NCT05634317

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dementia

Interventions

Type	Name	Description
BEHAVIORAL	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
BEHAVIORAL	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

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-12-01
• Completion: 2025-09-01
• First posted: 2022-12-02
• Last updated: 2022-12-02

Locations

1 site across 1 country: Hong Kong