Anxiety & Depression Association of America

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

Purpose

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.

Conditions

Insomnia
PTSD - Post Traumatic Stress Disorder
Nightmares

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Written exposure therapy and sleep hygiene for insomnia and nightmares		Behavioral: Written Exposure Therapy (WET) WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist. Behavioral: Sleep Hygiene Involves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices.
Experimental Written exposure therapy and CBT for insomnia and nightmares		Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTi) CBTi focuses on stimulus control, eliminating maladaptive coping habits, reducing arousal, and challenging maladaptive thoughts about sleep in an effort to reduce time to fall asleep and time awake during the night. Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn) CBTn involves writing about a distressing or frequent nightmare, rewriting the narrative of the nightmare to target trauma-related themes, and reading the rescripted nightmare narrative. Behavioral: Written Exposure Therapy (WET) WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Palo Alto Veterans Institute for Research

Study Contact

Carmen McLean, PhD
650-614-9997
carmen.mclean4@va.gov

Detailed 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.