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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMadigan Army Medical Center

About this trial

The goal of this pilot clinical trial is to evaluate the effectiveness and delivery method of a CBTI self-managed digital mobile application in service members.

The main questions it aims to answer are:

RQ1. Will the delivery of CBTI via a self-managed mobile application over five weeks improve sleep outcomes for service members?

RQ2. Will the delivery of CBTI via a self-managed mobile application over five weeks improve secondary outcomes (sleep-related impairment, depression, PTSD symptoms, and quality of life) for service members?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Active Duty, Reservist, Army National Guard

Ages 18-55 years

Own a smart phone

Internet access

Disqualifiers

Insomnia Severity Score > or equal to 10

PHQ-8 score <20

Untreated sleep disorders (sleep apnea, narcolepsy, parasomnias)

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive Behavioral Therapy for Insomnia

    Behavioral

    This intervention will be delivered via a smart phone app

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Digital App CBTIExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Madigan Army Medical Center

Lead sponsor

TriService Nursing Research Program (Funder)

Collaborator

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