Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI)

Browse trials for

• Sleep Initiation and Maintenance Disorders 2,722
• Stress Disorders, Post-Traumatic 2,682

Keywords

• Insomnia
• Service Members
• Cognitive Behavioral Therapy for Insomnia
• Digital Application

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's planned enrollment of 144 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Lead sponsor

Madigan Army Medical Center is the lead sponsor of 26 studies on the registry; 4 are open to participants now.

Study arms

• Experimental
  Digital App CBTI

  Participants will use a digital app for self-directed CBTI for five weeks.

  Behavioral: Cognitive Behavioral Therapy for Insomnia

• No intervention
  Waitlist Control

  This group will be placed on a waitlist control group until the follow up period is complete.

Interventions

• BehavioralCognitive Behavioral Therapy for Insomnia

  This intervention will be delivered via a smart phone app

Primary outcomes

1. Insomnia Severity

   Insomnia severity will be measured with the Insomnia Severity Index (ISI). The ISI is a seven-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms in the past 2 weeks. Items are rated on scales from 0 - 4 (none-severe). Item ratings are summed to get a total score, with higher scores reflecting greater insomnia severity (0-7 = no clinically significant insomnia, 8-14 = subthreshold insomnia, 15-21 = clinically significant insomnia -moderate, 22-28 = clinically significant insomnia - severe).

   Time frame: Baseline, Six Weeks, Nine Weeks

Secondary outcomes

1. Consensus Sleep Diary

   Subjective sleep measures will be captured using the Consensus Sleep Diary (CSD). The CSD is a nine-item tool which provides participant reported daily sleep patterns and sleep outcome measures. The CSD was developed by leading sleep experts in an effort to create a standardized sleep diary for clinicians and researchers. Sleep diaries have been regarded as a gold standard for subjective sleep assessment, and are viewed by sleep experts as a useful methodology for prospective self-monitoring of sleep for individuals with insomnia. Through simple questions delivered via the Insomnia Coach app, participants are asked to report daytime napping, bedtime, time attempted to fall asleep, sleep onset latency (SOL), number of awakenings (NOA), wake after sleep onset (WASO), total sleep time (TST), time of awakening, sleep efficiency (SE), and sleep quality using a 5-point scale from 1-5 (1 = "very poor," 2 = "poor," 3 = "fair," 4 = "good," 5 = "very good").

   Time frame: Baseline, Six Weeks

2. PROMIS Sleep-Related Impairment 8a

   The PROMIS Sleep-Related Impairment 8a (PROMIS-SRI 8a) is an 8-item self-report measure assesses daytime sleep-related impairment (SRI) over the past seven days. The PROMIS Sleep-Related Impairment 8a is the short form of the PROMIS-SRI 16. Each item has five response options ranging from 1- 5 (1 = "not at all," 2 = "a little bit," 3 = "somewhat," 4 = "quite a bit," 5 = "very much"). Higher scores indicating greater daytime function disturbances (range 0-40). Item ratings are summed to compute a raw score, which is converted to a standardized T score using conversion tables published on the Patient-Reported Outcomes Measurement Information System (PROMIS) website (nihpromis.org).

   Time frame: Baseline, Six Weeks, Nine Weeks

3. The Post Traumatic Stress Disorder Checklist-Military Version (PCL-M)

   The Post Traumatic Stress Disorder Checklist-Military Version (PCL-M) is a self-report questionnaire designed to assess the symptoms of PTSD in which 17 items correspond to the Diagnostic and Statistical Manual of Mental Disorders PTSD criteria. Items one through five correspond to re-experiencing symptoms, items five and six correspond to avoidance symptoms, items eight through twelve correspond to numbing symptoms, and items thirteen through seventeen correspond to hyperarousal symptoms. Individuals are asked to endorse the level of distress with each symptom over the last 30 days. Items are scored on a five-point Likert scale with 1 = "not at all" to 5 = "extremely." A total symptom severity score is obtained (range 17-85), with higher scores indicating higher PTSD symptoms and scores greater than 50 indicating a high likelihood of PTSD diagnosis.

   Time frame: Baseline, Six Weeks, Ten Weeks

4. The Patient Health Questionnaire-8 (PHQ-8)

   The Patient Health Questionnaire-8 (PHQ-8) is an eight item self-report questionnaire used to examine depression severity with similar psychometric properties of the PHQ-9. The PHQ-8 omits the final question of the PHQ-9 regarding suicide as the electronic delivery of the instruments may not provide timely clinical response to a positive endorsement of this question. Individuals are asked to endorse the level of distress with each symptom on the PHQ-9 in the last two weeks. A four-point Likert scale with 0 = "not at all," 1 = "several days," 2 = "more than half the days," and 3 = "nearly every day" is used. A total symptom severity score is obtained (range 0-24). Severity of depression is scored as follows: 0-4 no significant depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-24 severe depression. Scores greater than ten indicate a high likelihood of depression.

   Time frame: Baseline, Six Weeks, Nine Weeks

5. RAND-36 Item Short Form Survey

   The RAND-36 Item Short Form Survey (RAND-36) is a health-related quality of life questionnaire that assesses how health impacts on an individual's ability to function \& their perceived well-being in physical, mental and social domains of life. The RAND-36 includes a total of 36 items which includes eight domains representing aspects of health and quality of life: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Each domain includes either Likert type questions (with either 1-5 or 1-3 scales) and binary yes/no questions. The 36 items are grouped by the eight domains and each domain has a profile score (range 0-100). Higher scores within each domain indicate better health, higher quality of life, and less functional limitation.

   Time frame: Baseline, Six Weeks, Ten Weeks

Individual participant data

Plan to share: Undecided — Participant de-identified data sharing has not been determined at this point in time. Considerations include this data is DoD data and since the study has not started, it is unknown how much data or the quality of the data that will be obtained.