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Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

Primary Purpose

Chronic Insomnia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
COAST-enhanced CBTI
Military Treatment Facility Insomnia Care As Usual
Sponsored by
Noctem, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Cognitive Behavioral Therapy for Insomnia (CBTI), Digital Technology, Adherence Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    COAST-enhanced CBTI

    Military Treatment Facility Insomnia Care As Usual

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Insomnia Severity
    Insomnia Severity Index (ISI)
    Insomnia Severity
    Insomnia Severity Index (ISI)
    Insomnia Severity
    Insomnia Severity Index (ISI)
    Symptoms of Depression
    Patient Health Questionnaire-2 (PHQ-2)
    Symptoms of Depression
    Patient Health Questionnaire-2 (PHQ-2)
    Symptoms of Depression
    Patient Health Questionnaire-2 (PHQ-2)
    Symptoms of Anxiety
    Generalized Anxiety Disorder 2-item (GAD-2)
    Symptoms of Anxiety
    Generalized Anxiety Disorder 2-item (GAD-2)
    Symptoms of Anxiety
    Generalized Anxiety Disorder 2-item (GAD-2)
    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).
    Satisfaction with Insomnia Care
    Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 30, 2022
    Last Updated
    July 12, 2023
    Sponsor
    Noctem, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05490550
    Brief Title
    Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)
    Official Title
    Comparing Insomnia Care As Usual to Digital Augmentation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Noctem, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this pragmatic multi-site 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Insomnia
    Keywords
    Insomnia, Cognitive Behavioral Therapy for Insomnia (CBTI), Digital Technology, Adherence Monitoring

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomized to one of two study arms (COAST-enhanced CBTI or insomnia care as usual) at the site level.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    188 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    COAST-enhanced CBTI
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Military Treatment Facility Insomnia Care As Usual
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    COAST-enhanced CBTI
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Military Treatment Facility Insomnia Care As Usual
    Intervention Description
    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 Information:
    Title
    Insomnia Severity
    Description
    Insomnia Severity Index (ISI)
    Time Frame
    baseline
    Title
    Insomnia Severity
    Description
    Insomnia Severity Index (ISI)
    Time Frame
    6-8 week check-in
    Title
    Insomnia Severity
    Description
    Insomnia Severity Index (ISI)
    Time Frame
    3-month follow up
    Title
    Symptoms of Depression
    Description
    Patient Health Questionnaire-2 (PHQ-2)
    Time Frame
    baseline
    Title
    Symptoms of Depression
    Description
    Patient Health Questionnaire-2 (PHQ-2)
    Time Frame
    6-8 week check-in
    Title
    Symptoms of Depression
    Description
    Patient Health Questionnaire-2 (PHQ-2)
    Time Frame
    3-month follow up
    Title
    Symptoms of Anxiety
    Description
    Generalized Anxiety Disorder 2-item (GAD-2)
    Time Frame
    baseline
    Title
    Symptoms of Anxiety
    Description
    Generalized Anxiety Disorder 2-item (GAD-2)
    Time Frame
    6-8 week check-in
    Title
    Symptoms of Anxiety
    Description
    Generalized Anxiety Disorder 2-item (GAD-2)
    Time Frame
    3-month follow up
    Title
    Acceptability of Insomnia Care
    Description
    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).
    Time Frame
    6-8 week check-in
    Title
    Satisfaction with Insomnia Care
    Description
    Client Satisfaction Questionnaire assessing perceived quality of care, services, and clinicians encountered during treatment.
    Time Frame
    6-8 week check in

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anne Germain, PhD
    Phone
    (412) 897-3183
    Email
    anne@noctemhealth.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megan Wolfson, LCSW
    Phone
    (412) 360-4878
    Email
    megan@noctemhealth.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anne Germain
    Organizational Affiliation
    Noctem, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33164742
    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.
    Results Reference
    background
    PubMed Identifier
    30530452
    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.
    Results Reference
    background

    Learn more about this trial

    Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)

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