Clinical trial NCT05634317: Supporting Caregivers of PWD and Identifying an Effective Intervention to Reduce Their Depressive Symptoms
Official title: Supporting Family Caregivers of People With Dementia and Identifying an Effective Adaptive Intervention to Reduce Their Depressive Symptoms: a Sequential Multiple Assignment Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. aged 18 or above
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:

1. having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention 6 months prior to recruitment
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).

Primary outcomes:
measure: The 9-item Chinese version of the Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 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 outcomes:
measure: Perceived caregiving stress (PSS)
timeFrame: 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))
measure: Positive Aspect of Caregiving scale (PAC)
timeFrame: 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))
measure: Pittsburgh Sleep Quality Index
timeFrame: 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))
measure: The WHOQOL-OLD BREF (HK)
timeFrame: 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))
Other outcomes:
measure: Five Facets Mindfulness Questionnaire-Short Form
timeFrame: 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))
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic Univeristy
Study officials:
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