Recruiting

Digital Augmentation

Sponsor:

Noctem, LLC

Code:

NCT05490550

Conditions

Chronic Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COAST-enhanced CBTI

Military Treatment Facility Insomnia Care As Usual

Study Details

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

Study ID

NCT05490550

Start date

Aug 16, 2023

Status verified date

Mar, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Insomnia Severity [ Time Frame: baseline ]
  • Insomnia Severity [ Time Frame: 6-8 week check-in ]
  • Insomnia Severity [ Time Frame: 3-month follow up ]
  • Symptoms of Depression [ Time Frame: baseline ]
  • Symptoms of Depression [ Time Frame: 6-8 week check-in ]
  • Symptoms of Depression [ Time Frame: 3-month follow up ]
  • Symptoms of Anxiety [ Time Frame: baseline ]
  • Symptoms of Anxiety [ Time Frame: 6-8 week check-in ]
  • Symptoms of Anxiety [ Time Frame: 3-month follow up ]
  • Acceptability of Insomnia Care [ Time Frame: 6-8 week check-in ]
  • Satisfaction with Insomnia Care [ Time Frame: 6-8 week check in ]

Central Contacts and Locations

Central contacts

Anne Germain, PhD

(412) 897-3183anne@noctemhealth.com

Megan Wolfson, LCSW

(412) 360-4878megan@noctemhealth.com

Locations

Madigan Army Medical Center

Recruiting

Lakewood, Washington, United States, 98431

More Information

Sponsor

Noctem, LLC

Last update posted

Mar 21, 2024

Last verified

Mar, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Noctem, LLC on 2024-03-21.