Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

NCT ID: NCT05991492

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-13
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Digital insomnia treatment

General Sleep Education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Digital insomnia treatment

Intervention Type: DEVICE

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 < 12

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sogol Javaheri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2023P001950

Identifier Type: -

Identifier Source: org_study_id