NCT05077514

Brief Summary

The study team conducted a randomized controlled clinical trial of 809 military service members who were at increased risk for suicide but not currently in behavioral health treatment. This study tested the effectiveness of a brief phone-based intervention (CBT-TS) aimed at changing military member's perceptions about behavioral health therapy. Participants completed five interviews over the course of one year to collect information about change in behavioral health symptoms and treatment utilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
809

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

March 1, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2019

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

6.9 years

First QC Date

October 1, 2021

Last Update Submit

October 13, 2021

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

  • Change in attitudes towards behavioral health treatment

    Change in mean score on the Perceptions about Services Scale (a measure of attitudes to treatment)

    1 month after intervention

  • Initiation to behavioral health treatment

    Number of participants who initiated behavioral health treatment

    6 months

Study Arms (2)

Group A

EXPERIMENTAL
Behavioral: Experimental: Cognitive Behavior Therapy

Group B

ACTIVE COMPARATOR
Behavioral: Active comparator: National Crisis Line

Interventions

Experimental: Cognitive Behavior TherapyBEHAVIORAL

Participants assigned to Group A were asked to participate in a talking session with a psychologist regarding thoughts about treatment. This session is designed to explore thoughts about behavioral health therapy for suicidality. The session was administered by phone, initially and again one month later. Participants discussed current functioning and their thoughts about seeking help with the goal of modifying thoughts about treatment. This phone session lasted approximately 45 to 60 minutes.

Group A
Active comparator: National Crisis LineBEHAVIORAL

Participants assigned to Group B received information about the VA's National Crisis Line.

Group B

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Must be in US Military current or previous after September 11, 2001
  • Must indicate suicidal ideation with in the past 2 weeks or have previous suicide attempt
  • Not currently receiving behavioral health treatment

You may not qualify if:

  • No suicide ideation or history of attempt
  • currently receiving behavioral health treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location

Related Publications (1)

  • Stecker T, Allan NP, Hoge C, Ashrafioun L, Conner KR. Efficacy of CBT for Treatment Seeking (CBT-TS) in Untreated Veterans and Service Members at Risk for Suicidal Behavior. J Gen Intern Med. 2023 Sep;38(12):2639-2646. doi: 10.1007/s11606-023-08129-z. Epub 2023 Mar 24.

    PMID: 36964422DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 14, 2021

Study Start

March 1, 2012

Primary Completion

January 14, 2019

Study Completion

January 14, 2019

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)