Clinical trial NCT05490550: Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)
Official title: Comparing Insomnia Care As Usual to Digital Augmentation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Keywords: Insomnia
Cognitive Behavioral Therapy for Insomnia (CBTI)
Digital Technology
Adherence Monitoring
Lead sponsor: Noctem, LLC
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two study arms (COAST-enhanced CBTI or insomnia care as usual) at the site level.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity
timeFrame: baseline
measure: Insomnia Severity
timeFrame: 6-8 week check-in
measure: Insomnia Severity
timeFrame: 3-month follow up
measure: Symptoms of Depression
timeFrame: baseline
measure: Symptoms of Depression
timeFrame: 6-8 week check-in
measure: Symptoms of Depression
timeFrame: 3-month follow up
measure: Symptoms of Anxiety
timeFrame: baseline
measure: Symptoms of Anxiety
timeFrame: 6-8 week check-in
measure: Symptoms of Anxiety
timeFrame: 3-month follow up
measure: Acceptability of Insomnia Care
timeFrame: 6-8 week check-in
measure: Satisfaction with Insomnia Care
timeFrame: 6-8 week check in
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Noctem, LLC
name: Anne Germain
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.