Sleep Health Intervention for PTSD

Overseen By Corinne F Sigmund, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive problems, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sleep treatment for Veterans with PTSD and sleep difficulties. The goal is to determine if a modified version of an already successful sleep treatment benefits Veterans with PTSD. Participants will receive either the new treatment, TranS-C for PTSD (a sleep-focused therapy), or a sleep education program. Veterans with PTSD, sleep issues, and nightmares who are willing to participate in 8-12 treatment sessions may be suitable candidates. As an unphased trial, this study provides Veterans a unique opportunity to contribute to research that could enhance sleep treatments for PTSD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot be currently engaged in or planning to start a sleep-focused psychotherapy.

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

Research has shown that the TranS-C treatment, developed for PTSD and sleep problems, is safe. Studies indicate it reduces issues with daily functioning and mental health symptoms without causing major side effects. This treatment modifies an existing sleep program that already proves effective for most people. Adjustments for veterans with PTSD aim to enhance its benefits. Overall, the TranS-C treatment appears well-tolerated and safe for individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD-related sleep issues because they offer novel approaches compared to existing options like cognitive-behavioral therapy and medication. The TranS-C for PTSD treatment is unique in that it specifically integrates sleep-focused strategies to enhance overall mental health, potentially providing more comprehensive relief for PTSD symptoms. Meanwhile, the sleep psychoeducation control arm aims to improve understanding of sleep health, which could empower individuals with PTSD to better manage their symptoms through informed lifestyle changes. This trial could pave the way for more effective, holistic interventions for those struggling with PTSD and sleep disturbances.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research shows that TranS-C, a sleep program, successfully helps people sleep better. This trial will compare two treatments: the experimental TranS-C for PTSD, which participants in this trial may receive, and a sleep psychoeducation control. Early results suggest that the adapted TranS-C can lessen PTSD symptoms and improve sleep. Although data on this specific version for PTSD remains limited, TranS-C has proven effective for other groups. This suggests it could be promising for Veterans with PTSD-related sleep problems. ^{2 3 4 6 7}

Who Is on the Research Team?

Anne Richards, MD MPH

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD who struggle with sleep. It's designed to help those who haven't found relief from other treatments and are looking for a new approach specifically tailored to their needs.

Inclusion Criteria

CAPS 5 PTSD diagnosis; or CAPS 5 score >=25 in the absence of full criteria

CAPS-IV nightmare score >=4

I am a U.S. Military Veteran over 18 receiving care from the VA.

Exclusion Criteria

I am currently in, or will start, therapy for sleep issues soon.

No access to reliable internet service connected to a computer, iPad or similar device (telephone not adequate)

Inability or unwillingness to use a VA-approved videoconferencing platform and VA secure email

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TSC-PTSD intervention remotely using a video-conferencing platform, with a focus on nightmare, apnea, and insomnia modules

8-12 weeks

Remote sessions

Follow-up

Participants are monitored for the durability of treatment effects, including assessments of daytime functioning and sleep-related symptoms

6 months

Assessments at 3-month and 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Psychoeducation Control
• TranS-C for PTSD

Trial Overview The study tests TranS-C, a modified sleep treatment proven effective in the general population, now adapted for Veterans with PTSD. Participants will also receive Sleep Psychoeducation as a control comparison.

How Is the Trial Designed?

Group I: Arm 1: Experimental Experimental Treatment 1 Intervention

Participants receiving experimental TSC-PTSD treatment.

Group II: Arm 2: Active Control Active Control 1 Intervention

Participants receiving sleep psychoeducation control.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Patients with PTSD experience severe sleep disorders, with 87% reporting difficulty falling asleep and 88% suffering from nightmares, which significantly affect their daily lives.

There is a strong demand for targeted support for sleep disorders among PTSD patients, with 91% expressing interest in a therapeutic patient education program focused on improving sleep hygiene and managing nocturnal awakenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sleep and therapeutic education needs of military with PTSD. Remadi, M., Dinis, S., Bernard, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9193572/

Transcranial Magnetic Stimulation for Post-traumatic Stress ... Overall, TMS therapy has been suggested as an effective treatment in PTSD patients. Results of two meta-analysis showed that TMS therapy provides an overall ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06549049

Transdiagnostic Sleep Health Intervention for Veterans With ... The proposed study is a randomized, controlled clinical trial examining the effectiveness of a modified TranS-C intervention for Veterans with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032722009673

Research paper Treatment efficacy of tDCS and predictors ... This study highlighted the efficacy of frontal tDCS for the treatment of patients with PTSD and identified rumination and digit span as favorable predictive ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2815835

Virtual Reality and Transcranial Direct Current Stimulation ... Active tDCS delivered during VR exposure significantly improved self-reported PTSD symptoms, reduced measures of autonomic arousal, and improved social ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22921765/

Effectiveness of deep transcranial magnetic stimulation ... Combining brief script-driven exposure with DTMS can induce therapeutic effects in PTSD patients. A wide multi-center study is suggested to substantiate these ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9377521/

A randomized controlled trial of the Transdiagnostic ... For the primary outcomes, relative to UC-DT, TranS-C+UC was associated with reduction in functional impairment (b=−3.18, p=0.025, d=−0.58), general psychiatric ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0361923019306550

Transcranial direct current stimulation (tDCS) for post- ... Our results revealed that active tDCS over the bilateral DLPFC was effective in relieving the severity of PTSD symptoms at post-test and follow-up.