Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

Comparing Insomnia Care As Usual to Digital Augmentation

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: COAST-enhanced CBTI; Behavioral: Military Treatment Facility Insomnia Care As Usual

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Germain, PhD; Phone Number: (412) 897-3183; Email: anne@noctemhealth.com
• Study Contact Backup: Name: Megan Wolfson, LCSW; Phone Number: (412) 360-4878; Email: megan@noctemhealth.com

Study Locations

• United States
  • Washington
    • Lakewood, Washington, United States, 98431
      • Recruiting
      • Madigan Army Medical Center
      • Contact: Brian O'Reilly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Active duty service members, men and women, diagnosed with chronic insomnia and deemed eligible for CBTI by their treating clinician.
• Age 18 or older.
• Absence of, or stable, psychiatric, or medical comorbidity(ies), such that they do not compromise safety when completing study procedures.
• If using prescribed sleep medication(s), have received the medication(s) at a stable dosage for at least 4 weeks, with no scheduled change in medication or dosage over the acute intervention phase (up to 12 weeks)
• Owning or ability to use a smartphone (iPhone or Android) that is no older than 5 years old (e.g., iPhone 6, and Android phone with Lollipop 5.0 mobile operating system)

Exclusion Criteria:

• Presence of an untreated or under-treated comorbid sleep disorder that requires independent treatment or that may be exacerbated by sleep restriction or stimuli control, e.g., obstructive sleep apnea (OSA) or rapid-eye-movement (REM) behavior disorder or sleep walking with a history of injury to self or others.
• Acute psychiatric distress associated with marked impairments in functioning or that limits engagement in CBTI, adversely impacts the risk/benefit ratio of participating in the study, or requires immediate attention, as indicated by, but not limited to, the examples listed below. Please note that each referring clinician will determine whether a patient is eligible for the study.
• Having planned or attempted suicide or the harming of others in the past 6 months.
• Seeking and/or receiving treatment at psychiatric clinic facility at a level that requires inpatient or partial hospitalization level of psychiatric care.
• Currently requiring the support of an assigned case manager for services such as coordination of medications, appointments, transportation, and/or for completing activities of daily living.
• Active substance use disorder.
• Past or current psychotic or bipolar disorder or sub-threshold symptoms of psychotic or bipolar disorders.
• Currently pregnant, breastfeeding, or being the parent of a newborn < 3 months old.
• Untreated seizure disorder.
• Suspected, diagnosed, or inadequately treated sleep apnea (less than 4 hours of CPAP use per night).
• Anticipates relocating/moving out of state in the next 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: COAST-enhanced CBTI; 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.	Behavioral: COAST-enhanced CBTI; 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.
Active Comparator: Military Treatment Facility Insomnia Care As Usual; 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.	Behavioral: Military Treatment Facility Insomnia Care As Usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Noctem, LLC
• Investigators: Principal Investigator: Anne Germain, Noctem, LLC

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Insomnia; Digital Technology; Cognitive Behavioral Therapy for Insomnia (CBTI); Adherence Monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: JW210372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No