NCT07069517

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

Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Palo Alto Veterans Institute for Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Insomnia
• PTSD - Post Traumatic Stress Disorder
• Nightmares

Interventions

Type	Name	Description
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.
BEHAVIORAL	Sleep Hygiene	Involves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices.

Timeline

• Start date: 2025-12-02
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-07-16
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States