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

182 Participants Needed

Trial Summary

What is the purpose of this trial?

Sleep disturbance is a major problem in Veterans with posttraumatic stress disorder (PTSD). This study will test a version of a sleep treatment that's been shown to be effective in the general population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.

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.

What evidence supports the effectiveness of the treatment Sleep Psychoeducation Control, TranS-C for PTSD?

Research shows that sleep therapies like cognitive behavioral therapy for insomnia, psychoeducation, and relaxation have been effective in treating sleep problems, which are common in PTSD. Improving sleep can help reduce PTSD symptoms and improve overall quality of life. ^{1 2 3 4 5}

Is the Sleep Health Intervention for PTSD safe for humans?

The research suggests that sleep therapies, including psychoeducation and relaxation, have been effective and safe for treating insomnia, which is often linked to PTSD. These therapies can improve sleep quality and may help manage PTSD symptoms without significant safety concerns. ^{2 3 4 5 6}

How is the Sleep Psychoeducation Control, TranS-C for PTSD treatment different from other PTSD treatments?

This treatment is unique because it specifically targets sleep disturbances, which are common in PTSD, by using sleep psychoeducation and cognitive-behavioral techniques to improve sleep quality and efficiency, potentially enhancing the effectiveness of other PTSD therapies. ^{1 3 4 7 8}

Research Team

Anne Richards, MD MPH

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

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

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

I am willing to attend 8-12 sessions to improve my sleep.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Investigating the link between subjective sleep quality, symptoms of PTSD, and level of functioning in a sample of trauma-affected refugees. [2021]

2. France pubmed.ncbi.nlm.nih.gov

Evaluation of sleep and therapeutic education needs of military with PTSD. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Sleep problems in active duty military personnel seeking treatment for posttraumatic stress disorder: presence, change, and impact on outcomes. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Sleep disturbances as the hallmark of PTSD: where are we now? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Bidirectional associations between daily PTSD symptoms and sleep disturbances: A systematic review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled study examining the role of rapid eye movement sleep in fear-related mechanisms: rapid eye movement fragmentation and fear inhibition in adults with insomnia disorders before and after cognitive behavioral therapy for insomnia. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Correlates of daytime sleepiness in patients with posttraumatic stress disorder and sleep disturbance. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

Sleep efficiency predicts improvements in fear extinction and PTSD symptoms during prolonged exposure for veterans with comorbid insomnia. [2023]