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Affective Touching on Poststroke Depression

Family Caregivers Affective Touching for Improving Depressive Symptoms of Community Dwelling Stroke Survivors Through Security Priming

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03789994
Enrollment
184
Registered
2018-12-31
Start date
2019-12-01
Completion date
2022-06-30
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke Depression

Keywords

Family caregiver, attachment security, affective touch, self-esteem, family harmony

Brief summary

This mixed-method study includes a randomised controlled trial and an exploratory qualitative study, and aims to examine the effects of caregiver-delivered affective touch on depressive symptoms, state of attachment security, self-esteem, and perceived family harmony among stroke survivors, and to explore the mediating effect of attachment security and how an intervention may affect depressive symptoms from stroke survivor's perspective. A total of 184 survivor-caregiver dyads will be recruited from various non-governmental organisations. The dyads will be randomly allocated to intervention (IG) and control (CG) groups, stratified by the survivor's attachment style. IG caregivers will be taught to deliver a 15-minute affective touch intervention to stroke survivors. To address the attention effect, CG caregivers will be asked to sit with the survivors during a 15-minute fine motor coordination exercise. Both activities, affective touching and fine motor exercise, will be performed for 12 weeks (3 times/week), and the outcomes mentioned earlier will be measured at baseline, 12 and 36 weeks after study entry.

Interventions

BEHAVIORALAffective touch

The affective touch comprises of two elements, namely the signal of care, love and acceptance, and stimulation of CT afferent of the skin. Caregivers will be trained to perform light stroking on stroke survivor's forearm while reviewing happy events with the use of photos.

OTHERFine motor exercise

Fine motor exercises that are commonly used for rehabilitation.

Sponsors

Research Grants Council, Hong Kong
CollaboratorOTHER
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Stroke survivor-caregiver dyads * Hong Kong residents, aged 18 years or above, * able to understand and give informed consent \[Abbreviated Mental Test (Hong Kong version) score ≥6\]. 2. Stroke survivors * within the first three months of being diagnosed with first-onset acute ischemic/haemorrhagic stroke, * able to comprehend verbal instructions, * with premorbid depressive symptoms \[20-item Centre of Epidemiology Studies Depression Scale score ≥8\]. 3. Family caregivers * family members who assume the primary responsibility for caring for a stroke survivor and who are identified by the survivors as their primary caregivers, * live with the survivors and provide care ≥4 hours/day, * have no history of self-reported or medical diagnosis of psychiatric illness, * are able to learn and willing to provide the intervention.

Exclusion criteria

* Stroke survivor-caregiver dyads who are not Chinese

Design outcomes

Primary

MeasureTime frameDescription
Change of number of depressive symptoms of stroke survivors at 3 monthsChange of baseline number of depressive symptoms at 3 monthsNumber of depressive symptoms of stroke survivors will be measured by the Chinese version of the 20-item Centre of Epidemiology Studies Depression Scale, which rates participant's mood on a four-point Likert scale (0 = rarely or none of the time, 3 = almost or all of the time), higher score indicating more severe symptoms.
Change of number of depressive symptoms of stroke survivors at 9 monthsChange of baseline number of depressive symptoms at 9 monthsNumber of depressive symptoms of stroke survivors will be measured by the Chinese version of the 20-item Centre of Epidemiology Studies Depression Scale, which rates participant's mood on a four-point Likert scale (0 = rarely or none of the time, 3 = almost or all of the time), higher score indicating more severe symptoms.

Secondary

MeasureTime frameDescription
Change of state of attachment security of stroke survivors at 3 and 9 monthsBaseline, 3 and 9 monthsState of attachment security of stroke survivors will be measured by the Chinese version of State Adult Attachment Measure (SAAM). The SAAM comprises 21 items and participants will be asked to use a seven-point Likert scale (1 = disagree strongly; 7 = agree strongly) to rate the extent to which they agree with the items assessing state of attachment security, state of attachment avoidance, and state of attachment anxiety.
Change of state self-esteem of stroke survivors at 3 and 9 monthsBaseline, 3 and 9 monthsState self-esteem of stroke survivors will be measured by the Chinese version of the State Self-esteem Scale (SSES). The SSES comprised 20 items and participants will indicate whether each item is true of themselves at that moment, using a five-point Likert scale (1 = not at all, 5 = extremely). Higher scores indicate greater state self-esteem.
Change of perceived family harmony of stroke survivors at 3 and 9 monthsBaseline, 3 and 9 monthsPerceived family harmony of stroke survivor will be measured by the five-item Chinese version of the Family Harmony Scale (FHS). Participants will indicate whether they agree with the items describing family harmony on a five-point Likert-scale (1 = strongly agree, 5 = strongly disagree), lower scores indicating greater harmony.

Countries

China

Contacts

Primary ContactHo Yu CHENG, PhD
hycheng@cuhk.edu.hk85239436230

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026