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Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application (STELLAR)

Primary Purpose

Insomnia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 years or older Daily access to a computer or smartphone with reliable internet connection Exclusion Criteria: Currently pregnant or planning to become pregnant in the next year Visual impairment that prevents use of a computer Serious health conditions that will prevent taking part in the study over the next 3 - 6 months, such as severe medical or psychiatric disease, such as treatments for cancer or congestive heart failure, OR a condition that may require hospitalization or surgery Self-reported history of drowsy driving or fallen asleep while driving Night shift worker Prior exposure to Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment Insomnia severity index score < 14

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I) with general sleep education

    General Sleep Education

    Arm Description

    Outcomes

    Primary Outcome Measures

    Insomnia Severity Index (ISI)
    Mean change in Insomnia Severity Index (ISI) score from baseline to end of intervention. Score ranges from 0 to 28, with higher scores indicating a worse outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2023
    Last Updated
    August 16, 2023
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05991492
    Brief Title
    Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
    Acronym
    STELLAR
    Official Title
    Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    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
    Insomnia is an important public health problem and the most common sleep disorder in the general population. Up to 20% of adults in the United States suffer from insomnia disorder, and it has been associated with increased morbidity, mortality, and healthcare costs. Cognitive behavioral therapy for insomnia (CBT-I) is the initial recommended treatment approach for insomnia. Combined therapy with CBT-I and medication has shown no advantage over CBT-I alone. CBT-I is not always accessible to patients, however, due to cost and availability of trained healthcare professionals. Web-based CBT-I is an inexpensive and effective self-management tool for treatment of insomnia. This pilot study would test the efficacy of a new digital CBT-I application called Stellar Sleep, a cost effective and user-friendly version of wCBT-I, in patients with insomnia. This is the first digital CBT-I app that allows automatic entry of sleep diary data from wearable devices that track sleep (such as the Mi Band 5 or a FitBit, for instance). Testing the efficacy of this application will provide the preliminary data necessary for larger trials to further validate the application and determine its role for future patients. Use of this application can help bridge the gap in providing care to insomnia patients with transportation and cost barriers and to accommodate the long wait times for traditional in-person CBT-I. It will also be the first web-based CBT-I application that can directly upload data from a wearable device.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I) with general sleep education
    Arm Type
    Active Comparator
    Arm Title
    General Sleep Education
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I
    Intervention Description
    Digital insomnia treatment
    Primary Outcome Measure Information:
    Title
    Insomnia Severity Index (ISI)
    Description
    Mean change in Insomnia Severity Index (ISI) score from baseline to end of intervention. Score ranges from 0 to 28, with higher scores indicating a worse outcome.
    Time Frame
    6-8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years or older Daily access to a computer or smartphone with reliable internet connection Exclusion Criteria: Currently pregnant or planning to become pregnant in the next year Visual impairment that prevents use of a computer Serious health conditions that will prevent taking part in the study over the next 3 - 6 months, such as severe medical or psychiatric disease, such as treatments for cancer or congestive heart failure, OR a condition that may require hospitalization or surgery Self-reported history of drowsy driving or fallen asleep while driving Night shift worker Prior exposure to Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment Insomnia severity index score < 14
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michelle Reid
    Phone
    5164760541
    Email
    mlreid@bwh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

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