NCT06004869

Incorporating EMA and EMI Into CBT-I Using mHealth and Wearable Technologies

Incorporating Ecological Momentary Assessment and Intervention Into Cognitive Behavioural Therapy for Insomnia Using mHealth and Wearable Technologies: A Pilot Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will be a randomised controlled trial to investigate an integrated platform that incorporates ecological momentary assessments/interventions (EMA/I) into cognitive behavioural therapy for insomnia (CBT-I) using mHealth and wearable technology. The intervention is a promising prospect to address current challenges in the context of sleep medicine to provide real-time and real-world intervention with accuracy, low cost, and easy accessibility.

Detailed description

It will be a randomised, assessor-blind controlled trial embedding both outcome and process evaluation, of the EMA/I CBT-I in conjunction with wearable sensors. The outcome evaluation will examine the treatment effect of EMA/I CBT-I compared with care-as-usual (CAU), whilst process evaluation will enhance the understanding of the causal assumptions that underpin EMA/I CBT-I to inform policy and clinical practice. 60 eligible participants will be randomly assigned to the EMA/I CBT-I group and CAU in a 1:1 allocation ratio. The participants in the EMA/I CBT-I group will receive 6 weeks of smartphone-based EMA/I CBT-I supported by a therapist. The trained therapist will prescribe EMI, provide personalised sleep advice, and adjust the treatment by dynamically adapting real-time rest-activity assessments collected using EMA and wearable devices. Assessments will be managed by an independent assessor (a research assistant) who is blind to group allocation at baseline, week 7 (1 week after treatment), and week 18 (12 weeks after treatment). The proposed study will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and will be registered on ClinicalTrials.gov to ensure compliance with study design and results reporting requirements. The treatment will be provided free of charge.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I)	an integrated system based on an existing multicomponent cognitive behavioural therapy for insomnia (CBT-I) and EMA app
BEHAVIORAL	Self-help cognitive behavioural therapy for insomnia	An mobile app that delivers CBT-I content.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2023-08-22
• Last updated: 2023-08-23