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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634317
• Other study ID #: TBC
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2022
• Source: The Hong Kong Polytechnic University
• Contact: Patrick Kor
• Phone: 2766 5622
• Email: patrick.kor[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: September 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dementia
• Depression

Intervention

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
• 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

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic Univeristy	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Five Facets Mindfulness Questionnaire-Short Form	Caregivers' level of mindfulness will be measured as the process indicator by using the Five Facets Mindfulness Questionnaire Short Form. It is a self-report questionnaire measuring the five facets of mindfulness which includes observing, describing, acting with awareness, non-judging of inner and non-reactivity to inner experience (e.g., "I'm good at finding words to describe my feelings"). The total score ranges from 20 to 100 and the higher the score, the higher level of mindfulness.; Comparisons of changes of the five facets mindfulness questionnaire-short form 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))
Primary	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	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))
Secondary	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))
Secondary	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))
Secondary	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))