Clinical trial NCT03789994: Affective Touching on Poststroke Depression
Official title: Family Caregivers Affective Touching for Improving Depressive Symptoms of Community Dwelling Stroke Survivors Through Security Priming
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-stroke Depression
Keywords: Family caregiver
attachment security
affective touch
self-esteem
family harmony
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Research Grants Council, Hong Kong
First posted: 2018-12-31
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of number of depressive symptoms of stroke survivors at 3 months
timeFrame: Change of baseline number of depressive symptoms at 3 months
measure: Change of number of depressive symptoms of stroke survivors at 9 months
timeFrame: Change of baseline number of depressive symptoms at 9 months
Secondary outcomes:
measure: Change of state of attachment security of stroke survivors at 3 and 9 months
timeFrame: Baseline, 3 and 9 months
measure: Change of state self-esteem of stroke survivors at 3 and 9 months
timeFrame: Baseline, 3 and 9 months
measure: Change of perceived family harmony of stroke survivors at 3 and 9 months
timeFrame: Baseline, 3 and 9 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Nethersole School of Nursing, Chinese University of Hong Kong
state: Please Select
Study officials:
References: