Cognitive Behavioral Therapy for PTSD

Overseen By Tiffany Mosher, MA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Benzodiazepines

Must not be taking: Psychoactive, Cardiovascular

Disqualifiers: CVD history, Substance use, Bipolar, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants have stable medications and doses for at least one month before and during the study. If your medications are not stable, you may need to adjust them before participating.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia for PTSD?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep, reduce nightmares, and enhance overall PTSD symptoms in individuals with PTSD. Studies have found that combining CBT-I with other PTSD treatments leads to better outcomes than treating PTSD alone. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for PTSD safe for humans?

Cognitive Behavioral Therapy (CBT) for PTSD, including its variations like CBT for insomnia and nightmares, has been studied in military personnel and veterans. These studies suggest that CBT is generally safe and can lead to improvements in PTSD symptoms, sleep quality, and nightmares without significant safety concerns. ^{1 4 6 7 8}

How does Cognitive Behavioral Therapy for Insomnia differ from other treatments for PTSD?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is unique because it specifically targets sleep disturbances like insomnia, which are common in PTSD patients, and can be used as a preparatory step before exposure therapy. This approach not only improves sleep but also helps patients better engage in trauma-specific therapies, potentially leading to greater overall improvements in PTSD symptoms. ^{1 4 5 8 9}

What is the purpose of this trial?

Posttraumatic stress disorder (PTSD) is a chronic, debilitating psychiatric disorder that is associated with an increased risk of death due to cardiovascular disease (CVD). Most individuals with PTSD also have Insomnia Disorder. Sleep quality is also associated with risk factors for CVD. The objective of this study is to examine how insomnia contributes to CVD risk among people with PTSD. The investigators will also examine whether this risk can be decreased with treatment for Insomnia Disorder.

Research Team

Jean C Beckham, PhD

Principal Investigator

Duke Health

Andrew Sherwood, PhD

Principal Investigator

Duke Health

Eligibility Criteria

This trial is for adults aged 40-59 with chronic PTSD and insomnia, without a history of cardiovascular events or severe mental health conditions like psychosis. Participants must not be pregnant, have restless leg syndrome, sleep apnea, or other major health issues that could interfere with the study.

Inclusion Criteria

I am between 40 and 59 years old.

I have been diagnosed with chronic PTSD for at least 3 months.

I am between 40 and 59 years old.

Exclusion Criteria

I experience seizures.

You work overnight.

Meets criteria for a psychotic spectrum disorder or bipolar disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioral therapy for insomnia (CBT-I) or are monitored in a minimal contact control condition for 8 weeks

8 weeks

8 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in sleep efficiency, blood pressure, and cardiovascular risk biomarkers

6 months

2 visits (in-person)

Treatment Details

Interventions

• Cognitive Behavior Therapy for Insomnia
• Weekly phone contacts

Trial Overview The study tests if Cognitive Behavior Therapy for Insomnia can reduce cardiovascular risk in PTSD patients. It involves weekly phone check-ins to monitor progress and adherence to the therapy.

Participant Groups

Group I: Minimal Contact Control Condition Experimental Treatment 1 Intervention

Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms.

Group II: Cognitive Behavior Therapy for Insomnia (CBT-I) Experimental Treatment 1 Intervention

Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

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]

Cognitive-behavioral therapy for insomnia (CBT-I) significantly improved sleep quality, mental health symptoms, and quality of life in a study of 73 women veterans, including those with probable PTSD.

Women veterans with probable PTSD experienced greater benefits from CBT-I, showing significant reductions in nightmares and improvements in sleep efficiency, with 66.7% reporting clinically significant reductions in PTSD symptoms after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Cognitive Behavioral Therapy for Insomnia for Women Veterans with and without Probable Post-Traumatic Stress Disorder. Carlson, GC., Kelly, MR., Mitchell, M., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep quality in adults with PTSD, with 41% of participants achieving full remission in sleep issues compared to none in the control group, and these improvements were maintained at a 6-month follow-up.

CBT-I also led to enhancements in overall psychosocial functioning and reductions in disruptive nocturnal behaviors, indicating that addressing sleep issues can have broader benefits for individuals suffering from PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. Talbot, LS., Maguen, S., Metzler, TJ., et al.[2022]

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]

Cognitive Behavioral Therapy for Insomnia (CBT-I) was effective for 47% of veterans with PTSD-related insomnia, with 77% completing the treatment, indicating a significant potential for improving sleep in this population.

The study found that prior use of hypnotics negatively impacted the response to CBT-I, suggesting that treatment strategies should consider medication history to enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of cognitive behavioral therapy outcomes for insomnia in veterans with post-traumatic stress disorder. El-Solh, AA., O'Brien, N., Akinnusi, M., et al.[2020]

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]

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]

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]

References

1. 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]

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

Benefits of Cognitive Behavioral Therapy for Insomnia for Women Veterans with and without Probable Post-Traumatic Stress Disorder. [2022]

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

Cognitive behavioral therapy for insomnia in posttraumatic stress disorder: a randomized controlled trial. [2022]

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Predictors of cognitive behavioral therapy outcomes for insomnia in veterans with post-traumatic stress disorder. [2020]

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

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

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]