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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Dementia

Treatments: Behavioral: Smartphone delivered Mindfulness; Behavioral: Smartphone delivered Behavioral activation

Study type: Interventional

Funder types: Other

Identifiers

NCT05634317

TBC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Behavioral activation

Experimental group

Description:

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.

Treatment:

Behavioral: Smartphone delivered Behavioral activation

Mindfulness

Active Comparator group

Description:

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.

Treatment:

Behavioral: Smartphone delivered Mindfulness