STRIVe: Self-Injury Treatment and Recovery in Veterans

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05969080
Collaborator
(none)
40
1
2
25
1.6

Study Details

Study Description

Brief Summary

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Treatment for Self-Injurious Behaviors
  • Other: Treatment As Usual
N/A

Detailed Description

Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans. This treatment, known as the Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychoso ial functioning. A core component of T-SIB is functional assessment that identifies the antecedents and consequences of NSSI. This project will enhance T-SIB by using ecological momentary assessment (EMA) to conduct NSSI functional assessment in-vivo. EMA reduces retrospective recall bias and can increase engagement with therapeutic goals.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Brief Intervention to Reduce Nonsuicidal Self-Injury and Improve Functioning in Veterans
Anticipated Study Start Date :
Mar 1, 2025
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Mar 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: T-SIB

Participants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB.

Behavioral: Treatment for Self-Injurious Behaviors
Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning.
Other Names:
  • T-SIB
  • Active Comparator: Treatment As Usual

    Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.

    Other: Treatment As Usual
    Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.
    Other Names:
  • TAU
  • Outcome Measures

    Primary Outcome Measures

    1. Feasibility as measured by number of participants enrolled [2 years after study enrollment begins]

      All participants (N = 40) will need to be enrolled by the end of the second year of the study to consider the recruitment benchmark met.

    2. Feasibility as measured rate of retention [End of treatment, about nine weeks after beginning the study]

      Retention will be measured by the number of participants who complete at least six T-SIB treatment sessions. This benchmark will be considered meet if at least 2/3 of the 20 participants randomized to T-SIB complete at least 6 treatment sessions.

    Secondary Outcome Measures

    1. Number of participants who report satisfaction with the T-SIB treatment [End of treatment, about nine weeks after beginning the study]

      Participant satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, which higher scores indicating higher satisfaction. A cut score of 24 will be used such that if the CSQ-8 score exceeds 24, that patient is deemed to have been satisfied with the treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 years of age or older

    • Past service in the United States military

    • Nonsuicidal self-injury engagement on 2 occasions in past 30 days

    • Fluent in English

    • Able to provide voluntary informed consent

    Exclusion Criteria:
    • Lifetime history of psychosis, mania, or hypomania

    • Imminent risk for suicide/homicide warranting immediate intervention

    • Unable/unwilling to complete study procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Durham VA Medical Center, Durham, NC Durham North Carolina United States 27705-3875

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Tate F Halverson, PhD, Durham VA Medical Center, Durham, NC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT05969080
    Other Study ID Numbers:
    • D4803-W
    • 1745432
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 1, 2023