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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist women Veterans with sleep issues stemming from PTSD, a condition following a deeply distressing event. It compares two approaches: Trauma-Informed CBT-I, which adapts common insomnia therapy to address trauma, and PTSD Psychoeducation, which provides education on PTSD symptoms. The trial aims to determine which approach better prepares participants to begin and continue PTSD treatment. Women Veterans with sleep difficulties and PTSD symptoms may be suitable for this trial. Participants will be randomly assigned to one of the two treatments and will have follow-ups to assess their progress. As an unphased trial, this study offers participants a unique chance to contribute to innovative research that could enhance PTSD treatment strategies for women Veterans.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and well-tolerated. In one study, women who completed this therapy reported better sleep and found the treatment acceptable. Another study found that CBT-I improved overall functioning in people with PTSD. However, some PTSD symptoms might not improve as much with this therapy alone.

These findings suggest that trauma-informed CBT-I is safe for those with insomnia and PTSD. However, consulting a healthcare provider before starting any new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Trauma-Informed CBT-I for PTSD-related insomnia because it offers a tailored approach by incorporating trauma-informed care into Cognitive Behavioral Therapy for Insomnia (CBT-I). Unlike standard CBT-I, which primarily targets insomnia symptoms, this treatment is specifically adapted to address the unique challenges faced by individuals with PTSD. By focusing on the interplay between trauma and sleep disturbances, it aims to provide a more comprehensive solution that not only improves sleep but also acknowledges and integrates the trauma-related aspects affecting the patient’s overall well-being.

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

Research has shown that trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, can greatly improve sleep for people with posttraumatic stress disorder (PTSD). Women who completed this therapy slept better for up to three months after finishing treatment and found it very helpful. Another study found that CBT-I led to lasting sleep improvements for people with PTSD, with benefits still noticeable six months later. This therapy also reduces fear related to sleep in PTSD patients. Overall, these findings suggest that trauma-informed CBT-I effectively helps people with PTSD who have trouble sleeping. ^{1 2 3 6 7}

Who Is on the Research Team?

Gwendolyn C Carlson, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722925000264

Trauma-Informed Cognitive Behavioral Therapy for ... Women who completed trauma-informed CBT-I reported improved sleep outcomes from baseline to 3-month follow-up and high perceived acceptability ...

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

Cognitive Behavioral Therapy for Insomnia in Posttraumatic ... Cognitive behavioral therapy for insomnia (CBT-I) improved sleep in individuals with posttraumatic stress disorder, with durable gains at 6 mo. Overall ...

3. 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 ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820897

Internet-Guided Cognitive Behavioral Therapy for Insomnia ... These findings suggest that when successfully completed, eCBT-I can provide clinical benefits in military service members and veterans with TBI and insomnia.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7224

Cognitive Behavioral Therapy for Insomnia Reduces Fear of ... This is the first study to examine fear of sleep in individuals with PTSD and insomnia using standard objective and subjective measures and a therapeutic ...

6. academic.oup.com academic.oup.com/sleep/article/45/Supplement_1/A208/6592804

0471 Identifying Trauma-Informed Adaptations to Cognitive ... Trauma-informed adaptations, including supplemental materials, may improve CBT-I outcomes for patients with comorbid PTSD. Future studies should ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8760360/

A Randomized Clinical Trial of Cognitive-Behavioral ... Cognitive behavioral therapy for insomnia (CBTi) improves insomnia in individuals with PTSD, but PTSD severity remains elevated.