167 Participants Needed

Sleep Education for Insomnia in PTSD

MK
Overseen ByMonica Kelly, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.13467

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.24789

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.

Research Team

MK

Monica Kelly, PhD

Principal Investigator

UCLA / VA Greater Los Angeles

Eligibility Criteria

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.
See 2 more

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.
See 4 more

Timeline

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Behavioral Sleep Education InterventionExperimental Treatment1 Intervention
Manual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions.

Find a Clinic Near You

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+

Findings from Research

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

References

Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial. [2021]
Evaluation of sleep and therapeutic education needs of military with PTSD. [2023]
Dissemination of CBTI to the non-sleep specialist: protocol development and training issues. [2022]
Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]
Cognitive-behavioral therapy of insomnia: a clinical case series study of patients with co-morbid disorders and using hypnotic medications. [2018]
The European Academy for Cognitive Behavioural Therapy for Insomnia: An initiative of the European Insomnia Network to promote implementation and dissemination of treatment. [2020]
Modularized iCBT‑I self-learn training for university staff-prevention and early intervention in the SARS-CoV-2 crisis: A pilot study. [2022]
Posttraumatic sleep disturbances in veterans: A pilot randomized controlled trial of cognitive behavioral therapy for insomnia and imagery rehearsal therapy. [2023]
Cognitive behavioral therapy for insomnia as a preparatory treatment for exposure therapy for posttraumatic stress disorder. [2022]
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