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| Name | Class |
|---|---|
| Butler Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLASP Intervention | Experimental | A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other. |
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| Safety Assessment and follow up Evaluation | Other | Treatment as usual plus enhanced monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coping Long Term with Active Suicide (CLASP) | Behavioral | 6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 3, 6, 9, & 12 month post-hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3, 6, 9, & 12 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Marie Primack, PhD MA | Providence VA Medical Center, Providence, RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37294816 | Derived | Primack JM, Thompson MF, Peters A, Quinn M, Kelsey M, Miller IW, Bozzay M. Suicide Characteristics of Veterans Hospitalized for Suicide Ideation or Attempt. Mil Med. 2023 Nov 3;188(11-12):e3371-e3376. doi: 10.1093/milmed/usad196. |
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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 were recruited from the Providence VA Medical center psychiatric inpatient unit
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| ID | Title | Description |
|---|---|---|
| FG000 | CLASP Intervention | The Coping Long Term with Active Suicide is a 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other. |
| FG001 | Safety Assessment and Follow up Evaluation | Treatment as usual plus enhanced monitoring condition consisting of assessment and medical record notes sent to mental health providers. Coping Long Term with Active Suicide: an intervention to reduce suicide behavior in Veterans recently hospitalized for suicide attempt or ideation with intent. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Demographics survey. Item asked for age of participant at the start of the study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | log(attempts) | baseline, 3, 6, 9, & 12 month post-hospitalization |
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Adverse event data for each participant was collected for 12 months following baseline assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CLASP Intervention | A 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for medical condition | Gastrointestinal disorders | Systematic Assessment | Pancreatitis |
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The dropout rate from baseline to the final timepoint (12 months) led to small numbers of subjects analyzed per group. Some completers had missing data for interim follow-up assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Primack | Providence VAMC | 401 273-7100 | 6295 | jennifer.primack@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2017 | Oct 30, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 12, 2017 | Oct 30, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D003863 | Depression |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Safety Assessment and Follow Up Evaluation | Other | 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 |
|
| 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. |
| Baseline, 3, 6, 9, & 12 month follow up |
| 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. | Baseline, 3, 6, 9, & 12 month follow ups |
| 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. | 3, 6, 9, & 12 month follow up |
| 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. | baseline, 3, 6, 9, & 12 month post-hospitalization |
| Lost to Follow-up |
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| 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. |
| BG002 | Total | Total of all reporting groups |
2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment.
| Count of Participants |
| Participants |
|
| Age, Continuous | 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment. | Mean | Full Range | years |
|
| Age, Continuous | 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment. | Mean | Standard Deviation | years |
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| Sex: Female, Male | 2 participants were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment. | Count of Participants | Participants |
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| Race (NIH/OMB) | 2 participants in the CLASP condition failed to complete baseline measures. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| 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. | In the CLASP condition, 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures. An additional 2 failed to complete the full BHI 2 participants in the SAFE condition did not complete the BHI | Mean | Standard Deviation | units on a scale |
|
| Columbia Suicide Severity Rating Scale -Ideation | 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. | 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures. | Mean | Standard Deviation | units on a scale |
|
| Columbia Suicide Severity Rating Scale - Attempt 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. | 2 participants completed screening and were enrolled but then were lost to contact prior to completing baseline measures. | Mean | Standard Deviation | Suicide attempts |
|
| WHODAS | 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. | 2 participants in CLASP condition were lost prior to baseline completion and 2 additional participants failed to complete the WHODAS 3 participants in the control condition failed to complete the full WHODAS | Mean | Standard Deviation | units on a scale |
|
| 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. | 2 participants in the CLASp condition were lost prior to completing baseline measures. In the SAFE condition, 1 participant had missing data on the BSI | Mean | Standard Deviation | units on a scale |
|
| OG001 | Safety Assessment and Follow up Evaluation | Treatment as usual plus enhanced monitoring. |
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3, 6, 9, & 12 month follow up |
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|
|
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| 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. | There are fewer subjects in this analysis than were recruited for both groups at baseline due to dropout across timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3, 6, 9, & 12 month follow up |
|
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|
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| 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. | The number of participants in this analysis per group is smaller than was recruited at baseline due to dropout across time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3, 6, 9, & 12 month follow ups |
|
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| 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. | The number of participants in this analysis per group is smaller than was recruited at baseline due to dropout across time points. | Posted | Mean | Standard Deviation | log(psychiatric hospitalizations) | 3, 6, 9, & 12 month follow up |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3, 6, 9, & 12 month post-hospitalization |
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| 1 |
| 52 |
| 21 |
| 52 |
| 0 |
| 52 |
| EG001 | Safety Assessment and Follow up Evaluation | Treatment as usual plus enhanced monitoring. | 0 | 53 | 17 | 53 | 0 | 53 |
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| Hospitalization for suicide ideation or behavior | Psychiatric disorders | Systematic Assessment | Psychiatric hospitalization for suicide ideation or behavior |
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| Hospitalization for substance use disorders | Psychiatric disorders | Systematic Assessment | Hospitalization for substance use disorder or detox |
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| Hospitalization for chest pain | Cardiac disorders | Systematic Assessment |
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| Hospitalization for excarbation of psychiatric symptoms | Psychiatric disorders | Systematic Assessment | Re-hospitalization for worsening of psychiatric symptoms such as PTSD or bipolar disorder |
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| Hospitalization for pain | General disorders | Systematic Assessment |
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| Medical hospitalization | General disorders | Systematic Assessment | broken bones/fractures |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 6 Month Followup |
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| 9 Month Followup |
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| 12 Month Followup |
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| 6 Month Followup |
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| 9 Month Followup |
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| 12 Month Followup |
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| 6 Month Followup |
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| 9 Month Followup |
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| 1 Year Followup |
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| 9 Month Followup |
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| 12 Month Followup |
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| 6 Month Followup |
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| 9 Month Followup |
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| 12 Month Followup |
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