Supporting Caregivers of PWD and Identifying an Effective Intervention to Reduce Their Depressive Symptoms
NCT ID: NCT05634317
Last Updated: 2022-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
136 participants
INTERVENTIONAL
2022-10-01
2025-09-01
Brief Summary
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Detailed Description
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Methods A random sample of 272 family caregivers of PWD who meet the clinical criteria of subthreshold depression will be recruited. Participants will be assessed at T1 (baseline assessment); T2 (immediately after the first stage intervention); T3 (immediately after the 2nd stage intervention); T4 (3 months after the 2nd stage intervention); T5 (6 months after the 2nd stage intervention) with various health-related outcomes.
Significance and value The findings will not only inform us whether the SMART is an efficient approach for identifying an effective adaptive intervention for reducing depressive symptoms, but , more importantly will also show us how to alleviate the negative impact of caregiving in the family caregivers.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Behavioral activation
The SD-BA, consisting of 16 sessions (30 minutes each) twice a week over 8 weeks, will be delivered by the trained instructor through a videoconference mobile app. Participants will be asked to review their daily activity patterns and then choose activity goals and review their successes and areas of improvement. They will also be taught how to fill out the daily monitoring record, which will involve noting down their activities on the day of the session for each hour before the session, and rating the importance and degree of enjoyment associated with each activity.
Smartphone delivered Behavioral activation
Outline:
Session 0 45-minute psychoeducation on caregiving and depression
Session 1 Review the present use of time and use the monitoring form
Session 2 Brain-storm pleasant events and schedule pleasant activities
Session 3 Review scheduling of events and discuss how to improve
Session 4 Review modifications and consolidate gains on scheduling
Session 5 Review present social support and explore new sources of support
Session 6 Examine communication skills and explore new options
Session 7 Review new communications and discuss how to improve
Session 8 Review modification and consolidate gains on support
Mindfulness
A mindfulness instructor will deliver the program through a videoconference mobile app, and include various mindfulness practices (e.g., mindful walking, body scanning) and sharing. To standardize the interventions in this study, the previous approach will be changed from 7 weekly 120-minute sessions to 16 sessions (30 minutes each) twice a week over 8 weeks. The participants will also be encouraged to perform 30 minutes of mindfulness practice every day. All participants will be given an audio (mp3) recording of guided mindfulness activities to enhance their daily practice, and a logbook via a mobile app or in hardcopy (according to their preference) to record the frequency of their self-practice at home and monitor their compliance rate. Our volunteers will provide support via smartphone to answer questions and address difficulties.
Smartphone delivered Mindfulness
Outline:
Session 0 45-minute psychoeducation on caregiving and depression
Session 1 The Raisin exercise (eating meditation) and12-min body scan
Session 2 Exercises on thoughts and feelings 12-min body scan
Session 3 Exercises focusing on unpleasant experiences, practicing seeing and hearing , sitting meditation, 3-min breathing space, and mindful stretching and breath meditation
Session 4 Practicing seeing and hearing, mindful communication, 3-min breathing space, and sitting meditation
Session 5 Mindful walking, 3-min breathing space, and sitting meditation
Session 6 Sitting meditation, exercises on thoughts and alternative viewpoints, and 3-min breathing space (responsive)
Session 7 Sitting meditation, activity and mood exercise, identifying habitual emotional reactions to difficulties, and 3-min breathing space (responsive)
Session 8 12-min body scan, exercise on looking forward, and exercise on preparing for the future
Interventions
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Smartphone delivered Behavioral activation
Outline:
Session 0 45-minute psychoeducation on caregiving and depression
Session 1 Review the present use of time and use the monitoring form
Session 2 Brain-storm pleasant events and schedule pleasant activities
Session 3 Review scheduling of events and discuss how to improve
Session 4 Review modifications and consolidate gains on scheduling
Session 5 Review present social support and explore new sources of support
Session 6 Examine communication skills and explore new options
Session 7 Review new communications and discuss how to improve
Session 8 Review modification and consolidate gains on support
Smartphone delivered Mindfulness
Outline:
Session 0 45-minute psychoeducation on caregiving and depression
Session 1 The Raisin exercise (eating meditation) and12-min body scan
Session 2 Exercises on thoughts and feelings 12-min body scan
Session 3 Exercises focusing on unpleasant experiences, practicing seeing and hearing , sitting meditation, 3-min breathing space, and mindful stretching and breath meditation
Session 4 Practicing seeing and hearing, mindful communication, 3-min breathing space, and sitting meditation
Session 5 Mindful walking, 3-min breathing space, and sitting meditation
Session 6 Sitting meditation, exercises on thoughts and alternative viewpoints, and 3-min breathing space (responsive)
Session 7 Sitting meditation, activity and mood exercise, identifying habitual emotional reactions to difficulties, and 3-min breathing space (responsive)
Session 8 12-min body scan, exercise on looking forward, and exercise on preparing for the future
Eligibility Criteria
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Inclusion Criteria
2. FC of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community;
3. having been providing care for at least 3 months prior to recruitment
4. the presence of mild-to- moderate depressive symptoms (Patient Health Questionnaire-9 (PHQ-9) score 5 to 14).
Exclusion Criteria
2. having acute psychiatric and medical comorbidities that are potentially life- threatening or would limit the caregivers' participation or adherence (e.g., suicidal ideation, acute psychosis).
18 Years
ALL
Yes
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Patrick KOR Pui Kin
Assistant Professor, School of nursing
Locations
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The Hong Kong Polytechnic Univeristy
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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TBC
Identifier Type: -
Identifier Source: org_study_id
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