Clinical trial NCT05448261: Emotion-centered Problem-solving Intervention for Family Caregivers of Stroke Survivors (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
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Stroke
Keywords: Stroke
family caregivers
emotion-centered problem-solving
psychosocial wellbeing
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research is a sequential mixed-method study that includes a randomized controlled trial and a descriptive qualitative study
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Depressive levels of caregivers
timeFrame: Change of depressive levels from baseline to 3 months and to 9 months
Secondary outcomes:
measure: Problem-solving coping abilities of caregivers
timeFrame: Change of problem-solving coping abilities from baseline to 3 months and to 9 months
measure: Emotion regulation strategies of caregivers
timeFrame: Change of emotion regulation strategies from baseline to 3 months and to 9 months
measure: Caregiving competence of caregivers
timeFrame: Change of caregiving competence from baseline to 3 months and to 9 months
measure: Health-related quality of life of caregivers
timeFrame: Change of health-related quality of life from baseline to 3 months and to 9 months
measure: Physical functioning of stroke survivors
timeFrame: Change of physical functioning from baseline to 3 months and to 9 months
Other outcomes:
measure: Depressive symptoms of stroke survivors
timeFrame: At baseline, 3 months and 9 months
Locations:
city: Hong Kong
country: China
facility: The Nethersole School of Nursing, Chinese University of Hong Kong
state: Please Select
Study officials:
References: