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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how insomnia (trouble sleeping) might increase the risk of heart disease in individuals with PTSD (post-traumatic stress disorder). It tests whether cognitive behavioral therapy (a type of talk therapy) for insomnia can reduce this risk. Participants will either engage in therapy sessions or receive minimal contact for monitoring. Individuals with PTSD for at least three months who also suffer from insomnia might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding the link between insomnia and heart disease in PTSD, potentially benefiting future treatments.

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.

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

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and can help people with PTSD who have trouble sleeping. Studies have found that CBT-I improves sleep quality and overall functioning in those dealing with insomnia and PTSD. Participants reported better sleep and found the therapy acceptable and helpful. While more research is always welcome, current evidence suggests that CBT-I is well-tolerated and usually does not cause serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavior Therapy for Insomnia (CBT-I) as a treatment for PTSD because it targets insomnia, a key symptom that can exacerbate PTSD. Unlike typical medications for PTSD, which often focus on reducing anxiety or depression, CBT-I is a non-drug therapy that aims to improve sleep patterns through behavioral changes and cognitive restructuring. This approach is unique because it empowers individuals to regain control over their sleep without relying on medication, potentially reducing side effects and dependency. By directly addressing sleep issues, CBT-I can enhance overall PTSD treatment outcomes, offering a holistic and sustainable approach to managing this challenging condition.

What evidence suggests that Cognitive Behavior Therapy for Insomnia is effective for PTSD?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, can improve sleep for people with PTSD. Studies have found that CBT-I increases the time spent asleep while in bed. It also reduces PTSD symptoms by addressing the fear of sleep, common among those with PTSD. CBT-I effectively treats insomnia in individuals with other mental health issues, such as depression and alcohol dependency. These findings suggest that CBT-I could be a promising method to enhance sleep and reduce health risks for people with PTSD. Meanwhile, participants in the minimal contact control condition will receive weekly phone contacts to monitor their insomnia symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Jean C Beckham, PhD

Principal Investigator

Duke Health

Andrew Sherwood, PhD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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 (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 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]

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 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]

Citations

1. 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 ...

2. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1649937.pdf

Cognitive Behavioral Therapy for Insomnia With Prolonged ... 43–45 CBT-I has been shown to be effective in treating insomnia in individuals with co-occurring PTSD, increasing sleep efficiency (SE) and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000107

Cognitive behavioral therapy for insomnia in patients with ... CBT-I is an effective treatment for patients with insomnia and a comorbid mental disorder, especially depression, PTSD and alcohol dependency.

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

Cognitive Behavioral Therapy for Insomnia Reduces Fear of ... Instead, follow-up analyses demonstrated that a reduction in fear of sleep following CBT-I was associated with a reduction in PTSD symptom ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40488726/

Cognitive Behavioral Therapy for Insomnia With Prolonged ... Conclusions: On average, participants had reductions in PTSD symptoms, with no differences between the groups. CBTI-PE produced greater ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3083990/

Cognitive behavioral therapy for the treatment of post ... Categorical diagnostic data indicated clinical recovery of 67% (post-treatment) and 76% at 3 months in the CBT group. 22, MVA, CBT, SP, One-year results showed ...

7. 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 ...