NCT05272176

Brief Summary

Veterans Coordinated Community Care (3C) Study will recruit 850 Veterans at risk for suicide post inpatient hospitalization. Each participant will be randomly assigned to treatment as usual (TAU) or TAU plus the Coping Long Term with Active Suicide Program (CLASP), with follow-up for 6 months after discharge. Outcomes include suicide-related behaviors (including deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts) and suicidal ideation and functioning.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
active not recruiting

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

Study Progress99%
Jan 2022Jun 2026

Study Start

First participant enrolled

January 11, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

January 27, 2022

Last Update Submit

January 13, 2026

Conditions

Keywords

VeteransSuicide PreventionBehavioral SymptomsCase Management

Outcome Measures

Primary Outcomes (2)

  • Veterans Affairs Healthcare System (VAHS) health and administrative records on suicide related behaviors

    Suicide related behaviors that include deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts.

    6 months after discharge

  • 3C Suicide Outcome Measure

    Study specific aggregate measure (3C Suicide Outcome Measure) containing selected items from the Columbia-Suicide Severity Rating Scale (C-SSRS), Self-Injurious Thoughts and Behaviors Interview (SITBI), and Suicidal Behaviors Questionnaire (SBQ).

    6 months after discharge

Secondary Outcomes (2)

  • Veterans Affairs Healthcare System (VAHS) health and administrative records on suicidal ideation and functioning

    6 months after discharge

  • 3C Suicidal Ideation and Functioning Outcome Measure

    6 months after discharge

Study Arms (2)

Coping Long Term with Active Suicide Program (CLASP)

EXPERIMENTAL

The CLASP intervention is an adjunctive, telehealth-based behavioral intervention designed to reduce suicidal behavior among individuals at high risk for suicide going through periods of transition. CLASP is designed to intervene on four risk factor targets: ongoing treatment engagement, problem-solving, social and family support, and hopelessness. In addition to these general factors, the CLASP provider also has the flexibility to identify and target certain "patient-specific" risk factors (e.g., substance misuse) for intervention. CLASP will begin after completion of the baseline assessment, and will continue for 6 months post-discharge. CLASP will be comprised of: a) 3 initial sessions while participants are still inpatients (can occur post-discharge if needed); b) 12 brief telehealth sessions over 6-months post-discharge; c) 6 brief SO telehealth sessions.

Behavioral: Coping Long Term with Active Suicide Program (CLASP)

Treatment As Usual (TAU)

NO INTERVENTION

Treatment As Usual (TAU) consists of unrestricted treatment provided as part of routine care in the Veterans Health Administration (VHA) following inpatient hospitalization. Study staff will provide no additional treatment in this arm.

Interventions

Telehealth-based case management intervention designed to reduce suicidal behavior among individuals at high risk for suicide across the transition from inpatient hospitalization to the community.

Coping Long Term with Active Suicide Program (CLASP)

Eligibility Criteria

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

You may qualify if:

  • Inpatient Veteran at high-risk for post-discharge suicide (as flagged by the study's validated prediction model)
  • years or older
  • Access to a telephone after discharge.

You may not qualify if:

  • Impaired decision-making capacity
  • Limited or no English language proficiency
  • Terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

VA Boston Healthcare System

Boston, Massachusetts, 02301, United States

Location

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

VA St. Louis Health Care System

St Louis, Missouri, 63125, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Tennessee Valley Health Care System

Murfreesboro, Tennessee, 37129, United States

Location

VA North Texas Healthcare System

Dallas, Texas, 75216, United States

Location

Related Publications (4)

  • Miller IW, Gaudiano BA, Weinstock LM. The Coping Long Term with Active Suicide Program: Description and Pilot Data. Suicide Life Threat Behav. 2016 Dec;46(6):752-761. doi: 10.1111/sltb.12247. Epub 2016 Apr 2.

    PMID: 27038050BACKGROUND
  • Kessler RC, Bauer MS, Bishop TM, Demler OV, Dobscha SK, Gildea SM, Goulet JL, Karras E, Kreyenbuhl J, Landes SJ, Liu H, Luedtke AR, Mair P, McAuliffe WHB, Nock M, Petukhova M, Pigeon WR, Sampson NA, Smoller JW, Weinstock LM, Bossarte RM. Using Administrative Data to Predict Suicide After Psychiatric Hospitalization in the Veterans Health Administration System. Front Psychiatry. 2020 May 6;11:390. doi: 10.3389/fpsyt.2020.00390. eCollection 2020.

    PMID: 32435212BACKGROUND
  • Miller IW, Camargo CA Jr, Arias SA, Sullivan AF, Allen MH, Goldstein AB, Manton AP, Espinola JA, Jones R, Hasegawa K, Boudreaux ED; ED-SAFE Investigators. Suicide Prevention in an Emergency Department Population: The ED-SAFE Study. JAMA Psychiatry. 2017 Jun 1;74(6):563-570. doi: 10.1001/jamapsychiatry.2017.0678.

    PMID: 28456130BACKGROUND
  • Weinstock LM, Bishop TM, Bauer MS, Benware J, Bossarte RM, Bradley J, Dobscha SK, Gibbs J, Gildea SM, Graves H, Haas G, House S, Kennedy CJ, Landes SJ, Liu H, Luedtke A, Marx BP, Miller A, Nock MK, Owen RR, Pigeon WR, Sampson NA, Santiago-Colon A, Shivakumar G, Urosevic S, Kessler RC. Design of a multicenter randomized controlled trial of a post-discharge suicide prevention intervention for high-risk psychiatric inpatients: The Veterans Coordinated Community Care Study. Int J Methods Psychiatr Res. 2024 Dec;33(4):e70003. doi: 10.1002/mpr.70003.

MeSH Terms

Conditions

SuicideSuicide PreventionBehavioral Symptoms

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavior

Study Officials

  • Lauren Weinstock, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 27, 2022

First Posted

March 9, 2022

Study Start

January 11, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified study data will be made available through the Inter-university Consortium for Political and Social Research (ICPSR) after the study has ended.

Time Frame
De-identified data will become available after the study has ended.
Access Criteria
De-identified data are made available to users at ICPSR member institutions.

Locations