Health Trials

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

ConditionsInsomniaPTSD - Post Traumatic Stress DisorderNightmares
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPalo Alto Veterans Institute for Research

About this trial

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.

Eligibility criteria

Qualifiers

Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.

Ability to speak and read English.

Clinically significant PTSD symptoms (CAPS-5 > 25 with at least one Intrusion symptom and at least one Avoidance symptom).

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).

Disqualifiers

Current suicide or homicide risk meriting crisis intervention.

Inability to comprehend the baseline screening questionnaires.

Unwilling to remain abstinent from alcohol during therapy sessions.

Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.

Trial design

Treatments tested in this trial

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

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Fort HoodRecruiting76544, Kileen, TexasUnited StatesUnited States

Sponsors and collaborators

Palo Alto Veterans Institute for Research

Lead sponsor

The University of Texas Health Science Center at San Antonio

Collaborator

University of Arizona

Collaborator

NDRI-USA, Inc.

Collaborator

Source ClinicalTrials.gov