InsomniaNCT06004869
Incorporating EMA and EMI Into CBT-I Using mHealth and Wearable Technologies
A study testing Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I) and Self-help cognitive behavioural therapy for insomnia in people with Insomnia, run by Chinese University of Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I) and Self-help cognitive behavioural therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Incorporating Ecological Momentary Assessment and Intervention Into Cognitive Behavioural Therapy for Insomnia Using mHealth and Wearable Technologies: A Pilot Randomised Controlled Trial
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.
Read the 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
- Being tested
- Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I), Self-help cognitive behavioural therapy for insomnia
- Keywords
- ecological momentary intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I)Behavioural
an integrated system based on an existing multicomponent cognitive behavioural therapy for insomnia (CBT-I) and EMA app
Self-help cognitive behavioural therapy for insomniaBehavioural
An mobile app that delivers CBT-I content.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Self-help cognitive behavioural therapy for insomnia |
| Care as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Immediate post-treatment, 12-week follow up
Secondary outcomes (10)
Changes in the Pittsburgh Sleep Quality Index (PSQI-19)
The PSQI-19 is a 19-item questionnaire used for measuring and identifying the quality of sleep. It provides a measure of global sleep quality, including sleep latency, sleep duration, habitual sleep efficiency and sleep disturbances.
Measured: Baseline, Immediate post-treatment, 12-week follow up
Changes in 7-Day Consensus Sleep Diary
The standardized sleep diary records sleep-onset latency (SOL; min), wake after sleep onset (WASO; min), total wake time (TWT; min), total sleep time (TST; min), time in bed (TIB; min), etc.
Measured: Baseline, Immediate post-treatment, 12-week follow up
Changes in Hospital Anxiety and Depression Scale (HADS)
A 14-item self-rating scale that measures anxiety and depression in both hospital and community settings. It is divided into an Anxiety subscale (HADS-A) and a Depression subscale (HADS-D) both containing seven intermingled items. It is for screening purposes and is not meant to be a diagnostic tool. HADS scores of 8-10, 11-14, and 15-21 represent mild, moderate, and severe anxiety and depression separately.
Measured: Baseline, Immediate post-treatment, 12-week follow up
Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
The DBAS is a 16-item questionnaire used to assess sleep-related cognitions.
Measured: Baseline, Immediate post-treatment, 12-week follow up
Changes in the Epworth Sleepiness Scale (ESS)
The ESS is an 8-item scale designed to evaluate overall daytime sleepiness.
Measured: Baseline, Immediate post-treatment, 12-week follow up
Changes in Multidimensional Fatigue Inventory (MFI)
A 20-item self-report instrument designed to measure fatigue. Ratings on a 5-point Likert scale are obtained on the dimensions of general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Scores on each subscale range from 4 to 20, with higher scores indicating greater fatigue.
Measured: Baseline, Immediate post-treatment, 12-week follow up
Changes in Short Form (Six-Dimension) Health Survey (SF-6D)
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state).
Measured: Baseline, Immediate post-treatment, 12-week follow up
Changes in Sheehan Disability Scale (SDS)
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Measured: Baseline, Immediate post-treatment, 12-week follow up
Changes in Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Measured: Baseline, Immediate post-treatment
Changes in Insomnia Treatment Acceptability Scale (ITAS)
The 8-item Insomnia Treatment Acceptability Scale (ITAS) may examine treatment acceptability. Respondents would score each item from 0 (not at all acceptable) to 4 (very acceptable) to rate if the rationale made sense, how acceptable the treatment was for them, suitability for their sleep problem, and expected effectiveness for their sleep problem.
Measured: Baseline, Immediate post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004869
- Sponsor's protocol ID
- PSY031
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Ecological Momentary Assessment and Intervention Into Cognitive Behavioural Therapy for Insomnia Using mHealth and Wearable Technologies: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06004869
- Acronym / sponsor ID
- PSY031
- Conditions
- Insomnia
- Keywords
- ecological momentary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMA/I CBT-I group | Experimental | Behavioral: Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I)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). |
| Pure self-help CBT-I group | Active comparator | Behavioral: Self-help cognitive behavioural therapy for insomniaThe 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. |
| Care as usual | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | EMA/I CBT-I group |
| Self-help cognitive behavioural therapy for insomniaAn mobile app that delivers CBT-I content. | Behavioural | Pure self-help CBT-I group |
Primary outcome
Changes in Insomnia Severity Index (ISI)
Time frame: Baseline, Immediate post-treatment, 12-week follow up
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.
10 secondary outcomes
Changes in the Pittsburgh Sleep Quality Index (PSQI-19)
Time frame: Baseline, Immediate post-treatment, 12-week follow up
Changes in 7-Day Consensus Sleep Diary
Time frame: Baseline, Immediate post-treatment, 12-week follow up
Changes in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Immediate post-treatment, 12-week follow up
Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
Time frame: Baseline, Immediate post-treatment, 12-week follow up
Changes in the Epworth Sleepiness Scale (ESS)
Time frame: Baseline, Immediate post-treatment, 12-week follow up
Changes in Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, Immediate post-treatment, 12-week follow up
Changes in Short Form (Six-Dimension) Health Survey (SF-6D)
Time frame: Baseline, Immediate post-treatment, 12-week follow up
Changes in Sheehan Disability Scale (SDS)
Time frame: Baseline, Immediate post-treatment, 12-week follow up
Changes in Credibility-Expectancy Questionnaire (CEQ)
Time frame: Baseline, Immediate post-treatment
Changes in Insomnia Treatment Acceptability Scale (ITAS)
Time frame: Baseline, Immediate post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I) and Self-help cognitive behavioural therapy for insomnia in people with Insomnia, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Lam (39436575, pmhlab@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Insomnia Severity Index (ISI) (time frame: Baseline, Immediate post-treatment, 12-week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.