Behavioral Treatments for Post-Traumatic Stress Disorder

(REST Trial)

Overseen By Andrea A Massa, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Pregnant, Prisoner, Severe injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to treat stress and depression after car accidents using behavioral therapy delivered through telehealth. Researchers are testing two methods: one focuses on better sleep habits (Brief Behavioral Treatment for Insomnia, or BBTI), and the other on muscle relaxation (Progressive Muscle Relaxation Training, or PMRT). People who recently experienced a car accident and are at risk for post-traumatic stress disorder (PTSD), but are not severely injured, might be suitable candidates. Participants attend four remote therapy sessions using their smartphones. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could improve well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've had a change in psychiatric medication within a month before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Brief Behavioral Treatment for Insomnia (BBTI) is generally easy for people to handle. For example, research indicates that veterans who received BBTI experienced better sleep and mood without major side effects, suggesting that BBTI is safe to use.

Similarly, research on Progressive Muscle Relaxation Training (PMRT) shows it is safe. Studies report no significant health problems during or after the sessions, indicating that PMRT is considered low-risk.

Both treatments have been used in other studies with few safety concerns, providing reassurance about their use in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for PTSD because they offer non-pharmaceutical options to manage symptoms. Brief Behavioral Treatment for Insomnia (BBTI) is unique as it provides insomnia relief through a short, focused telehealth approach, enhancing sleep without medication. Progressive Muscle Relaxation Training (PMRT) offers another drug-free path, teaching individuals to reduce tension and stress by systematically relaxing muscles, which can be especially beneficial for those experiencing hyperarousal symptoms related to PTSD. Both methods are delivered via telehealth, making them accessible and convenient for participants, unlike traditional therapies that often require in-person sessions.

What evidence suggests that this trial's treatments could be effective for post-traumatic stress disorder?

This trial will compare Brief Behavioral Treatment for Insomnia (BBTI) with Progressive Muscle Relaxation Training (PMRT) for their effectiveness in treating PTSD. Studies have shown that BBTI can greatly reduce trauma-related nightmares and improve sleep in people with PTSD, leading to better sleep and fewer daytime PTSD symptoms. In contrast, PMRT has been somewhat successful in helping disaster victims manage post-traumatic symptoms, but it did not have the same effect on trauma-related nightmares as BBTI. This trial studies both treatments for their potential to ease symptoms of PTSD and depression after traumatic events like car accidents. ^{1 2 3 6 7}

Who Is on the Research Team?

Samuel McLean, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals at high risk of developing posttraumatic stress and depressive symptoms after a motor vehicle collision. It's designed to test if telehealth-delivered therapy can help with recovery.

Inclusion Criteria

Has an email and mailing address

Owns a smartphone compatible with iOS or Android, has not experienced service interruption due to non-payment in the past year, and has maintained the same phone number for at least one year

Meets PTSD risk score criteria (score of ≥ 16 on the PTSD risk stratification tool)

Exclusion Criteria

Pregnant

Prisoner or in police custody

Severely injured (e.g., severely broken bones) as a result of the MVC that, in the opinion of the investigator, may impact PTSD trajectories

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive four sessions of telehealth-delivered brief behavioral treatment for insomnia (BBTI) or progressive muscle relaxation training (PMRT)

4 weeks

4 sessions (telehealth)

Follow-up

Participants are monitored for changes in PTSD, somatic, depressive, and pain symptoms over time

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief Behavioral Treatment for Insomnia (BBTI)
• Progressive Muscle Relaxation Training (PMRT)

Trial Overview The trial is testing two types of therapy delivered via telehealth: Brief Behavioral Treatment for Insomnia (BBTI) and Progressive Muscle Relaxation Training (PMRT), to see if they can prevent PTSD and depression after trauma.

How Is the Trial Designed?

Group I: Brief Behavioral Treatment for Insomnia (BBTI) Experimental Treatment 1 Intervention

Four sessions of telehealth-delivered brief behavioral treatment for insomnia

Group II: Progressive Muscle Relaxation Training (PMRT) Active Control 1 Intervention

Four sessions of telehealth-delivered progressive muscle relaxation training

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Heart and Armor Foundation

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9243281/

Brief behavioral treatment for insomnia decreases trauma ... We found that BBTI significantly reduced trauma-related nightmares from baseline to posttreatment, whereas progressive muscle relaxation therapy did not.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05780177?draw=2&rank=1

Brief Behavioral Treatment for Insomnia in Veterans With ... The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals include assessing ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05780177

Brief Behavioral Treatment for Insomnia in Veterans With ... The primary outcome for the trial will be psychosocial functioning, with insomnia severity serving as the secondary outcome. Additional goals ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796706001008

Effects of a brief behavioral treatment for PTSD-related ... A very brief behavioral intervention targeting post-traumatic nightmares and insomnia was associated with significant improvements in sleep and daytime PTSD ...

5. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id42060.pdf

Cognitive Behavioral Therapy for Insomnia in Posttraumatic ... Conclusions: Cognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo.

6. academic.oup.com academic.oup.com/sleep/article/44/3/zsaa205/5918478

Brief behavioral treatment for insomnia improves psychosocial ... Veterans who received BBTI improved and maintained gains in psychosocial functioning, insomnia, and mood.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722925000999

Treatment Development Report of an Intensive Group ... Open pilot evaluation suggests that participants experienced reductions in PTSD symptoms, insomnia, and nightmares, and were satisfied with the ...