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 pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with 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. 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.

Is sleep education for insomnia in PTSD safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I), which includes sleep education, is generally considered safe for humans. It is widely recommended as a first-line treatment for insomnia and has been used in various settings without significant safety concerns. ^{1 2 3 4 5}

How does the Sleep Education for Insomnia in PTSD treatment differ from other treatments for this condition?

This treatment is unique because it focuses on sleep education specifically tailored for individuals with PTSD, addressing both insomnia and trauma-related sleep disturbances. Unlike standard cognitive behavioral therapy for insomnia (CBT-I), it may incorporate elements like imagery rehearsal therapy (IRT) for nightmares, making it more comprehensive for PTSD-related sleep issues. ^{3 5 6 7 8}

What data supports the effectiveness of the treatment for insomnia in PTSD?

Research shows that cognitive behavioral therapy for insomnia (CBT-I) is effective in reducing insomnia severity and improving sleep quality. It has been successfully used in various formats, such as workshops and self-help programs, and is beneficial for people with PTSD who often experience sleep problems. ^{1 2 3 7 9}

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

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. England 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. [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

Dissemination of CBTI to the non-sleep specialist: protocol development and training issues. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]

5. England 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. [2018]

6. England 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. [2020]

7. Germany 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. [2022]

8. United States 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. [2023]

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

Cognitive behavioral therapy for insomnia as a preparatory treatment for exposure therapy for posttraumatic stress disorder. [2022]