Status:
UNKNOWN
Incorporating EMA and EMI Into CBT-I Using mHealth and Wearable Technologies
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 i...
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...
Eligibility Criteria
Inclusion
- Hong Kong residents at least 18 years of age;
- able to read Chinese and type in Chinese or English;
- meet the DSM-5 diagnostic criteria of insomnia disorder (difficulty initiating and/or maintaining sleep or early morning awakening, alongside clinically significant daytime impairment) based on the Brief Insomnia Questionnaire (BIQ), a diagnostic tool validated by the team;
- have an Insomnia Severity Index (ISI) score of at least 10 indicating clinical-level insomnia;
- have adequate opportunity and circumstances for sleep to occur;
- have an Internet-enabled mobile device (iOS or Android operating system), and
- are willing to provide informed consent.
Exclusion
- To mimic real-world settings, a less stringent set of exclusion criteria will be adopted.
- A Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk);
- involvement in CBT-I in the past 6 months;
- a history of severe mental illness (e.g., bipolar disorder, psychotic disorder);
- major medical or neurocognitive disorders or side effects of medication that contribute significantly to insomnia or make participation infeasible based on the team's clinical experience;
- other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores (≥7 on narcolepsy; ≥15 on OSA; ≥7 on RLS/PLMD) in SLEEP-50;
- taking over-the-counter medication or psychotropic drugs that target insomnia within 2 weeks prior to the baseline assessment; and
- shift work, pregnancy, family or other commitments that interfere with regular sleep-wake patterns.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06004869
Start Date
September 1 2023
End Date
December 31 2024
Last Update
August 23 2023
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