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

Official title

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

Overview

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.

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.

Primary outcome measures

• Posttraumatic Stress Disorder Checklist (PCL-5) [Time frame: Change from baseline through 3 and 6 month follow-up assessment]
• Insomnia Severity Index (ISI) [Time frame: Change from baseline through 3 and 6 month follow up]
• Nightmare Disorders Index [Time frame: Change from baseline through 3 and 6 month assessments]

Secondary outcome measures (7)

• Clinician Administered PTSD Scale (CAPS-5) [Time frame: Change from baseline to 1-month follow-up assessment]
• Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R) [Time frame: Change from baseline to 1-month follow-up assessment]
• Generalized Anxiety Disorder Screener (GAD-7) [Time frame: Change from baseline through 3 and 6 month follow-up assessment]
• Trauma-Related Nightmare Survey (TRNS) [Time frame: Change from baseline through 3 and 6 month follow-up assessment]
• Depressive Symptoms Index-Suicidality Subscale (DSI-SS) [Time frame: Change from baseline through 3 and 6 month follow up assessment]
• Patient Health Questionnaire-9 (PHQ-9) [Time frame: Change from baseline through 3 and 6 follow-up assessment]
• Brief Inventory of Psychosocial Functioning (B-IPF) [Time frame: Change from baseline through 3 and 6 month follow up]

Eligibility criteria

Inclusion criteria

• 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).
• Nightmares > 1 monthly (as reported on the SCISD).
• 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.
• 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.
• 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).
• Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares.
• Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Fort Hood — Kileen

Identifiers

NCT: NCT07069517 · MCA0010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗