40 Participants Needed

Brief Intervention for Self-Harm in Veterans

(STRIVe Trial)

TF
AC
Overseen ByAngela C Kirby, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment for veterans who have engaged in nonsuicidal self-injury, which involves intentional self-harm without the intent to end life. The goal is to determine if a brief intervention, specifically the Treatment for Self-Injurious Behaviors, can reduce self-harming behaviors and enhance daily life. Participants will be randomly assigned to receive either the new treatment or standard mental health referrals. Veterans who have intentionally harmed themselves at least twice in the last month and can communicate in English may be suitable for this study. As an unphased trial, this study provides veterans with a unique opportunity to contribute to important research that could improve treatment options for self-injury.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this brief intervention is safe for Veterans?

Research has shown that treatments for self-harming behaviors, such as the Treatment for Self-Injurious Behaviors (T-SIB), have been tested for safety and effectiveness. One study with 173 teenagers found that treatments using Dialectical Behavior Therapy for Adolescents (DBT-A) significantly reduced self-harm and nonsuicidal self-injury (NSSI) without major side effects, indicating the treatment is generally well-tolerated.

Another review of various therapies that consider social and psychological factors found that these treatments often lead to fewer self-harm incidents. Although most studies focus on young people, these results provide some reassurance about safety.

While the specific treatment in this trial, T-SIB, isn't detailed in these sources, the general approach has proven to be safe and effective. This suggests that participants can expect a treatment that is both safe and potentially helpful in reducing self-harming behaviors.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for Treatment for Self-Injurious Behaviors (T-SIB) because it offers a structured therapeutic approach specifically tailored for veterans dealing with self-harm, a group that often has unique challenges and needs. Unlike standard treatments that may primarily focus on medication or general therapy, T-SIB consists of nine targeted sessions designed to directly address self-injurious behaviors. This method offers the potential for more immediate, focused support, which could lead to quicker and more sustainable improvement in participants.

What evidence suggests that this trial's treatments could be effective for reducing self-injurious behaviors in Veterans?

Research shows that people sometimes harm themselves to cope with their emotions. In this trial, participants will be randomized to receive either the Treatment for Self-Injurious Behaviors (T-SIB) program or Treatment As Usual. The T-SIB program has shown promise in managing these actions. Studies have found that similar programs can reduce self-harm by teaching skills for better emotional control. Early results suggest that T-SIB can decrease the frequency of self-injury and improve overall mental health. This treatment aims to help Veterans by addressing the unique challenges they face with self-injury.13678

Who Is on the Research Team?

TF

Tate F Halverson, PhD

Principal Investigator

Durham VA Medical Center, Durham, NC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Fluent in English
Past service in the United States military
Able to provide voluntary informed consent
See 1 more

Exclusion Criteria

I cannot or do not want to follow the study's required procedures.
Lifetime history of psychosis, mania, or hypomania
Imminent risk for suicide/homicide warranting immediate intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nine sessions of Treatment for Self-Injurious Behaviors (T-SIB) to reduce NSSI and improve psychosocial functioning

9 weeks
9 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Treatment As Usual
  • Treatment for Self-Injurious Behaviors
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: T-SIBExperimental Treatment1 Intervention
Group II: Treatment As UsualActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Citations

Treatments for Self-Injurious Thoughts and Behaviors in ...Research supports the theory that affect regulation is a core function of self-injurious behaviors, such that individuals engage in self-harm to alleviate ...
The effectiveness of the TaySH (Transitional Age Youth ...... Treatment for Self-Injurious Behaviors program (T-SIB) . More recently, a new treatment program, Cut the Cut (CTC) , has been published as a pilot study ...
Efficacy of interventions for suicide and self-injury in ...The treatment of suicide and self-injurious behaviors in children and adolescents. Curr. Treat. Options Psychiatry 7, 39–52 (2020). Article ...
Nonsuicidal Self-Injury Among Individuals Seeking TreatmentThe Self-Injurious Thoughts and Behaviors Interview was used to assess NSSI history, which previously showed strong construct validity (κ range, ...
Effects of interventions for self-harm in children and ...... self-injurious thoughts and behaviors: results from a randomized trial. ... Asarnow JR, Mehlum L (2023) Practitioner review: treatment for ...
Evidence-Based Psychosocial Treatments for Self-Injurious ...To review the current evidence base of psychosocial treatments for suicidal and nonsuicidal self-injurious thoughts and behaviors (SITBs) in youth.
Treatment for Non-Suicidal Self-Injury in Young Adults ...The purpose of this study is to investigate an intervention specifically for non-suicidal self-injury (NSSI) in young adults. The goal of this 9-session ...
Exploring effective interventions to reduce Self-Harm ...Overall, the seven studies analyzed found that the seven intervention models tested reduced adolescent self-harm and outcomes (Table 2). Table 2. The outcome of ...
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