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

NCT07069517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

  • Insomnia
  • PTSD - Post Traumatic Stress Disorder
  • Nightmares

Interventions

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER
  • University of Arizona

    collaborator OTHER
  • NDRI-USA, Inc.

    collaborator OTHER
  • Palo Alto Veterans Institute for Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2028-12-01
Completion
2028-12-01

Countries

  • United States

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07069517 on ClinicalTrials.gov