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

NCT06004869 | Unknown

• 1 other identifier: PSY031
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Insomnia

Keywords

ecological momentary intervention

Outcome Measures

Primary Outcomes (1)

• Changes in Insomnia Severity Index (ISI)

  ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5- point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeable impairment attributed to the sleep problem, and level of distress caused by the sleep problem.

  Baseline, Immediate post-treatment, 12-week follow up

Secondary Outcomes (10)

• Changes in the Pittsburgh Sleep Quality Index (PSQI-19)

  Baseline, Immediate post-treatment, 12-week follow up

• Changes in 7-Day Consensus Sleep Diary

  Baseline, Immediate post-treatment, 12-week follow up

• Changes in Hospital Anxiety and Depression Scale (HADS)

  Baseline, Immediate post-treatment, 12-week follow up

• Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)

  Baseline, Immediate post-treatment, 12-week follow up

• Changes in the Epworth Sleepiness Scale (ESS)

  Baseline, Immediate post-treatment, 12-week follow up

Study Arms (3)

EMA/I CBT-I group

EXPERIMENTAL

The participants allocated to the EMI/A CBT-I group will receive 6 weeks of smartphone-based CBT-I for approximately 1 hour per week. The EMA feature will capture the participant's momentary ratings of experiences to support therapeutic decision making. 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. The participants will receive tailored moment-specific feedback from therapists when daytime symptoms are indicated. Therapists will also monitor the relationship between daytime symptoms (EMA app) and the sleep-wake pattern (wearables).

Behavioral: Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I)

Pure self-help CBT-I group

ACTIVE COMPARATOR

The participants in the pure self-help CBT-I group will receive 6 weeks of self-help CBT-I without EMA/I and therapist support. The CBT-I content will be identical to the content used in the EMI/A CBT-I group.

Behavioral: Self-help cognitive behavioural therapy for insomnia

Care as usual

NO INTERVENTION

Interventions

Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I) BEHAVIORAL

an integrated system based on an existing multicomponent cognitive behavioural therapy for insomnia (CBT-I) and EMA app

EMA/I CBT-I group

Self-help cognitive behavioural therapy for insomnia BEHAVIORAL

An mobile app that delivers CBT-I content.

Pure self-help CBT-I group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ecological Momentary Assessment; Methods; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Investigative Techniques; Behavior Therapy; Psychotherapy

Central Study Contacts

Vincent Lam

CONTACT

39436575; pmhlab@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 22, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-08