Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

NCT05490550 | Recruiting

• 1 other identifier: JW210372
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Insomnia

Keywords

Insomnia; Cognitive Behavioral Therapy for Insomnia (CBTI); Digital Technology; Adherence Monitoring

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

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.

Behavioral: COAST-enhanced CBTI

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.

Behavioral: Military Treatment Facility Insomnia Care As Usual

Interventions

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.

COAST-enhanced CBTI

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.

Military Treatment Facility Insomnia Care As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Noctem, LLC: lead

Study Sites (1)

Madigan Army Medical Center

Lakewood, Washington, 98431, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 33164742 BACKGROUND

• 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.

  PMID: 30530452 BACKGROUND

• 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.

  PMID: 37803393 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Anne Germain

  Noctem, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Germain, PhD

CONTACT

(412) 897-3183; anne@noctemhealth.com

Megan Wolfson, LCSW

CONTACT

(412) 360-4878; megan@noctemhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NOCTEM Founder & CEO

Model Details: Participants will be randomized to one of two study arms (COAST-enhanced CBTI or insomnia care as usual) at the site level.

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 5, 2022
• Study Start: August 16, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)