Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

Chronic Insomnia Clinical Trial

Official title:

Comparing Insomnia Care As Usual to Digital Augmentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490550
• Other study ID #: JW210372
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2023
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Noctem, LLC
• Contact: Anne Germain, PhD
• Phone: (412) 897-3183
• Email: anne[@]noctemhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Lakewood	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Noctem, LLC

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity	Insomnia Severity Index (ISI)	baseline
Primary	Insomnia Severity	Insomnia Severity Index (ISI)	6-8 week check-in
Primary	Insomnia Severity	Insomnia Severity Index (ISI)	3-month follow up
Primary	Symptoms of Depression	Patient Health Questionnaire-2 (PHQ-2)	baseline
Primary	Symptoms of Depression	Patient Health Questionnaire-2 (PHQ-2)	6-8 week check-in
Primary	Symptoms of Depression	Patient Health Questionnaire-2 (PHQ-2)	3-month follow up
Primary	Symptoms of Anxiety	Generalized Anxiety Disorder 2-item (GAD-2)	baseline
Primary	Symptoms of Anxiety	Generalized Anxiety Disorder 2-item (GAD-2)	6-8 week check-in
Primary	Symptoms of Anxiety	Generalized Anxiety Disorder 2-item (GAD-2)	3-month follow up
Primary	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
Primary	Satisfaction with Insomnia Care	Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment.	6-8 week check in