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

Stroke Clinical Trial

— SoLVE  

Official title:

FoStering psychosOcial weLlbeing of Family Caregivers of Stroke surVivors Using Emotion-centered, Problem-solving Approach (SoLVE): A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05448261
• Other study ID #: 14610421
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Stroke

Intervention

Behavioral:
• Emotion-centered problem-solving intervention (EPi)
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.

Other:
• stroke education
Information is related to stroke and recurrent stroke and strategies for assisting stroke survivors in day-to-day activities.

Locations

Country	Name	City	State
China	The Nethersole School of Nursing, Chinese University of Hong Kong	Hong Kong	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depressive symptoms of stroke survivors	Measured by using the Chinese version of 20-item Center of Epidemiology Studies Depression Scale	At baseline, 3 months and 9 months
Primary	Depressive levels of caregivers	Measured by using the Chinese version of 20-item Center of Epidemiology Studies Depression Scale	Change of depressive levels from baseline to 3 months and to 9 months
Secondary	Problem-solving coping abilities of caregivers	Measured by using the Chinese version of Problem Solving Inventory	Change of problem-solving coping abilities from baseline to 3 months and to 9 months
Secondary	Emotion regulation strategies of caregivers	Measured by using the Chinese version of the Emotion Regulation Questionnaire	Change of emotion regulation strategies from baseline to 3 months and to 9 months
Secondary	Caregiving competence of caregivers	Measured by using the Chinese version of the Caregiving Competence Scale	Change of caregiving competence from baseline to 3 months and to 9 months
Secondary	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	Change of health-related quality of life from baseline to 3 months and to 9 months
Secondary	Physical functioning of stroke survivors	Measured by using the Chinese version of the Modified Barthel Index (MBI)	Change of physical functioning from baseline to 3 months and to 9 months