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The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of insomnia, symptoms of depression and anxiety, and treatment satisfaction.
Chronic insomnia is pervasive among service members and adversely affects health and readiness. Insomnia rarely remits spontaneously, and sleep-focused treatments are required to reduce or eliminate insomnia. Cognitive Behavioral Treatment of Insomnia (CBTI) is the first line treatment for insomnia. CBTI remains underutilized and is often unavailable in care settings where service members receive sleep healthcare. Digital health technology is one of the strategic components identified by the DHA to support behavioral health, including sleep health. NOCTEM® has developed and validated its Clinician Operated Assistive Sleep Technology (COAST™) platform to scale delivery and access to CBTI. This non-inferiority trial will evaluate and compare the changes in insomnia severity following COAST-enhanced CBTI or insomnia care as usual (ICAU) pre- to post-treatment and at the 3-month follow up. Secondary outcomes of interest include changes in depression and anxiety over time, and patient satisfaction with insomnia care following COAST-enhanced CBTI or ICAU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COAST-enhanced CBTI | Active Comparator | Patients randomized to COAST will receive CBTI via the COAST platform, with the assistance of a licensed clinician via NOCTEM's digital sleep hub. Participants will utilize the COAST patient app on their smartphone for engagement in insomnia treatment and receipt of clinician's recommendations. COAST clinicians will utilize the COAST web-based portal for adherence monitoring, progress review, and for providing personalized insomnia treatment recommendations. |
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| Military Treatment Facility Insomnia Care As Usual | Active Comparator | Patients randomized to the ICAU arm will receive insomnia care as usual by a certified clinician at their respective site, according to current referral and treatment practices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COAST-enhanced CBTI | Behavioral | Participants will receive CBTI delivered through the COAST platform by one of NOCTEM's certified and licensed COAST clinician. Communication between the participant and licensed clinician will occur primarily through COAST's HIPAA-compliant text messaging, but clinicians and patients may elect to connect via telephone calls or HIPAA-compliant secure videoconference if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity | Insomnia Severity Index (ISI) | baseline |
| Insomnia Severity | Insomnia Severity Index (ISI) | 6-8 week check-in |
| Insomnia Severity | Insomnia Severity Index (ISI) | 3-month follow up |
| Symptoms of Depression | Patient Health Questionnaire-2 (PHQ-2) | baseline |
| Symptoms of Depression | Patient Health Questionnaire-2 (PHQ-2) | 6-8 week check-in |
| Symptoms of Depression | Patient Health Questionnaire-2 (PHQ-2) | 3-month follow up |
| Symptoms of Anxiety | Generalized Anxiety Disorder 2-item (GAD-2) | baseline |
| Symptoms of Anxiety | Generalized Anxiety Disorder 2-item (GAD-2) | 6-8 week check-in |
| Symptoms of Anxiety | Generalized Anxiety Disorder 2-item (GAD-2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Germain, PhD | Contact | (412) 897-3183 | anne@noctemhealth.com | |
| Megan Wolfson, LCSW | Contact | (412) 360-4878 | megan@noctemhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Anne Germain | Noctem, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center | Recruiting | Lakewood | Washington | 98431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33164742 | Background | Edinger JD, Arnedt JT, Bertisch SM, Carney CE, Harrington JJ, Lichstein KL, Sateia MJ, Troxel WM, Zhou ES, Kazmi U, Heald JL, Martin JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb 1;17(2):255-262. doi: 10.5664/jcsm.8986. | |
| 30530452 |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Participants will be randomized to one of two study arms (COAST-enhanced CBTI or insomnia care as usual) at the site level.
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| Military Treatment Facility Insomnia Care As Usual | Behavioral | Participants will receive the insomnia care offered at their site following current delivery practices (i.e., face-to-face or virtual; individual or group format). During the treatment phase, participants randomized to ICAU will be instructed to communicate with their clinicians as needed, according to standard procedures in place. |
|
| 3-month follow up |
| Acceptability of Insomnia Care | An adapted version of the Insomnia Treatment Acceptability Scale (ITAS) with ratings of perceived acceptability and treatment preference for both COAST-enhanced CBTI and insomnia care as usual (ICAU). | 6-8 week check-in |
| Satisfaction with Insomnia Care | Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment. | 6-8 week check in |
| Pulantara IW, Parmanto B, Germain A. Clinical Feasibility of a Just-in-Time Adaptive Intervention App (iREST) as a Behavioral Sleep Treatment in a Military Population: Feasibility Comparative Effectiveness Study. J Med Internet Res. 2018 Dec 7;20(12):e10124. doi: 10.2196/10124. |
| 37803393 | Derived | Germain A, Wolfson M, Brock MS, O'Reilly B, Hearn H, Knowles S, Mysliwiec V, Wallace ML. Digital CBTI hubs as a treatment augmentation strategy in military clinics: study protocol for a pragmatic randomized clinical trial. Trials. 2023 Oct 6;24(1):648. doi: 10.1186/s13063-023-07686-2. |
| D001523 |
| Mental Disorders |