(attempts) | Standard Deviation 0.16 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | 12 Month Followup | 0.03 log(attempts) | Standard Deviation 0.11 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | Baseline | 0.18 log(attempts) | Standard Deviation 0.21 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | 3 Month Followup | 0.05 log(attempts) | Standard Deviation 0.16 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | 6 Month Followup | 0.01 log(attempts) | Standard Deviation 0.08 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior | 9 Month Followup | 0.03 log(attempts) | Standard Deviation 0.11 |
p-value: 0.13RMANOVA
Secondary
Brief Symptom Inventory
The Brief Symptom Inventory is a validated, self-reported instrument assessing current psychiatric symptomatology. Possible scores for each item range from 0 (not at all) to 4 (extremely), and total scores are represented by a Global Severity Index (range 0 to 212).Higher scores indicate greater psychological distress.
Time frame: Baseline, 3, 6, 9, & 12 month follow up
Population: There are fewer subjects in this analysis than were recruited for both groups at baseline due to dropout across timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLASP Intervention | Brief Symptom Inventory | 3 Month Followup | 1.30 score on a scale | Standard Deviation 0.9 |
| CLASP Intervention | Brief Symptom Inventory | 9 Month Followup | 0.93 score on a scale | Standard Deviation 0.75 |
| CLASP Intervention | Brief Symptom Inventory | 6 Month Followup | 1.26 score on a scale | Standard Deviation 0.84 |
| CLASP Intervention | Brief Symptom Inventory | 12 Month Followup | 1.08 score on a scale | Standard Deviation 0.9 |
| CLASP Intervention | Brief Symptom Inventory | Baseline | 1.93 score on a scale | Standard Deviation 0.68 |
| Safety Assessment and Follow up Evaluation | Brief Symptom Inventory | 12 Month Followup | 1.06 score on a scale | Standard Deviation 0.97 |
| Safety Assessment and Follow up Evaluation | Brief Symptom Inventory | Baseline | 1.98 score on a scale | Standard Deviation 0.65 |
| Safety Assessment and Follow up Evaluation | Brief Symptom Inventory | 3 Month Followup | 1.17 score on a scale | Standard Deviation 0.84 |
| Safety Assessment and Follow up Evaluation | Brief Symptom Inventory | 6 Month Followup | 1.23 score on a scale | Standard Deviation 0.86 |
| Safety Assessment and Follow up Evaluation | Brief Symptom Inventory | 9 Month Followup | 1.10 score on a scale | Standard Deviation 0.86 |
p-value: 0.49RMANOVA
Secondary
Changes in Beck Hopelessness Scale
The Beck Hopelessness Scale was used to measure changes in hopelessness from baseline to 12-month followup. Items are dichotomous (0: False and 1: True), with a total score ranging from 0-20. Higher scores indicate greater hopelessness.
Time frame: Baseline, 3, 6, 9, & 12 month follow up
Population: 2 participants from the CLASP condition were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment. Number of participants analyzed is smaller per group due to dropout from baseline to 12 month follow-up and missing data for some time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLASP Intervention | Changes in Beck Hopelessness Scale | 3 Month Followup | 9.12 score on a scale | Standard Deviation 6.59 |
| CLASP Intervention | Changes in Beck Hopelessness Scale | 9 Month Followup | 8.65 score on a scale | Standard Deviation 7.13 |
| CLASP Intervention | Changes in Beck Hopelessness Scale | 6 Month Followup | 10.06 score on a scale | Standard Deviation 7.5 |
| CLASP Intervention | Changes in Beck Hopelessness Scale | 12 Month Followup | 9.00 score on a scale | Standard Deviation 6.78 |
| CLASP Intervention | Changes in Beck Hopelessness Scale | Baseline | 13.65 score on a scale | Standard Deviation 5.62 |
| Safety Assessment and Follow up Evaluation | Changes in Beck Hopelessness Scale | 12 Month Followup | 7.58 score on a scale | Standard Deviation 6.72 |
| Safety Assessment and Follow up Evaluation | Changes in Beck Hopelessness Scale | Baseline | 13.21 score on a scale | Standard Deviation 5.16 |
| Safety Assessment and Follow up Evaluation | Changes in Beck Hopelessness Scale | 3 Month Followup | 9.28 score on a scale | Standard Deviation 7.32 |
| Safety Assessment and Follow up Evaluation | Changes in Beck Hopelessness Scale | 6 Month Followup | 9.28 score on a scale | Standard Deviation 6.41 |
| Safety Assessment and Follow up Evaluation | Changes in Beck Hopelessness Scale | 9 Month Followup | 7.31 score on a scale | Standard Deviation 6.5 |
p-value: 0.79RMANOVA
Secondary
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity
Intensity of ideation was measured using the Columbia Scale for Suicide Ideation intensity of ideation item. Item responses range from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), with higher scores indicating more severe ideation. Minimum score on the ideation measure is 1 and maximum score is 5.
Time frame: baseline, 3, 6, 9, & 12 month post-hospitalization
Population: The sample sizes used in this analysis are smaller than the full samples recruited per group because of dropout from baseline to 1 year followup.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | 9 Month Followup | 1.64 units on a scale | Standard Deviation 1.91 |
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | Baseline | 3.88 units on a scale | Standard Deviation 0.73 |
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | 12 Month Followup | 1.84 units on a scale | Standard Deviation 1.89 |
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | 3 Month Followup | 2.56 units on a scale | Standard Deviation 1.78 |
| CLASP Intervention | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | 6 Month Followup | 2.08 units on a scale | Standard Deviation 1.91 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | 3 Month Followup | 2.47 units on a scale | Standard Deviation 1.81 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | 6 Month Followup | 1.66 units on a scale | Standard Deviation 1.77 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | 9 Month Followup | 1.38 units on a scale | Standard Deviation 1.74 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | 12 Month Followup | 1.25 units on a scale | Standard Deviation 1.61 |
| Safety Assessment and Follow up Evaluation | Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity | Baseline | 4.16 units on a scale | Standard Deviation 0.92 |
Secondary
Treatment History Interview
We used an item measuring psychiatric hospitalizations from the Treatment History Interview to measure treatment utilization. Study participants indicated how many times they had been psychiatrically hospitalized since the prior study timepoint. We log transformed this variable at each timepoint to meet statistical assumptions of normality for our analyses.
Time frame: 3, 6, 9, & 12 month follow up
Population: The number of participants in this analysis per group is smaller than was recruited at baseline due to dropout across time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLASP Intervention | Treatment History Interview | 3 Month Followup | 0.12 log(psychiatric hospitalizations) | Standard Deviation 0.2 |
| CLASP Intervention | Treatment History Interview | 6 Month Followup | 0.03 log(psychiatric hospitalizations) | Standard Deviation 0.09 |
| CLASP Intervention | Treatment History Interview | 9 Month Followup | 0.04 log(psychiatric hospitalizations) | Standard Deviation 0.1 |
| CLASP Intervention | Treatment History Interview | 12 Month Followup | 0.05 log(psychiatric hospitalizations) | Standard Deviation 0.13 |
| Safety Assessment and Follow up Evaluation | Treatment History Interview | 12 Month Followup | 0.07 log(psychiatric hospitalizations) | Standard Deviation 0.14 |
| Safety Assessment and Follow up Evaluation | Treatment History Interview | 3 Month Followup | 0.07 log(psychiatric hospitalizations) | Standard Deviation 0.16 |
| Safety Assessment and Follow up Evaluation | Treatment History Interview | 9 Month Followup | 0.06 log(psychiatric hospitalizations) | Standard Deviation 0.12 |
| Safety Assessment and Follow up Evaluation | Treatment History Interview | 6 Month Followup | 0.06 log(psychiatric hospitalizations) | Standard Deviation 0.14 |
p-value: 0.62RMANOVA
Secondary
World Health Organization Disability Assessment Schedule (WHODAS) II
The World Health Organization Disability Assessment Schedule (WHODAS II) is a validated, self-reported instrument assessing current impairment in functioning. Possible scores for each item range from 1 (None) to 5 (Extreme or cannot do). We calculated an Average Global Score for inclusion in analyses by dividing the total score by the number of items included in the measure (possible range of 1-5). Higher scores indicate greater impairment in functioning. We examined changes in overall functioning from baseline in these analyses.
Time frame: Baseline, 3, 6, 9, & 12 month follow ups
Population: The number of participants in this analysis per group is smaller than was recruited at baseline due to dropout across time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLASP Intervention | World Health Organization Disability Assessment Schedule (WHODAS) II | 3 Month Followup | 2.12 score on a scale | Standard Deviation 0.78 |
| CLASP Intervention | World Health Organization Disability Assessment Schedule (WHODAS) II | 9 Month Followup | 2.00 score on a scale | Standard Deviation 0.61 |
| CLASP Intervention | World Health Organization Disability Assessment Schedule (WHODAS) II | 6 Month Followup | 2.17 score on a scale | Standard Deviation 0.72 |
| CLASP Intervention | World Health Organization Disability Assessment Schedule (WHODAS) II | 1 Year Followup | 2.08 score on a scale | Standard Deviation 0.82 |
| CLASP Intervention | World Health Organization Disability Assessment Schedule (WHODAS) II | Baseline | 2.58 score on a scale | Standard Deviation 0.55 |
| Safety Assessment and Follow up Evaluation | World Health Organization Disability Assessment Schedule (WHODAS) II | 1 Year Followup | 2.04 score on a scale | Standard Deviation 0.85 |
| Safety Assessment and Follow up Evaluation | World Health Organization Disability Assessment Schedule (WHODAS) II | Baseline | 2.54 score on a scale | Standard Deviation 0.69 |
| Safety Assessment and Follow up Evaluation | World Health Organization Disability Assessment Schedule (WHODAS) II | 3 Month Followup | 2.09 score on a scale | Standard Deviation 0.79 |
| Safety Assessment and Follow up Evaluation | World Health Organization Disability Assessment Schedule (WHODAS) II | 6 Month Followup | 2.07 score on a scale | Standard Deviation 0.71 |
| Safety Assessment and Follow up Evaluation | World Health Organization Disability Assessment Schedule (WHODAS) II | 9 Month Followup | 1.93 score on a scale | Standard Deviation 0.76 |
p-value: 0.96RMANOVA