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Behavioral Intervention
Brief Intervention for Self-Harm in Veterans (STRIVe Trial)
N/A
Waitlist Available
Led By Tate F Halverson, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment, about nine weeks after beginning the study
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a therapy called T-SIB to help Veterans who hurt themselves on purpose. The therapy teaches healthier ways to cope and uses real-time tracking to understand and manage triggers. Veterans are targeted because they have higher rates of self-injury, which can lead to serious mental health problems.
Who is the study for?
This trial is for Veterans aged 18 or older who have harmed themselves on purpose at least twice in the past month without suicidal intent. Participants must be fluent in English and able to consent to the study. Those with a history of psychosis, mania, hypomania, or current high risk of suicide or homicide are not eligible.
What is being tested?
The study is testing a brief intervention designed to reduce self-harm behaviors and improve psychosocial functioning among Veterans. It will compare this new approach against the usual treatment methods typically offered for self-injury.
What are the potential side effects?
As this trial involves psychological interventions rather than medication, traditional side effects are not applicable. However, participants may experience emotional discomfort when discussing self-injurious behavior.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of treatment, about nine weeks after beginning the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment, about nine weeks after beginning the study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility as measured by number of participants enrolled
Feasibility as measured rate of retention
Secondary study objectives
Number of participants who report satisfaction with the T-SIB treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: T-SIBExperimental Treatment1 Intervention
Participants randomized to the Treatment for Self-Injurious Behaviors (T-SIB) condition will receive nine sessions of T-SIB.
Group II: Treatment As UsualActive Control1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for self-harm, particularly brief psychotherapy using behavioral and cognitive techniques, work by addressing the underlying psychological factors that contribute to self-injurious behaviors. Behavioral techniques, such as skills training, help patients manage distress and reduce impulsive actions.
Cognitive techniques aim to alter negative thought patterns that lead to self-harm. These mechanisms are essential for self-harm patients as they improve emotional regulation and enhance psychosocial functioning, thereby reducing the frequency and severity of self-harm incidents.
Psychosocial versus pharmacological treatments for deliberate self harm.
Psychosocial versus pharmacological treatments for deliberate self harm.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,773 Total Patients Enrolled
Tate F Halverson, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or do not want to follow the study's required procedures.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment As Usual
- Group 2: T-SIB
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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