DepressionSoLVENCT05448261
Emotion-centered Problem-solving Intervention for Family Caregivers of Stroke Survivors (SoLVE)
A study testing Emotion-centered problem-solving intervention (EPi) and stroke education in people with Depression and Stroke, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Stroke
- What is being tested?
- Emotion-centered problem-solving intervention (EPi) and stroke education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient-caregiver dyads who are non-Chinese
Trial locations and contacts
1 site in 1 country.
China1 site
The Nethersole School of Nursing, Chinese University of Hong Kong
Hong Kong, Please Select
About this study
Official title: FoStering psychosOcial weLlbeing of Family Caregivers of Stroke surVivors Using Emotion-centered, Problem-solving Approach (SoLVE): A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Depression, Stroke
- Being tested
- Emotion-centered problem-solving intervention (EPi), stroke education
- Keywords
- Stroke, family caregivers, emotion-centered problem-solving, psychosocial wellbeing
- Medical subject headings
- Depression, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-centered problem-solving intervention (EPi)Behavioural
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.
stroke educationOther
Information is related to stroke and recurrent stroke and strategies for assisting stroke survivors in day-to-day activities.
| Study group | Role | What they receive |
|---|---|---|
| Emotion-centered problem-solving intervention (EPi) | Experimental | 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). Receives: Behavioral: Emotion-centered problem-solving intervention (EPi) |
| Stroke education | Sham comparator | 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. Receives: Other: stroke education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive levels of caregivers
Measured by using the Chinese version of 20-item Center of Epidemiology Studies Depression Scale
Measured: Change of depressive levels from baseline to 3 months and to 9 months
Secondary outcomes (5)
Problem-solving coping abilities of caregivers
Measured by using the Chinese version of Problem Solving Inventory
Measured: Change of problem-solving coping abilities from baseline to 3 months and to 9 months
Emotion regulation strategies of caregivers
Measured by using the Chinese version of the Emotion Regulation Questionnaire
Measured: Change of emotion regulation strategies from baseline to 3 months and to 9 months
Caregiving competence of caregivers
Measured by using the Chinese version of the Caregiving Competence Scale
Measured: Change of caregiving competence from baseline to 3 months and to 9 months
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
Measured: Change of health-related quality of life from baseline to 3 months and to 9 months
Physical functioning of stroke survivors
Measured by using the Chinese version of the Modified Barthel Index (MBI)
Measured: Change of physical functioning from baseline to 3 months and to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is a sequential mixed-method study that includes a randomized controlled trial and a descriptive qualitative study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yu CHENG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448261
- Sponsor's protocol ID
- 14610421
- Acronym
- SoLVE
- Status last verified
- Jul 2022
- First submitted
- 2 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FoStering psychosOcial weLlbeing of Family Caregivers of Stroke surVivors Using Emotion-centered, Problem-solving Approach (SoLVE): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05448261
- Acronym / sponsor ID
- SoLVE / 14610421
- Conditions
- Depression, Stroke
- Keywords
- Stroke, family caregivers, emotion-centered problem-solving, psychosocial wellbeing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This research is a sequential mixed-method study that includes a randomized controlled trial and a descriptive qualitative study
| Arm | Type | Receives |
|---|---|---|
| Emotion-centered problem-solving intervention (EPi) | Experimental | Behavioral: Emotion-centered problem-solving intervention (EPi)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). |
| Stroke education | Sham comparator | Other: stroke educationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Patient-caregiver dyads who are non-Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Emotion-centered problem-solving intervention (EPi) |
| stroke educationInformation is related to stroke and recurrent stroke and strategies for assisting stroke survivors in day-to-day activities. | Other | Stroke education |
Primary outcome
Depressive levels of caregivers
Time frame: Change of depressive levels from baseline to 3 months and to 9 months
Measured by using the Chinese version of 20-item Center of Epidemiology Studies Depression Scale
5 secondary outcomes
Problem-solving coping abilities of caregivers
Time frame: Change of problem-solving coping abilities from baseline to 3 months and to 9 months
Emotion regulation strategies of caregivers
Time frame: Change of emotion regulation strategies from baseline to 3 months and to 9 months
Caregiving competence of caregivers
Time frame: Change of caregiving competence from baseline to 3 months and to 9 months
Health-related quality of life of caregivers
Time frame: Change of health-related quality of life from baseline to 3 months and to 9 months
Physical functioning of stroke survivors
Time frame: Change of physical functioning from baseline to 3 months and to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion-centered problem-solving intervention (EPi) and stroke education in people with Depression and Stroke, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive levels of caregivers (time frame: Change of depressive levels from baseline to 3 months and to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.