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Not yet recruiting NCT07335276

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

No phase Interventional Insomnia Depression - Major Depressive Disorder PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Therapy for Insomnia.
Who it may be relevant to
Registry conditions: Insomnia, Depression - Major Depressive Disorder, PTSD. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI): A Pilot Randomized Controlled Trial for Service Members

Overview

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?

Detailed description

Participants enrolled in this trial will:

* Week 1: Complete a series of questionnaires (approximately 15 minutes) \& complete a daily sleep diary for one week (three minutes each morning). * Weeks 2-6: Participate in one of two groups that are randomly assigned: * Group 1: Starts use of the smart phone app with treatment for insomnia for five weeks. Each day during weeks 2-6 you will complete a daily sleep diary on the app and review individual sleep treatment recommendations (total of 5 minutes each morning).

OR

* Group 2: Will wait for five weeks * End of Week 6: Both Group 1 \& Group 2 will complete a series of questionnaires (approximately 15 minutes), \& complete a daily sleep diary for one week (three minutes each morning). * Week 10: Both Group 1 \& Group 2 will complete a series of questionnaires (approximately 15 minutes) about insomnia symptoms, any sleep related impaired function, depression symptoms, post-traumatic stress disorder symptoms, and quality of life. Participants randomized to the wait list will be contacted to provide information and support on how to use the smart phone app for treatment with insomnia.

Interventions

  • Behavioral Cognitive Behavioral Therapy for Insomnia
    This intervention will be delivered via a smart phone app

Primary outcome measures

  • Insomnia Severity [Time frame: Baseline, Six Weeks, Nine Weeks]
Secondary outcome measures (5)
  • Consensus Sleep Diary [Time frame: Baseline, Six Weeks]
  • PROMIS Sleep-Related Impairment 8a [Time frame: Baseline, Six Weeks, Nine Weeks]
  • The Post Traumatic Stress Disorder Checklist-Military Version (PCL-M) [Time frame: Baseline, Six Weeks, Ten Weeks]
  • The Patient Health Questionnaire-8 (PHQ-8) [Time frame: Baseline, Six Weeks, Nine Weeks]
  • RAND-36 Item Short Form Survey [Time frame: Baseline, Six Weeks, Ten Weeks]

Eligibility criteria

Inclusion criteria

  • Active Duty, Reservist, Army National Guard
  • Ages 18-55 years
  • Own a smart phone
  • Internet access

Exclusion criteria

  • Insomnia Severity Score > or equal to 10
  • PHQ-8 score <20
  • Untreated sleep disorders (sleep apnea, narcolepsy, parasomnias)
  • Pregnancy
  • Working rotating Shifts
  • Caring for a newborn <3 months old
  • Currently receiving cognitive behavioral therapy for insomnia
  • Received cognitive behavioral therapy for insomnia in the last 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07335276 · 11207-N25-D03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗