Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Cognitive-Behavioral Therapy for Insomnia (CBTi)

    Behavioral

    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.

  • Cognitive Behavioral Therapy for Nightmares (CBTn)

    Behavioral

    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.

  • Written Exposure Therapy (WET)

    Behavioral

    WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.

  • Sleep Hygiene

    Behavioral

    Involves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Written exposure therapy and sleep hygiene for insomnia and nightmaresActive comparator 2 interventions
Group B: Written exposure therapy and CBT for insomnia and nightmaresExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Posttraumatic Stress Disorder Checklist (PCL-5)

Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. Total scores range from 0-80 (higher scores indicate greater PTSD severity).

Time frame
Change from baseline through 3 and 6 month follow-up assessment
2

Insomnia Severity Index (ISI)

The ISI assesses perceived severity of insomnia. Total scores range from 0-28 (higher scores indicate greater insomnia severity).

Time frame
Change from baseline through 3 and 6 month follow up
3

Nightmare Disorders Index

The NDI is a self-report assessment of nightmare disorder.

Time frame
Change from baseline through 3 and 6 month assessments

Secondary outcomes

1

Clinician Administered PTSD Scale (CAPS-5)

The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Total scores range from 0-80 (higher scores indicate greater PTSD severity).

Time frame
Change from baseline to 1-month follow-up assessment
2

Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)

The SCISD-R is a semi-structured interview designed to obtain a sleep history and screen for certain sleep disorders and diagnose others, including insomnia, hypersomnia, circadian rhythm sleep-wake disorders, sleep-disordered breathing, and parasomnias.

Time frame
Change from baseline to 1-month follow-up assessment
3

Generalized Anxiety Disorder Screener (GAD-7)

GAD-7 is a 7-item measure that assesses generalized anxiety symptomology. Total scores range from 0-21 (higher scores indicate greater anxiety).

Time frame
Change from baseline through 3 and 6 month follow-up assessment
4

Trauma-Related Nightmare Survey (TRNS)

The TRNS assesses nightmare frequency, disturbance, and characteristics

Time frame
Change from baseline through 3 and 6 month follow-up assessment

Other outcomes

1

Neuropsychological battery

The Neuropsychological battery draws from the from NIH toolbox Cognitive Battery and is comprised of the following tasks: Picture Vocab, Face Name Associative Memory Exam Test, Flanker Task, Oral Symbol Digit, Picture Sequence, Pattern Comparison, Dimensional Change, and Face Name Associative Memory Exam Delay.

Time frame
Change from second baseline to 1-month follow-up assessment
2

Split Week Self-Assessment of Sleep Survey (SASS-Y)

The SASS-Y measures average bedtime, sleep time, sleep onset latency, number of awakenings, wake time after sleep onset, wake time, out of bedtime and sleep quality.

Time frame
Change from baseline through 3 and 6 month follow up assessments
3

Sleep Diary and Nightmare Log

The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations.

Time frame
Change from second baseline through to the end of treatment
4

History of Head Injuries

History of Head Injuries is a 3 question screener that assesses for head injury and altered consciousness.

Time frame
Measured during baseline

Locations

1

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

Fort HoodRecruiting76544, Kileen, TexasUnited StatesUnited States

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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