Affective Touching on Poststroke Depression

Post-stroke Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03789994
• Other study ID #: CRE 2018.012
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2022
• Source: Chinese University of Hong Kong
• Contact: Ho Yu CHENG, PhD
• Phone: 85239436230
• Email: hycheng[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Post-stroke Depression

Intervention

Behavioral:
• Affective 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.

Other:
• Fine motor exercise
Fine motor exercises that are commonly used for rehabilitation.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Research Grants Council

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of number of depressive symptoms of stroke survivors at 3 months	Number 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 baseline number of depressive symptoms at 3 months
Primary	Change of number of depressive symptoms of stroke survivors at 9 months	Number 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 baseline number of depressive symptoms at 9 months
Secondary	Change of state of attachment security of stroke survivors at 3 and 9 months	State 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.	Baseline, 3 and 9 months
Secondary	Change of state self-esteem of stroke survivors at 3 and 9 months	State 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.	Baseline, 3 and 9 months
Secondary	Change of perceived family harmony of stroke survivors at 3 and 9 months	Perceived 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.	Baseline, 3 and 9 months