Sleep Education for Insomnia in PTSD

Overseen By Monica Kelly, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Substance use, Severe cardiovascular, others

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

Compensation: Varies

Number of Visits: 22

167 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how addressing sleep problems can aid PTSD (post-traumatic stress disorder) and improve heart health in older veterans. It combines Cognitive Processing Therapy (CPT) for PTSD with Cognitive Behavioral Therapy for Insomnia (CBT-I). The study aims to determine if resolving sleep issues can enhance sleep quality, PTSD symptoms, heart health, and overall life satisfaction. Veterans aged 50 or older, who have PTSD and insomnia and live near the VA Sepulveda Ambulatory Care Center, may qualify. As an unphased trial, this study provides veterans the chance to explore innovative treatments that could improve their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Since the study focuses on non-medication treatments, it's likely you can continue your current medications, but you should confirm with the study team.

What prior data suggests that this sleep education intervention is safe for older adults with PTSD?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), included in this trial, is generally safe. Studies have found that CBT-I can improve sleep without causing side effects, making it a well-tolerated alternative to sleep medications, which can sometimes have side effects.

CBT-I helps with various sleep issues, such as difficulty falling asleep or waking up during the night. Participants often report better sleep quality, and these benefits can last a long time. Additionally, CBT-I proves effective for individuals with PTSD, improving both sleep and PTSD symptoms.

Overall, CBT-I is a safe and effective method for addressing sleep problems, offering a good option for those seeking to improve sleep without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Sleep Education Intervention for insomnia in PTSD because it emphasizes a unique approach using behavioral sleep techniques. Unlike traditional treatments like medication or cognitive behavioral therapy, this intervention involves a manual-based program delivered in personalized, hour-long sessions over several weeks. This method focuses on changing sleep-related behaviors, which may offer a more sustainable and side-effect-free solution for individuals struggling with sleep issues due to PTSD. By tailoring the education to each person, this approach could provide more effective, long-term improvements in sleep quality.

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

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively treats sleep issues. Studies have found that CBT-I works as well as sleep medications but without the side effects. It improves sleep over time and reduces the risk of sleep problems returning. For individuals with PTSD, CBT-I can enhance sleep and help manage PTSD symptoms. This trial will evaluate the Behavioral Sleep Education Intervention, which incorporates CBT-I techniques, to determine its effectiveness in improving sleep and managing PTSD symptoms in older adults. ^{1 3 4 6 7}

Who Is on the Research Team?

Monica Kelly, PhD

Principal Investigator

UCLA / VA Greater Los Angeles

Are You a Good Fit for This Trial?

This trial is for Veterans aged 55+ with PTSD and insomnia, living within 50 miles of the VA Sepulveda Ambulatory Care Center. Participants must have used VHA services in the past year and be able to attend meetings. Those with severe diseases, unstable conditions, other sleep disorders or recent substance use recovery are excluded.

Inclusion Criteria

I have been diagnosed with PTSD.

Received care from a Veterans Health Administration (VHA) facility in the prior year

I am a Veteran over 50 years old living in the community.

Exclusion Criteria

I do not have severe heart or lung disease.

Active substance use or in recovery with less than 90 days of sobriety

I am unable to give consent for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Evaluation

Participants complete baseline evaluations including health questionnaires, blood pressure monitoring, glucose monitoring, and sleep pattern assessments

1 week

1 visit (in-person), home monitoring

PTSD Treatment

Participants receive Cognitive Processing Therapy (CPT) for PTSD

12 weeks

12 sessions (in-person)

Sleep Education Program

Participants are randomly assigned to one of two sleep education programs to address residual insomnia

5 weeks

5 sessions (in-person)

Follow-up

Participants are monitored for sleep, PTSD symptoms, cardiometabolic health, and quality of life

6 months

3 assessments (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Sleep Education Intervention
• General Sleep Education Intervention

Trial Overview The study tests non-medication treatments for insomnia after Cognitive Processing Therapy (CPT) for PTSD in older adults. It compares Behavioral Sleep Education against General Sleep Education to see if they improve sleep, PTSD symptoms, cardiometabolic health, and quality of life.

How Is the Trial Designed?

Group I: Behavioral Sleep Education Intervention Experimental Treatment 1 Intervention

Manual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

VA Office of Research and Development

Collaborator

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]

A pilot study involving 15 university staff members showed that an online cognitive behavioral therapy for insomnia (iCBT-I) training was well accepted and helpful, with 78% of participants reporting reduced sleep problems after the training.

Before the training, 89% of participants had sleep issues, but after completing the iCBT-I program, 56% achieved clinically significant improvement, and 44% were classified as healthy sleepers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modularized iCBT‑I self-learn training for university staff-prevention and early intervention in the SARS-CoV-2 crisis: A pilot study. Schlarb, AA., Fründ, JP., Kovacevic, T., et al.[2022]

Cognitive-behavioral therapy for insomnia (CBTi) was successfully used as a first-step treatment for a veteran with both insomnia and PTSD, leading to significant symptom relief after just six sessions.

The patient was able to transition to trauma-specific exposure therapy after CBTi, resulting in further reductions in both insomnia and PTSD symptoms, demonstrating the efficacy of this sequential treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia as a preparatory treatment for exposure therapy for posttraumatic stress disorder. Baddeley, JL., Gros, DF.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as the first-line treatment for insomnia, yet many patients in Europe still primarily receive hypnotic medications instead of CBT-I.

A Task Force proposed the creation of a European CBT-I Academy to standardize training and accreditation for health professionals, aiming to improve the delivery of CBT-I across Europe and align treatment practices with current guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Academy for Cognitive Behavioural Therapy for Insomnia: An initiative of the European Insomnia Network to promote implementation and dissemination of treatment. Baglioni, C., Altena, E., Bjorvatn, B., et al.[2020]

A study involving 210 adults with insomnia compared three interventions: a cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI, and sleep hygiene education (SHE). All interventions significantly improved insomnia severity, anxiety, depressive symptoms, and quality of life, but there were no significant differences in effectiveness between the groups.

Self-help CBTI emerged as a preferred option in the stepped-care model for insomnia due to its comparable efficacy and adherence rates to workshop-based interventions, while being more accessible and requiring fewer resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial. Wong, KY., Chung, KF., Au, CH.[2021]

Cognitive Behavioral Therapy for Insomnia (CBTI) is effective, but its widespread use is limited by a shortage of qualified practitioners, prompting the development of a targeted training program for mental health clinicians in the Veterans Health Administration (VHA).

The training program was designed to be competency-based and pragmatic, accommodating the busy schedules of licensed therapists while ensuring they receive essential knowledge about sleep science and comorbid conditions, thus enhancing their ability to deliver CBTI effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of CBTI to the non-sleep specialist: protocol development and training issues. Manber, R., Carney, C., Edinger, J., et al.[2022]

In a case-series study involving 48 chronic insomnia patients, an eight-session cognitive-behavioral therapy for insomnia (CBTi) protocol led to significant improvements in various sleep metrics, including sleep onset latency and insomnia severity, even while patients continued using sleep medications.

The study found a notable reduction in the use of sleep medications from 87.5% before treatment to 54% after treatment, indicating that CBTi can be effective without requiring patients to stop their medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy of insomnia: a clinical case series study of patients with co-morbid disorders and using hypnotic medications. Dolan, DC., Taylor, DJ., Bramoweth, AD., et al.[2018]

In a study of 31 Australian veterans with PTSD, both cognitive behavioral therapy for insomnia (CBT-I) and CBT-I combined with imagery rehearsal therapy (IRT) showed improvements in sleep quality over time, but neither treatment was significantly more effective than the other.

Despite some improvements, participants still reported poor sleep quality after treatment, suggesting that further optimization of these therapies is needed for veterans experiencing trauma-related sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic sleep disturbances in veterans: A pilot randomized controlled trial of cognitive behavioral therapy for insomnia and imagery rehearsal therapy. Prguda, E., Evans, J., McLeay, S., et al.[2023]

A single 4-hour group workshop on cognitive behavioral treatment for insomnia (CBT-I) significantly improved insomnia symptoms in 45 participants, with Insomnia Severity Index scores dropping from an average of 20.09 to 11.89 after one month.

Participants also reported a reduction in sleep aid use, with 80% indicating better sleep quality and 20% achieving remission of insomnia, highlighting the effectiveness of this accessible treatment format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. Okun, ML., Glidewell, RN.[2023]

Citations

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Cognitive-Behavioral Therapy for Insomnia: An Effective ... CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve ...

2. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1649937.pdf

Cognitive Behavioral Therapy for Insomnia With Prolonged ... This study compared the efficacy of integrated cognitive behavioral therapy for insomnia (CBT-I) and prolonged exposure (PE; CBTI-PE) therapy to ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/15402002.2025.2529856

Evaluating the Effectiveness of Cognitive Behavioral ... Delivering Cognitive Behavioral Therapy for insomnia (CBT-I) in schools may be an effective way to reach adolescents with poor sleep. This ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000107

Cognitive behavioral therapy for insomnia in patients with ... CBT-I is an effective treatment for patients with insomnia and a comorbid mental disorder, especially depression, PTSD and alcohol dependency.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8986

Behavioral and psychological treatments for chronic insomnia ... This guideline establishes clinical practice recommendations for the use of behavioral and psychological treatments for chronic insomnia disorder in adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3900619/

Cognitive Behavioral Therapy for Insomnia in Posttraumatic ... CBT-I treatment resulted in improvements in sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, and sleep quality on subjective ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/42/NCT02774642/Prot_000.pdf

Integrated CBT-I and PE on Sleep and PTSD Outcomes ( ... Importantly, there is increasing evidence that insomnia interferes with the mechanisms of PE including safety learning, habituation, emotional coping, emotional ...