Insomnia, Nightmares, PTSD - Post Traumatic Stress Disorder
Conditions
Brief 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.
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
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.
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.
Sponsors
The University of Texas Health Science Center at San Antonio
University of Arizona
NDRI-USA, Inc.
Palo Alto Veterans Institute for Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old. 2. Ability to speak and read English. 3. Clinically significant PTSD symptoms (CAPS-5 \> 25 with at least one Intrusion symptom and at least one Avoidance symptom). 4. 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). 5. Nightmares \> 1 monthly (as reported on the SCISD). 6. Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation.
Exclusion criteria
1. Current suicide or homicide risk meriting crisis intervention. 2. Inability to comprehend the baseline screening questionnaires. 3. Unwilling to remain abstinent from alcohol during therapy sessions. 4. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement. 5. 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). 6. Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares. 7. Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder Checklist (PCL-5) | Change from baseline through 3 and 6 month follow-up assessment | 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). |
| Nightmare Disorders Index | Change from baseline through 3 and 6 month assessments | The NDI is a self-report assessment of nightmare disorder. |
| Insomnia Severity Index (ISI) | Change from baseline through 3 and 6 month follow up | The ISI assesses perceived severity of insomnia. Total scores range from 0-28 (higher scores indicate greater insomnia severity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R) | Change from baseline to 1-month follow-up assessment | 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. |
| Clinician Administered PTSD Scale (CAPS-5) | Change from baseline to 1-month follow-up assessment | 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). |
| Generalized Anxiety Disorder Screener (GAD-7) | Change from baseline through 3 and 6 month follow-up assessment | GAD-7 is a 7-item measure that assesses generalized anxiety symptomology. Total scores range from 0-21 (higher scores indicate greater anxiety). |
| Trauma-Related Nightmare Survey (TRNS) | Change from baseline through 3 and 6 month follow-up assessment | The TRNS assesses nightmare frequency, disturbance, and characteristics |
| Depressive Symptoms Index-Suicidality Subscale (DSI-SS) | Change from baseline through 3 and 6 month follow up assessment | 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). |
| Patient Health Questionnaire-9 (PHQ-9) | Change from baseline through 3 and 6 follow-up assessment | 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). |
| Brief Inventory of Psychosocial Functioning (B-IPF) | Change from baseline through 3 and 6 month follow up | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep Diary and Nightmare Log | Change from second baseline through to the end of treatment | The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations. |
| Split Week Self-Assessment of Sleep Survey (SASS-Y) | Change from baseline through 3 and 6 month follow up assessments | 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. |
| Health Questionnaire | Measured at baseline | Health Questionnaire measures medical and mental health diagnoses that respondents have received, medical board and disability status, medications taken, and caffeine use |
| Fitbit Inspire HR data will be downloaded through the Fitabase platform | Change from second baseline through 3 and 6 month follow-up | Fitbit Inspire HR will measure heart rate, physical activity, and nighttime wakefulness. |
| Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | Change from baseline through 3 and 6 month follow up assessments | 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). |
| Credibility and Expectancy Questionnaire (CEQ) | Change from pre-workshop through 1 month follow up | The CEQ is a 6-item measure that was designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies |
| History of Head Injuries | Measured during baseline | History of Head Injuries is a 3 question screener that assesses for head injury and altered consciousness. |
| Neuropsychological battery | Change from second baseline to 1-month follow-up assessment | 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. |
Countries
United States
Contacts
Primary ContactCarmen McLean, PhD
Outcome results
None listed