Self-Injurious BehaviorSTRIVeNCT05969080
Self-Injury Treatment and Recovery in Veterans
A study testing Treatment for Self-Injurious Behaviors and Treatment As Usual in people with Self-Injurious Behavior, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-Injurious Behavior
- What is being tested?
- Treatment for Self-Injurious Behaviors and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lifetime history of psychosis, mania, or hypomania
- Imminent risk for suicide/homicide warranting immediate intervention
- Unable/unwilling to complete study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Tate F Halverson, PhD, 919-286-0411 ext. 175415, Tate.Halverson@va.gov
Angela C Kirby, MS, (919) 286-0411 ext. 7456, angela.kirby@va.gov
About this study
Official title: A Brief Intervention to Reduce Nonsuicidal Self-Injury and Improve Functioning in Veterans
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.
Read the 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.
- Conditions
- Self-Injurious Behavior
- Being tested
- Treatment for Self-Injurious Behaviors, Treatment As Usual
- Keywords
- Self-Injurious Behavior, Veterans
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment for Self-Injurious BehaviorsBehavioural
Also called T-SIB
Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning.
Treatment As UsualOther
Also called TAU
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.
| Study group | Role | What they receive |
|---|---|---|
| T-SIB | Experimental | Participants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB. Receives: Behavioral: Treatment for Self-Injurious Behaviors |
| Treatment As Usual | Active comparator | 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. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after study enrollment begins
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.
Measured: End of treatment, about nine weeks after beginning the study
Secondary outcomes (1)
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.
Measured: End of treatment, about nine weeks after beginning the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 Oct 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-Injurious BehaviorStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tate F Halverson, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969080
- Sponsor's protocol ID
- D4803-W
- Other IDs
- 1745432
- Acronym
- STRIVe
- Status last verified
- Feb 2026
- First submitted
- 14 Jul 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention to Reduce Nonsuicidal Self-Injury and Improve Functioning in Veterans
- ClinicalTrials.gov ID
- NCT05969080
- Acronym / sponsor ID
- STRIVe / D4803-W
- Conditions
- Self-Injurious Behavior
- Keywords
- Self-Injurious Behavior, Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-SIB | Experimental | Behavioral: Treatment for Self-Injurious BehaviorsParticipants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB. |
| Treatment As Usual | Active comparator | Other: Treatment As UsualParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Lifetime history of psychosis, mania, or hypomania
- Imminent risk for suicide/homicide warranting immediate intervention
- Unable/unwilling to complete study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment for Self-Injurious BehaviorsAlso: T-SIBTreatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning. | Behavioural | T-SIB |
| Treatment As UsualAlso: TAUParticipants 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 |
Primary outcome
Feasibility as measured by number of participants enrolled
Time frame: 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.
Feasibility as measured rate of retention
Time frame: 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.
1 secondary outcome
Number of participants who report satisfaction with the T-SIB treatment
Time frame: End of treatment, about nine weeks after beginning the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tate F Halverson, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment for Self-Injurious Behaviors and Treatment As Usual in people with Self-Injurious Behavior, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tate F Halverson, PhD ((919) 286-0411 ext. 175415, Tate.Halverson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by number of participants enrolled (time frame: 2 years after study enrollment begins). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.