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Self-Injury Treatment and Recovery in Veterans (STRIVe)

Primary Purpose

Self-Injurious Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment for Self-Injurious Behaviors
Treatment As Usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-Injurious Behavior focused on measuring Self-Injurious Behavior, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Durham VA Medical Center, Durham, NC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T-SIB

Treatment As Usual

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Feasibility as measured by number of participants enrolled
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.
Feasibility as measured rate of retention
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

Number of participants who report satisfaction with the T-SIB treatment
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.

Full Information

First Posted
July 14, 2023
Last Updated
July 28, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05969080
Brief Title
Self-Injury Treatment and Recovery in Veterans
Acronym
STRIVe
Official Title
A Brief Intervention to Reduce Nonsuicidal Self-Injury and Improve Functioning in Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2025 (Anticipated)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Injurious Behavior
Keywords
Self-Injurious Behavior, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T-SIB
Arm Type
Experimental
Arm Description
Participants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB.
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment for Self-Injurious Behaviors
Other Intervention Name(s)
T-SIB
Intervention Description
Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning.
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Other Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility as measured by number of participants enrolled
Description
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.
Time Frame
2 years after study enrollment begins
Title
Feasibility as measured rate of retention
Description
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.
Time Frame
End of treatment, about nine weeks after beginning the study
Secondary Outcome Measure Information:
Title
Number of participants who report satisfaction with the T-SIB treatment
Description
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.
Time Frame
End of treatment, about nine weeks after beginning the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tate F Halverson, PhD
Phone
(919) 286-0411
Ext
175415
Email
Tate.Halverson@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Angela C Kirby, MS
Phone
(919) 286-0411
Ext
7456
Email
angela.kirby@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tate F Halverson, PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tate F Halverson, PhD
Phone
919-286-0411
Ext
175415
Email
Tate.Halverson@va.gov
First Name & Middle Initial & Last Name & Degree
Angela C Kirby, MS
Phone
(919) 286-0411
Ext
7456
Email
angela.kirby@va.gov
First Name & Middle Initial & Last Name & Degree
Tate F Halverson, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-Injury Treatment and Recovery in Veterans

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