160 Participants Needed

Cognitive-Behavioral Therapy for PTSD, Insomnia, and Nightmares

CM
Overseen ByCarmen McLean, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Palo Alto Veterans Institute for Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help individuals with PTSD (post-traumatic stress disorder), insomnia, and nightmares. Researchers will compare two treatments: one combines cognitive-behavioral therapy (CBT) for insomnia and nightmares with written exposure therapy (WET) for PTSD, while the other uses sleep hygiene tips (healthy sleep habits) instead of therapy for insomnia and nightmares. Active-duty military personnel or veterans experiencing significant PTSD symptoms, frequent insomnia, and nightmares, and willing to pause new treatments during the study, might find this trial beneficial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations for those seeking relief from these challenging symptoms.

Will I have to stop taking my current medications?

The trial requires participants to refrain from starting any new behavioral health or medication treatments for PTSD, sleep, and nightmares during the study. However, it does not specify if you need to stop your current medications.

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

Research shows that Cognitive-Behavioral Therapy for Insomnia (CBTi) is safe and effective for people with PTSD and sleep difficulties. Studies have found that it improves sleep quality, with benefits lasting at least six months. Importantly, these studies reported no serious side effects.

Cognitive Behavioral Therapy for Nightmares (CBTn) is also considered safe. A small study with military personnel found the treatment easy to complete and well-received by participants, with no major negative effects.

Written Exposure Therapy (WET) is another treatment in this study and is safe for people with PTSD. Research indicates it is effective, even for those with mood disorders. WET is brief and typically causes fewer side effects than other treatments.

Overall, these therapies are well-tolerated and have a good safety record based on past research. Participants in this study can expect them to be safe options for addressing insomnia, nightmares, and PTSD.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for PTSD, insomnia, and nightmares because they combine cognitive-behavioral therapies in a novel way. Cognitive-Behavioral Therapy for Insomnia (CBTi) and Cognitive Behavioral Therapy for Nightmares (CBTn) are specifically designed to address sleep-related issues, which are common but often neglected in PTSD treatment. Additionally, Written Exposure Therapy (WET) is a brief and efficient approach that may offer faster relief compared to traditional, lengthy talk therapies like prolonged exposure therapy. By integrating these therapies, the hope is to create a comprehensive treatment that tackles both the psychological and physiological aspects of PTSD, potentially leading to more effective and quicker outcomes.

What evidence suggests that this trial's treatments could be effective for PTSD, insomnia, and nightmares?

This trial will evaluate different therapy combinations for PTSD, insomnia, and nightmares. Research has shown that Cognitive-Behavioral Therapy for Insomnia (CBTi), which participants in this trial may receive, helps people with PTSD sleep better, with improvements lasting at least six months. Those who try CBTi often experience better sleep quality and feel less afraid of sleeping, which also eases PTSD symptoms. Evidence for Cognitive-Behavioral Therapy for Nightmares (CBTn), another therapy option in this trial, is encouraging, as it can reduce nightmares and improve overall well-being according to some studies. Written Exposure Therapy (WET), also being tested in this trial, effectively lessens PTSD symptoms, and research suggests it works well even for those with mood or substance use challenges. Together, these therapies show strong promise for treating PTSD, insomnia, and nightmares.12346

Are You a Good Fit for This Trial?

This trial is for active-duty military or veterans aged 18-65 with PTSD, experiencing frequent nightmares and significant insomnia. Participants must speak English, not start new treatments for these conditions during the study, and have a PTSD symptom score above a certain threshold.

Inclusion Criteria

I can speak and read English.
I have been diagnosed with severe insomnia.
I agree not to start new treatments for PTSD, sleep, or nightmares while in the study.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive accelerated cognitive-behavioral therapy for insomnia and nightmares integrated with Written Exposure Therapy for PTSD over a 5-day group treatment format, preceded and followed by individual treatment sessions

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive-Behavioral Therapy for Insomnia (CBTi)
  • Cognitive Behavioral Therapy for Nightmares (CBTn)
  • Written Exposure Therapy (WET)

Trial Overview

The trial compares two behavioral therapies: cognitive-behavioral therapy (CBT) for both insomnia and nightmares versus sleep hygiene education. Both are combined with Written Exposure Therapy for PTSD in an accelerated group format over five days plus individual sessions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Written exposure therapy and CBT for insomnia and nightmaresExperimental Treatment3 Interventions
Group II: Written exposure therapy and sleep hygiene for insomnia and nightmaresActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Palo Alto Veterans Institute for Research

Lead Sponsor

Trials
58
Recruited
8,800+

University of Arizona

Collaborator

Trials
545
Recruited
161,000+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials
486
Recruited
92,500+

NDRI-USA, Inc.

Collaborator

Trials
3
Recruited
1,400+

Citations

Cognitive behavioral therapy for the treatment of post ...

Exposure therapy and CBT led to a 48% and 53% reduction on PTSD symptoms, respectively, with no difference between them on any measure; results were maintained ...

Cognitive Behavioral Therapy for Insomnia in Posttraumatic ...

Overall psychosocial functioning improved following CBT-I. The initial evidence regarding CBT-I and nightmares is promising but further research is needed.

Cognitive Behavioral Treatments for Post-traumatic Stress ...

The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep ...

Digital Cognitive Behavioral Therapy–Based Treatment for ...

Objective: This pilot trial evaluated the feasibility of a 4-week, digital self-paced intervention combining cognitive behavioral therapy for ...

Treatment Development Report of an Intensive Group ...

Open pilot evaluation suggests that participants experienced reductions in PTSD symptoms, insomnia, and nightmares, and were satisfied with the ...

A pilot randomized controlled trial of cognitive behavioral ...

This pilot study demonstrates that a cognitive behavioral treatment for nightmares in an active duty military sample is acceptable and feasible.