Trauma-Informed CBT-I for PTSD-Related Insomnia

Overseen By Scott E Krahl, PhD MA BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance abuse, Pregnancy, Sleep apnea, others

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

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment and the psychoeducational intervention is modeled after usual care in a VA Women's Mental Health Clinic. The study objectives are to: 1) Iteratively refine the structure and materials of trauma-informed CBT-I in preparation for a pilot trial, 2) Pilot test the effects of trauma-informed CBT-I on PTSD treatment readiness and engagement in a sample of women Veterans, and 3) Examine potential mechanisms underlying variations in PTSD treatment readiness and engagement over time among women Veterans. Women Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Then Veterans who meet all eligibility criteria will be randomly assigned to trauma-informed CBT-I (n=25) or the psychoeducational intervention (n=25). Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=50) will have 2 follow-up assessments (post-treatment and 3-months). The follow-up assessments will collect information on PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Chart reviews will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (treatment engagement measure). Qualitative interviews will be conducted to identify mechanisms underlying PTSD treatment engagement.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your healthcare provider.

What data supports the effectiveness of the treatment Trauma-Informed CBT-I for PTSD-Related Insomnia?

Research shows that using cognitive-behavioral therapy for insomnia (CBT-I) can help improve sleep and reduce PTSD symptoms, making it easier for patients to engage in further PTSD treatments. Studies also indicate that treating insomnia alongside PTSD can lead to better overall outcomes than treating PTSD alone. ^{1 2 3 4 5}

Is Trauma-Informed CBT-I safe for treating PTSD-related insomnia?

Research suggests that Cognitive Behavioral Therapy for Insomnia (CBT-I), including its trauma-informed versions, is generally safe for individuals with PTSD and insomnia. Studies have shown that it can improve sleep and PTSD symptoms without significant safety concerns. ^{1 2 3 6 7}

How is the Trauma-Informed CBT-I treatment for PTSD-related insomnia different from other treatments?

Trauma-Informed CBT-I is unique because it combines cognitive behavioral therapy for insomnia (CBT-I) with trauma-focused psychoeducation, specifically addressing both sleep disturbances and PTSD symptoms. This approach prepares patients for further PTSD treatments by improving sleep and reducing PTSD symptoms, unlike standard treatments that may not address both issues simultaneously. ^{1 2 8 9 10}

Research Team

Gwendolyn C Carlson, PhD

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Eligibility Criteria

This trial is for women Veterans over 18 who have PTSD and insomnia, received care from VAGLAHS in the past year, and can consent to participate. It's not for those with severe health/emotional issues, drug/alcohol problems, prior CBT-I therapy or extensive PTSD treatment, recent pregnancy, untreated sleep apnea, unstable housing or medical conditions, or remission of symptoms.

Inclusion Criteria

I am a woman veteran over 18 and live in the community.

Received care from VAGLAHS

I have trouble sleeping.

Exclusion Criteria

Pregnant or pregnant within 6 months of study

I cannot read, write, or communicate in English.

Reported health or emotional problems, or use of drugs or alcohol that would make it difficult for them to participate in this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment includes measures of PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms

1 week

1 visit (in-person)

Treatment

Participants receive either trauma-informed CBT-I or a psychoeducational intervention in 5 one-on-one sessions

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms

3 months

2 visits (in-person)

Extended Follow-up

Chart reviews and qualitative interviews conducted to assess PTSD treatment engagement and identify facilitators and barriers

6 months post-treatment

Treatment Details

Interventions

• PTSD Psychoeducation
• Trauma-Informed CBT-I

Trial Overview The study compares trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) with a psychoeducational intervention in treating insomnia and improving PTSD treatment readiness among women Veterans. Participants will be randomly assigned to one of the two treatments which consist of five sessions each.

Participant Groups

Group I: Trauma-Informed CBT-I Experimental Treatment 1 Intervention

This intervention includes trauma-informed adaptations to standard treatment for insomnia, CBT-I

Group II: PTSD Psychoeducation Active Control 1 Intervention

This intervention includes psychoeducation about PTSD symptoms modeled after usual care in a VA Women's Health Clinic.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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]

This study involves 222 U.S. military personnel and veterans with PTSD, insomnia, and nightmares, aiming to determine the most effective treatment sequence between Cognitive-Behavioral Therapy for Insomnia and Nightmares (CBT-I&N) and Cognitive Processing Therapy (CPT) over 12 weeks.

The research seeks to address the gap in treatment for individuals suffering from all three conditions, as current therapies do not adequately target both PTSD symptoms and sleep disturbances, potentially improving overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial. Taylor, DJ., Pruiksma, KE., Mintz, J., et al.[2021]

A pilot study involving 93 U.S. military personnel found that combining cognitive behavioral therapy for insomnia and nightmares (CBT-I&N) with cognitive processing therapy (CPT) for PTSD led to significantly greater improvements in PTSD symptoms, insomnia, sleep efficiency, and nightmares compared to CPT alone.

Participants who received CBT-I&N after CPT showed even larger improvements in PTSD symptoms and sleep efficiency, suggesting that addressing insomnia and nightmares alongside PTSD treatment can provide meaningful benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of comorbid sleep disorders and posttraumatic stress disorder in U.S. active duty military personnel: A pilot randomized clinical trial. Taylor, DJ., Pruiksma, KE., Mintz, J., et al.[2023]

A five-session cognitive-behavioral treatment for insomnia was effective in improving sleep quality for 4 out of 5 patients who had PTSD and still experienced insomnia after standard CBT for PTSD.

The treatment led to significant improvements in various subjective sleep measures, indicating that addressing insomnia is crucial for comprehensive PTSD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of residual insomnia after CBT for PTSD: case studies. DeViva, JC., Zayfert, C., Pigeon, WR., et al.[2022]

Integrating cognitive-behavioral treatment for insomnia (CBT-I) with prolonged exposure therapy (PE) in the 2NITE protocol showed significant improvements in PTSD symptoms and sleep quality among 12 veterans, indicating a promising approach for treating both conditions simultaneously.

Participants reported high satisfaction with the 2NITE protocol, and measurable outcomes included a notable decrease in PTSD symptoms and insomnia severity, along with improved sleep efficiency and total sleep time, suggesting that addressing insomnia may enhance overall treatment effectiveness for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting cognitive-behavioral therapy for insomnia integrated with prolonged exposure. Colvonen, PJ., Drummond, SPA., Angkaw, AC., et al.[2023]

In a preliminary open clinical trial with 10 combat veterans, a combined treatment of cognitive-behavioral therapy for insomnia and exposure therapy showed promising improvements in sleep quality and reduction of nightmares associated with PTSD.

Participants engaged in 10 sessions of therapy and maintained daily diaries, indicating that this approach may effectively address sleep disturbances in PTSD, though further controlled studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined group treatment for nightmares and insomnia in combat veterans: a pilot study. Swanson, LM., Favorite, TK., Horin, E., et al.[2022]

Recent studies show that while treatments for PTSD can reduce symptoms and nightmares, they do not effectively resolve insomnia or obstructive sleep apnea (OSA), indicating a need for targeted sleep disorder interventions.

Cognitive behavioral therapy for insomnia is recommended for treating insomnia in PTSD patients, but the best timing for this therapy in relation to PTSD treatment is still unclear, highlighting a gap in current clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD. Colvonen, PJ., Straus, LD., Stepnowsky, C., et al.[2023]

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 trial involving 14 combat veterans with insomnia showed that combined cognitive behavioral therapy for insomnia (CBT-I) and imagery rehearsal therapy (IRT) led to clinically significant improvements in sleep quality.

Participants experienced statistically significant reductions in insomnia, nightmares, depression, and posttraumatic stress severity, suggesting that this combined therapy is a promising treatment for veterans with combat-related trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia and Imagery Rehearsal in Combat Veterans with Comorbid Posttraumatic Stress: A Case Series. Bishop, TM., Britton, PC., Knox, KL., et al.[2020]

A study involving 40 combat veterans showed that combining cognitive-behavioral therapy for insomnia (CBT-I) with imagery rehearsal therapy (IRT) significantly improved both sleep quality and reduced PTSD symptoms compared to a waitlist control group.

Participants who received the combined therapy reported not only better sleep but also lower levels of depression and distress, indicating that this approach may be effective for treating insomnia and PTSD in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a cognitive-behavioral treatment for insomnia and nightmares in Afghanistan and Iraq veterans with PTSD. Margolies, SO., Rybarczyk, B., Vrana, SR., et al.[2022]

References

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

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

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

Treatment of comorbid sleep disorders and posttraumatic stress disorder in active duty military: Design and methodology of a randomized clinical trial. [2021]

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

Treatment of comorbid sleep disorders and posttraumatic stress disorder in U.S. active duty military personnel: A pilot randomized clinical trial. [2023]

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

Treatment of residual insomnia after CBT for PTSD: case studies. [2022]

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

Piloting cognitive-behavioral therapy for insomnia integrated with prolonged exposure. [2023]

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

A combined group treatment for nightmares and insomnia in combat veterans: a pilot study. [2022]

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

Recent Advancements in Treating Sleep Disorders in Co-Occurring PTSD. [2023]

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 and Imagery Rehearsal in Combat Veterans with Comorbid Posttraumatic Stress: A Case Series. [2020]

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

Efficacy of a cognitive-behavioral treatment for insomnia and nightmares in Afghanistan and Iraq veterans with PTSD. [2022]