Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

NCT05991492 | Active Not Recruiting

• 1 other identifier: 2023P001950
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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.

  6-8 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

Device: Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I

General Sleep Education

NO INTERVENTION

Interventions

Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I DEVICE

Digital insomnia treatment

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Daily access to a computer or smartphone with reliable internet connection

You may not qualify if:

• 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 \< 12

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: February 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)