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

Browse trials for

• Sleep Initiation and Maintenance Disorders 1,836
• Combat Disorders 132

Study arms

• Active comparator
  Written exposure therapy and sleep hygiene for insomnia and nightmares

  Behavioral: Written Exposure Therapy (WET) · Behavioral: Sleep Hygiene

• Experimental
  Written exposure therapy and CBT for insomnia and nightmares

  Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTi) · Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn) · Behavioral: Written Exposure Therapy (WET)

Interventions

• BehavioralCognitive-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.

• BehavioralCognitive 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.

• BehavioralWritten Exposure Therapy (WET)

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

• BehavioralSleep Hygiene

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

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

5. Depressive Symptoms Index-Suicidality Subscale (DSI-SS)

   The DSI-SS is a self-report measure of suicidal ideation, plans, perceived control over ideation, and impulses for suicide. Total scores range from 0-12 (higher scores indicate greater suicidality).

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

6. Patient Health Questionnaire-9 (PHQ-9)

   The PHQ-9 assess the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder. Total scores range from 0-27 (higher scores indicate greater depressive symptom severity).

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

7. Brief Inventory of Psychosocial Functioning (B-IPF)

   B-IPF is a 7-item measure of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. Total scores range from 0-42 (higher scores indicate greater functional impairment).

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

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

5. Health Questionnaire

   Health Questionnaire measures medical and mental health diagnoses that respondents have received, medical board and disability status, medications taken, and caffeine use

   Time frame: Measured at baseline

6. Fitbit Inspire HR data will be downloaded through the Fitabase platform

   Fitbit Inspire HR will measure heart rate, physical activity, and nighttime wakefulness.

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

7. Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

   Q-SF is a 16-item measure of life satisfaction and enjoyment in different areas of life over the past week. Total scores range from 14-70 (higher scores indicate greater enjoyment and satisfaction with life).

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

8. Credibility and Expectancy Questionnaire (CEQ)

   The CEQ is a 6-item measure that was designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies

   Time frame: Change from pre-workshop through 1 month follow up

Individual participant data

Plan to share: Yes — The data used to conduct these analyses are stored in the STRONG STAR Repository. Deidentified data can be accessed by emailing repository@strongstar.org