SuicideCLASP-VANCT01894841
Veterans Coping Long-term With Active Suicide
A study testing Coping Long Term with Active Suicide (CLASP) and Safety Assessment and Follow Up Evaluation in people with Suicide, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- Coping Long Term with Active Suicide (CLASP) and Safety Assessment and Follow Up Evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2014to 29 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- long-term psychiatric disorder
- diagnosis of borderline personality disorder
- cognitive impairment which would interfere with adequate participation in the project (MMSE <20)
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
Official title: Veterans Coping Long-Term With Suicide
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- Coping Long Term with Active Suicide (CLASP), Safety Assessment and Follow Up Evaluation
- Keywords
- depression, prevention, Veterans health
- Medical subject headings
- Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Long Term with Active Suicide (CLASP)Behavioural
6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management
Safety Assessment and Follow Up EvaluationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Coping Long Term with Active Suicide (CLASP); Other: Safety Assessment and Follow Up Evaluation |
| Safety Assessment and follow up Evaluation | Other | Treatment as usual plus enhanced monitoring. Receives: Other: Safety Assessment and Follow Up Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3, 6, 9, & 12 month post-hospitalization
Secondary outcomes (5)
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.
Measured: Baseline, 3, 6, 9, & 12 month follow up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, 3, 6, 9, & 12 month post-hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study start24 Feb 2014
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Butler Hospital
- Responsible party
- Sponsor
- Investigators
- Jennifer Marie Primack, PhD MA, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894841
- Sponsor's protocol ID
- IIR 13-026
- Acronym
- CLASP-VA
- Status last verified
- Jan 2020
- First submitted
- 3 Jul 2013
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37294816
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veterans Coping Long-Term With Suicide
- ClinicalTrials.gov ID
- NCT01894841
- Acronym / sponsor ID
- CLASP-VA / IIR 13-026
- Conditions
- Suicide
- Keywords
- depression, prevention, Veterans health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Butler Hospital
- Study start
- 24 Feb 2014 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLASP Intervention | Experimental | Behavioral: Coping Long Term with Active Suicide (CLASP), Other: Safety Assessment and Follow Up EvaluationA 6 month adjunctive intervention consisting of 3 individual meetings, one family session, and 11 brief phone contacts with patient and identified significant other. |
| Safety Assessment and follow up Evaluation | Other | Other: Safety Assessment and Follow Up EvaluationTreatment as usual plus enhanced monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- long-term psychiatric disorder
- diagnosis of borderline personality disorder
- cognitive impairment which would interfere with adequate participation in the project (MMSE <20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping Long Term with Active Suicide (CLASP)6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management | Behavioural | CLASP Intervention |
| Safety Assessment and Follow Up Evaluationenhanced 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 | Other | CLASP Intervention, Safety Assessment and follow up Evaluation |
Primary outcome
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior
Time frame: 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.
5 secondary outcomes
Changes in Beck Hopelessness Scale
Time frame: Baseline, 3, 6, 9, & 12 month follow up
Brief Symptom Inventory
Time frame: Baseline, 3, 6, 9, & 12 month follow up
World Health Organization Disability Assessment Schedule (WHODAS) II
Time frame: Baseline, 3, 6, 9, & 12 month follow ups
Treatment History Interview
Time frame: 3, 6, 9, & 12 month follow up
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity
Time frame: baseline, 3, 6, 9, & 12 month post-hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37294816Primack 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.
- Individual participant dataSharing planned: No
Related trials for Suicide
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Not yet recruitingPhase 1/2
Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
Suicide, Secure Firearm Storage
Recruiting
Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Depression and Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Marie Primack, PhD MA principal investigator
Providence VA Medical Center, Providence, RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Long Term with Active Suicide (CLASP) and Safety Assessment and Follow Up Evaluation in people with Suicide, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior (time frame: baseline, 3, 6, 9, & 12 month post-hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.