Supporting Caregivers of PWD and Identifying an Effective Intervention to Reduce Their Depressive Symptoms

Study Overview
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Brief Summary
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Effective clinical management of chronic conditions like depressive symptoms of caregivers actually requires a sequence of interventions, each adapts to responses to prior interventions, and hence multiple intervention decisions throughout the whole careers of dementia caregivers. The main objective of this study is to build the capacity in the community to support the family caregivers of PWD and identify a 2-stage adaptive intervention involving behavioral activation and mindfulness practice to reduce their depressive symptoms using SMART design. 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. The findings will inform us whether the SMART is efficient in identifying an effective adaptive intervention for reducing depressive symptoms. More importantly, will also show us how to alleviate the negative impact of caregiving in the family caregivers.

Detailed Description
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Aims The main objective of this study is to build the capacity in the community to support the family caregivers of PWD and identify a 2-stage adaptive intervention involving behavioral activation and mindfulness practice to reduce their depressive symptoms using SMART design. Using a sequential multiple randomized trial (SMART), we aim to investigate whether (1) the smartphone-delivered behavioral activation (SD-BA) or smartphone-delivered mindfulness practice (SD- MP) is more effective for reducing depressive symptoms as the first-stage intervention; (2) evaluate whether extending the original first stage intervention with an additional self-efficacy enhancing component or switching to an alternative intervention is more effective in reducing depressive symptoms when participants are not responding to the first stage intervention; (3) evaluate the sequence of the intervention, SD-BA followed by SD-MP or SD-MP followed by SD-BA is more effective in reducing depressive symptoms; and 4) identify which of our four embedded adaptive interventions (SD- BA with booster for responders and (SD-BA for nonresponses; SD-BA with booster for responders and SD-MP for no responders; SD-MY with booster for responders and SD-MP for non-responders; SD-MP with booster for responders and SD-BA for non-responders) is the most effective for reducing depressive symptoms. 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.

Official Title
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Supporting Family Caregivers of People With Dementia and Identifying an Effective Adaptive Intervention to Reduce Their Depressive Symptoms: a Sequential Multiple Assignment Randomized Trial

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Smartphone delivered Behavioral activation
* Behavioral: Smartphone delivered Mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 or above FC of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community; having been providing care for at least 3 months prior to recruitment the presence of mild-to- moderate depressive symptoms (Patient Health Questionnaire-9 (PHQ-9) score 5 to 14). Exclusion Criteria: having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention 6 months prior to recruitment 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral activation<br>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. | Behavioral: Smartphone delivered Behavioral activation<br>* 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<br>|
| Active Comparator: Mindfulness<br>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. | Behavioral: Smartphone delivered Mindfulness<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 9-item Chinese version of the Patient Health Questionnaire 9 (PHQ-9) | PHQ-9* is a 9-question instrument to screen for depression. It requires participants to answer their depression experiences over the past 2 weeks. Comparisons of changes of the Patient Health Questionnaire 9 will be considered as follows: T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5 | baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5)) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived caregiving stress (PSS) | Perceived Stress Scale contains 10 items with 5-point Likert-type scale rating from 0 (never) to 4 (very often). The total score can range from 0 to 40 with higher scores indicating higher perceived stress. Comparisons of changes of the perceived caregiving stress will be considered as follows: T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5 | baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5)) | 
| Positive Aspect of Caregiving scale (PAC) | The PAC scale demonstrates the acceptable levels of internal consistency Cronbach's alpha 0.85 among the family caregivers of PWD in Hong Kong. Higher scores indicating more positive self-perceptions of caregiving. Comparisons of changes of the positive aspect of caregiving scale will be considered as follows: T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5 | baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5)) | 
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Comparisons of changes of the Pittsburgh sleep quality index will be considered as follows: T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5 | baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5)) | 
| The WHOQOL-OLD BREF (HK) | The WHOQOL-OLD BREF (HK) comprised 28 items and each item is rated on a 5-point Likert-type scale that ranged from 1 (very dissatisfied) to 5 (very satisfied), with a higher score indicating a better QoL. Comparisons of changes of the WHOQOL-OLD BREF (HK) will be considered as follows: T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5 | baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5)) |