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

Insomnia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT06004869
Study type Interventional
Source Chinese University of Hong Kong
Contact Vincent Lam
Phone 39436575
Email pmhlab@cuhk.edu.hk
Status Not yet recruiting
Phase N/A
Start date September 1, 2023
Completion date December 31, 2024
View Details
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