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Emotion-centered Problem-solving Intervention for Family Caregivers of Stroke Survivors (SoLVE) (SoLVE)

Primary Purpose

Depression, Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Emotion-centered problem-solving intervention (EPi)
stroke education
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression focused on measuring Stroke, family caregivers, emotion-centered problem-solving, psychosocial wellbeing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Hong Kong residents, aged 18 years or above;
  • can understand and provide informed consent (Abbreviated Mental Test, Hong Kong version score ≥6];
  • with premorbid depressive symptoms (20-item Center of Epidemiology Studies Depression Scale score ≥841);
  • Chinese family caregivers of stroke survivors who had been diagnosed of ischemic or hemorrhagic stroke within the past 6 months and had residual physical impairment (score of Modified Barthel Index <91);
  • family members who assume the primary responsibility for caring the stroke patient and who are identified by the stroke patients as their primary caregiver;
  • with no history of self-reported/doctor diagnosed psychiatric illness

Exclusion Criteria:

  • Patient-caregiver dyads who are non-Chinese

Sites / Locations

  • The Nethersole School of Nursing, Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Emotion-centered problem-solving intervention (EPi)

Stroke education

Arm Description

The EPi comprises four weekly 60 minutes individual face-to-face session (45 minutes of emotion-centered problem-solving intervention and 15 minutes of stroke education), followed by two bi-weekly telephone follow-ups (30 minutes) and one face-to-face round up session (60 minutes). The content of the stroke education will be based on a developed booklet for local family caregivers (please refer to control group).

The CG will receive basic education on stroke caregiving, as research indicates that basic education is not effective in improving problem-solving coping abilities and depressive symptoms. Four weekly individual stroke education (60 minutes/session) will be conducted by a trained research nurse. It will be based on a developed information booklet for local stroke caregivers. The participants will received three biweekly phone calls for general greetings. Questions relating to stroke caregiving raised by the caregivers will be answered according to the educative content. Any extra information provided will be documented.

Outcomes

Primary Outcome Measures

Depressive levels of caregivers
Measured by using the Chinese version of 20-item Center of Epidemiology Studies Depression Scale

Secondary Outcome Measures

Problem-solving coping abilities of caregivers
Measured by using the Chinese version of Problem Solving Inventory
Emotion regulation strategies of caregivers
Measured by using the Chinese version of the Emotion Regulation Questionnaire
Caregiving competence of caregivers
Measured by using the Chinese version of the Caregiving Competence Scale
Health-related quality of life of caregivers
Measured by using the Chinese version of the Medical Outcome Study 12-item Short Form Health Survey version 2
Physical functioning of stroke survivors
Measured by using the Chinese version of the Modified Barthel Index (MBI)

Full Information

First Posted
July 2, 2022
Last Updated
July 18, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05448261
Brief Title
Emotion-centered Problem-solving Intervention for Family Caregivers of Stroke Survivors (SoLVE)
Acronym
SoLVE
Official Title
FoStering psychosOcial weLlbeing of Family Caregivers of Stroke surVivors Using Emotion-centered, Problem-solving Approach (SoLVE): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2022 (Anticipated)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is one of the leading causes of disability globally. Stroke survivors generally require lifelong support from family caregivers. The abrupt onset of stroke and associated physical and cognitive impairments result in a series of complex and demanding interactions between family caregivers and stroke survivors. More than 40% of stroke caregivers develop depressive symptoms over time. The depression of family caregivers negatively impacts their physical health and caregiving role and directly affects the mental health and recovery of stroke survivors. Thus, effective strategies for stressful caregiving situations are urgently needed. As postulated in the relational/problem solving model of stress, problem-solving coping is a cognitive behavioral process that can enhance caregivers' well-being by changing caregiving situations and/or changing their negative emotional stress responses to stressful situations into positive responses. In view of the influence of negative emotions on the cognitive process of an individual, integrating perspective taking as a cognitive reappraisal strategy into the training of problem-solving coping skills may potentially improve the psychosocial well-being of family caregivers. This mixed method study aims (1) to examine the effects of a emotion-centered problem-solving intervention on the depressive symptoms, problem-solving coping, emotion regulation, caregiving competence, and health-related quality of life of stroke caregivers and on the physical functioning of stroke survivors; (2) to explore the mediating effect of emotion regulation and problem solving coping on caregivers' depressive symptoms, caregiving competence, and health-related quality of life and on stroke survivors' physical functioning; and (3) to understand how intervention influences depressive symptoms from a family caregiver's perspective. A total of 178 family caregivers will be recruited from various non-government organizations and nurse clinics for stroke patients of the Hospital Authority. Participants will be randomly allocated to the intervention group (IG) and control group (CG). Caregivers in the IG will receive an emotion-centered problem-solving intervention adopting a "shared problem, shared action plan" approach, whereas the caregivers in the CG will receive stroke-related education. Outcomes will be measured at baseline, 12 and 36 weeks after study entry. This study makes the first attempt to develop an emotion-centered problem-solving intervention and examine its effectiveness in the context of stroke caregiving. The findings will advance our understanding of emotional regulation and problem-solving coping strategies for reducing the depressive symptoms of stroke caregivers, ultimately providing a culturally sensitive medical-social service direction for the delivery of community-based rehabilitation services to stroke families.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Stroke
Keywords
Stroke, family caregivers, emotion-centered problem-solving, psychosocial wellbeing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This research is a sequential mixed-method study that includes a randomized controlled trial and a descriptive qualitative study
Masking
Outcomes Assessor
Masking Description
Group allocation will be sealed in an opaque envelope and will be given to the participants according to their sequence of study entry, and will be concealed from outcome assessors.
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emotion-centered problem-solving intervention (EPi)
Arm Type
Experimental
Arm Description
The EPi comprises four weekly 60 minutes individual face-to-face session (45 minutes of emotion-centered problem-solving intervention and 15 minutes of stroke education), followed by two bi-weekly telephone follow-ups (30 minutes) and one face-to-face round up session (60 minutes). The content of the stroke education will be based on a developed booklet for local family caregivers (please refer to control group).
Arm Title
Stroke education
Arm Type
Sham Comparator
Arm Description
The CG will receive basic education on stroke caregiving, as research indicates that basic education is not effective in improving problem-solving coping abilities and depressive symptoms. Four weekly individual stroke education (60 minutes/session) will be conducted by a trained research nurse. It will be based on a developed information booklet for local stroke caregivers. The participants will received three biweekly phone calls for general greetings. Questions relating to stroke caregiving raised by the caregivers will be answered according to the educative content. Any extra information provided will be documented.
Intervention Type
Behavioral
Intervention Name(s)
Emotion-centered problem-solving intervention (EPi)
Intervention Description
The EPi is built upon the model of relational/problem-solving model of stress and is aimed at supporting caregivers in (1) revisiting stressful caregiving and associated problem from a psychological distanced perspective; (2) adopting problem orientation toward one's experience in the present moments with curiosity, openness and acceptance; and (3) applying the problem-solving skills learned for the enhancement of their psychosocial wellbeing in the stressful caregiving context. To reduce the incongruence between caregivers and stroke survivors in problem-solving, we will adopt a "shared problem, shared action plan" approach for the family caregivers and stroke survivors.
Intervention Type
Other
Intervention Name(s)
stroke education
Intervention Description
Information is related to stroke and recurrent stroke and strategies for assisting stroke survivors in day-to-day activities.
Primary Outcome Measure Information:
Title
Depressive levels of caregivers
Description
Measured by using the Chinese version of 20-item Center of Epidemiology Studies Depression Scale
Time Frame
Change of depressive levels from baseline to 3 months and to 9 months
Secondary Outcome Measure Information:
Title
Problem-solving coping abilities of caregivers
Description
Measured by using the Chinese version of Problem Solving Inventory
Time Frame
Change of problem-solving coping abilities from baseline to 3 months and to 9 months
Title
Emotion regulation strategies of caregivers
Description
Measured by using the Chinese version of the Emotion Regulation Questionnaire
Time Frame
Change of emotion regulation strategies from baseline to 3 months and to 9 months
Title
Caregiving competence of caregivers
Description
Measured by using the Chinese version of the Caregiving Competence Scale
Time Frame
Change of caregiving competence from baseline to 3 months and to 9 months
Title
Health-related quality of life of caregivers
Description
Measured by using the Chinese version of the Medical Outcome Study 12-item Short Form Health Survey version 2
Time Frame
Change of health-related quality of life from baseline to 3 months and to 9 months
Title
Physical functioning of stroke survivors
Description
Measured by using the Chinese version of the Modified Barthel Index (MBI)
Time Frame
Change of physical functioning from baseline to 3 months and to 9 months
Other Pre-specified Outcome Measures:
Title
Depressive symptoms of stroke survivors
Description
Measured by using the Chinese version of 20-item Center of Epidemiology Studies Depression Scale
Time Frame
At baseline, 3 months and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hong Kong residents, aged 18 years or above; can understand and provide informed consent (Abbreviated Mental Test, Hong Kong version score ≥6]; with premorbid depressive symptoms (20-item Center of Epidemiology Studies Depression Scale score ≥841); Chinese family caregivers of stroke survivors who had been diagnosed of ischemic or hemorrhagic stroke within the past 6 months and had residual physical impairment (score of Modified Barthel Index <91); family members who assume the primary responsibility for caring the stroke patient and who are identified by the stroke patients as their primary caregiver; with no history of self-reported/doctor diagnosed psychiatric illness Exclusion Criteria: Patient-caregiver dyads who are non-Chinese
Facility Information:
Facility Name
The Nethersole School of Nursing, Chinese University of Hong Kong
City
Hong Kong
State/Province
Please Select
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotion-centered Problem-solving Intervention for Family Caregivers of Stroke Survivors (SoLVE)

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