xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06004869</url>
    </required_header>
    <id_info>
      <org_study_id>PSY031</org_study_id>
      <nct_id>NCT06004869</nct_id>
    </id_info>
    <brief_title>Incorporating EMA and EMI Into CBT-I Using mHealth and Wearable Technologies</brief_title>
    <official_title>Incorporating Ecological Momentary Assessment and Intervention Into Cognitive Behavioural Therapy for Insomnia Using mHealth and Wearable Technologies: A Pilot Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese University of Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese University of Hong Kong</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will be a randomised controlled trial to investigate an integrated platform that&#xD;
        incorporates ecological momentary assessments/interventions (EMA/I) into cognitive&#xD;
        behavioural therapy for insomnia (CBT-I) using mHealth and wearable technology. The&#xD;
        intervention is a promising prospect to address current challenges in the context of sleep&#xD;
        medicine to provide real-time and real-world intervention with accuracy, low cost, and easy&#xD;
        accessibility.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It will be a randomised, assessor-blind controlled trial embedding both outcome and process&#xD;
        evaluation, of the EMA/I CBT-I in conjunction with wearable sensors. The outcome evaluation&#xD;
        will examine the treatment effect of EMA/I CBT-I compared with care-as-usual (CAU), whilst&#xD;
        process evaluation will enhance the understanding of the causal assumptions that underpin&#xD;
        EMA/I CBT-I to inform policy and clinical practice. 60 eligible participants will be randomly&#xD;
        assigned to the EMA/I CBT-I group and CAU in a 1:1 allocation ratio. The participants in the&#xD;
        EMA/I CBT-I group will receive 6 weeks of smartphone-based EMA/I CBT-I supported by a&#xD;
        therapist. The trained therapist will prescribe EMI, provide personalised sleep advice, and&#xD;
        adjust the treatment by dynamically adapting real-time rest-activity assessments collected&#xD;
        using EMA and wearable devices. Assessments will be managed by an independent assessor (a&#xD;
        research assistant) who is blind to group allocation at baseline, week 7 (1 week after&#xD;
        treatment), and week 18 (12 weeks after treatment). The proposed study will follow the&#xD;
        recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and will be&#xD;
        registered on ClinicalTrials.gov to ensure compliance with study design and results reporting&#xD;
        requirements. The treatment will be provided free of charge.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in Insomnia Severity Index (ISI)</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in the Pittsburgh Sleep Quality Index (PSQI-19)</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in 7-Day Consensus Sleep Diary</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Hospital Anxiety and Depression Scale (HADS)</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>The DBAS is a 16-item questionnaire used to assess sleep-related cognitions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the Epworth Sleepiness Scale (ESS)</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>The ESS is an 8-item scale designed to evaluate overall daytime sleepiness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Multidimensional Fatigue Inventory (MFI)</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Short Form (Six-Dimension) Health Survey (SF-6D)</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Sheehan Disability Scale (SDS)</measure>
      <time_frame>Baseline, Immediate post-treatment, 12-week follow up</time_frame>
      <description>SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Credibility-Expectancy Questionnaire (CEQ)</measure>
      <time_frame>Baseline, Immediate post-treatment</time_frame>
      <description>The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Insomnia Treatment Acceptability Scale (ITAS)</measure>
      <time_frame>Baseline, Immediate post-treatment</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>EMA/I CBT-I group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pure self-help CBT-I group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Care as usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I)</intervention_name>
      <description>an integrated system based on an existing multicomponent cognitive behavioural therapy for insomnia (CBT-I) and EMA app</description>
      <arm_group_label>EMA/I CBT-I group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Self-help cognitive behavioural therapy for insomnia</intervention_name>
      <description>An mobile app that delivers CBT-I content.</description>
      <arm_group_label>Pure self-help CBT-I group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Hong Kong residents at least 18 years of age;&#xD;
  &#xD;
            2. able to read Chinese and type in Chinese or English;&#xD;
  &#xD;
            3. meet the DSM-5 diagnostic criteria of insomnia disorder (difficulty initiating and/or&#xD;
               maintaining sleep or early morning awakening, alongside clinically significant daytime&#xD;
               impairment) based on the Brief Insomnia Questionnaire (BIQ), a diagnostic tool&#xD;
               validated by the team;&#xD;
  &#xD;
            4. have an Insomnia Severity Index (ISI) score of at least 10 indicating clinical-level&#xD;
               insomnia;&#xD;
  &#xD;
            5. have adequate opportunity and circumstances for sleep to occur;&#xD;
  &#xD;
            6. have an Internet-enabled mobile device (iOS or Android operating system), and&#xD;
  &#xD;
            7. are willing to provide informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          To mimic real-world settings, a less stringent set of exclusion criteria will be adopted.&#xD;
  &#xD;
            1. A Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current&#xD;
               moderate suicidal risk that requires active crisis management (referral information to&#xD;
               professional services will be provided to those with serious suicidal risk);&#xD;
  &#xD;
            2. involvement in CBT-I in the past 6 months;&#xD;
  &#xD;
            3. a history of severe mental illness (e.g., bipolar disorder, psychotic disorder);&#xD;
  &#xD;
            4. major medical or neurocognitive disorders or side effects of medication that&#xD;
               contribute significantly to insomnia or make participation infeasible based on the&#xD;
               team's clinical experience;&#xD;
  &#xD;
            5. other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA),&#xD;
               and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the&#xD;
               cut-off scores (≥7 on narcolepsy; ≥15 on OSA; ≥7 on RLS/PLMD) in SLEEP-50;&#xD;
  &#xD;
            6. taking over-the-counter medication or psychotropic drugs that target insomnia within 2&#xD;
               weeks prior to the baseline assessment; and&#xD;
  &#xD;
            7. shift work, pregnancy, family or other commitments that interfere with regular&#xD;
               sleep-wake patterns.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Vincent Lam</last_name>
      <phone>39436575</phone>
      <email>pmhlab@cuhk.edu.hk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
      <investigator_full_name>Fiona YY Ho</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>ecological momentary intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004869
  org study id: PSY031
  nct id: NCT06004869
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Changes in Insomnia Severity Index (ISI)
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: 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.
  measure: Changes in the Pittsburgh Sleep Quality Index (PSQI-19)
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: 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.
  measure: Changes in 7-Day Consensus Sleep Diary
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: 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.
  measure: Changes in Hospital Anxiety and Depression Scale (HADS)
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: 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.
  measure: Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: The DBAS is a 16-item questionnaire used to assess sleep-related cognitions.
  measure: Changes in the Epworth Sleepiness Scale (ESS)
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: The ESS is an 8-item scale designed to evaluate overall daytime sleepiness.
  measure: Changes in Multidimensional Fatigue Inventory (MFI)
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: 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.
  measure: Changes in Short Form (Six-Dimension) Health Survey (SF-6D)
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: 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).
  measure: Changes in Sheehan Disability Scale (SDS)
  time frame: Baseline, Immediate post-treatment, 12-week follow up
  description: SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
  measure: Changes in Credibility-Expectancy Questionnaire (CEQ)
  time frame: Baseline, Immediate post-treatment
  description: The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
  measure: Changes in Insomnia Treatment Acceptability Scale (ITAS)
  time frame: Baseline, Immediate post-treatment
  description: 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.
  arm group label: EMA/I CBT-I group
  arm group type: Experimental
  description: 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).
  arm group label: Pure self-help CBT-I group
  arm group type: Active Comparator
  description: 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.
  arm group label: Care as usual
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: Ecological momentary assessments/interventions with cognitive behavioural therapy for insomnia (EMA/I CBT-I)
  description: an integrated system based on an existing multicomponent cognitive behavioural therapy for insomnia (CBT-I) and EMA app
  arm group label: EMA/I CBT-I group
  intervention type: Behavioral
  intervention name: Self-help cognitive behavioural therapy for insomnia
  description: An mobile app that delivers CBT-I content.
  arm group label: Pure self-help CBT-I group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Vincent Lam
  phone: 39436575
  email: pmhlab@cuhk.edu.hk
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Fiona YY Ho
  investigator title: Associate Professor
  mesh term: Sleep Initiation and Maintenance Disorders