Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

Insomnia Clinical Trial

— STELLAR  

Official title:

Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05991492
• Other study ID #: 2023P001950
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Brigham and Women's Hospital
• Contact: Michelle Reid
• Phone: 5164760541
• Email: mlreid[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I
Digital insomnia treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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