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

Not Applicable

Recruiting

• Conditions: Dementia

• Registration Number: NCT05634317
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-10
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-29
• Last Update Submitted: 2022-11-29
• Study First Posted: 2022-12-02
• Last Update Posted: 2022-12-02
• Primary Completion: 2024-12-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
The 9-item Chinese version of the Patient Health Questionnaire 9 (PHQ-9)	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))	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

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	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 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
The WHOQOL-OLD BREF (HK)	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) 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
Positive Aspect of Caregiving scale (PAC)	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 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
Perceived caregiving stress (PSS)	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))	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

Trial Locations

Locations (1)

The Hong Kong Polytechnic Univeristy; 🇭🇰 Hong Kong, Hong Kong