NCT01894841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

February 24, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 10, 2020

Completed
Last Updated

February 10, 2020

Status Verified

January 1, 2020

Enrollment Period

4.5 years

First QC Date

July 3, 2013

Results QC Date

November 7, 2019

Last Update Submit

January 28, 2020

Conditions

Keywords

depressionpreventionVeterans health

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Changes in Beck Hopelessness Scale

    Baseline, 3, 6, 9, & 12 month follow up

  • Brief Symptom Inventory

    Baseline, 3, 6, 9, & 12 month follow up

  • World Health Organization Disability Assessment Schedule (WHODAS) II

    Baseline, 3, 6, 9, & 12 month follow ups

  • Treatment History Interview

    3, 6, 9, & 12 month follow up

  • Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity

    baseline, 3, 6, 9, & 12 month post-hospitalization

Study Arms (2)

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.

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.

Other: Safety Assessment and Follow Up Evaluation

Interventions

6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management

CLASP Intervention

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

CLASP InterventionSafety Assessment and follow up Evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • long-term psychiatric disorder
  • diagnosis of borderline personality disorder
  • cognitive impairment which would interfere with adequate participation in the project (MMSE \<20)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SuicideDepression

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Jennifer Primack
Organization
Providence VAMC

Study Officials

  • Jennifer Marie Primack, PhD MA

    Providence VA Medical Center, Providence, RI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 10, 2013

Study Start

February 24, 2014

Primary Completion

August 29, 2018

Study Completion

August 29, 2018

Last Updated

February 10, 2020

Results First Posted

February 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations