Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD

Palo Alto Veterans Institute for Research

Status: Enrolling

Conditions: PTSD - Post Traumatic Stress Disorder; Nightmares; Insomnia

Treatments: Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTi); Behavioral: Written Exposure Therapy (WET); Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn); Behavioral: Sleep Hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT07069517

MCA0010

Details and patient eligibility

About

This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.

Full description

The aims of the study are:

1. Determine the efficacy of accelerated cognitive behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET) for PTSD for improving insomnia symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.
2. Determine the efficacy of accelerated CBTi+n integrated with WET for improving nightmare symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.

Exploratory Aim: Determine the efficacy of accelerated CBTi+n integrated with WET for improving PTSD symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.
2. Ability to speak and read English.
3. Clinically significant PTSD symptoms (CAPS-5 > 25 with at least one Intrusion symptom and at least one Avoidance symptom).
4. Clinically significant symptoms of insomnia disorder (Structured Clinical Interview for Sleep Disturbance DSM-5 (SCISD) Insomnia Criteria are met and Insomnia Severity Index (ISI) > 11).
5. Nightmares > 1 monthly (as reported on the SCISD).
6. Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation.

Exclusion criteria

1. Current suicide or homicide risk meriting crisis intervention.
2. Inability to comprehend the baseline screening questionnaires.
3. Unwilling to remain abstinent from alcohol during therapy sessions.
4. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.
5. Currently engaged in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy) or insomnia or nightmares (e.g., Cognitive Behavioral Therapy for Insomnia or Nightmares).
6. Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares.
7. Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Written exposure therapy and sleep hygiene for insomnia and nightmares

Active Comparator group

Treatment:

Behavioral: Sleep Hygiene

Behavioral: Written Exposure Therapy (WET)

Written exposure therapy and CBT for insomnia and nightmares

Experimental group

Treatment:

Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn)

Behavioral: Written Exposure Therapy (WET)

Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTi)