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Affective Touching on Poststroke Depression

Primary Purpose

Post-stroke Depression

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Affective touch
Fine motor exercise
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post-stroke Depression focused on measuring Family caregiver, attachment security, affective touch, self-esteem, family harmony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Nethersole School of Nursing, Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Affective touch group

Fine motor group

Arm Description

Survivors in the intervention group will receive a total of 36 sessions of a 15-minute affective touch intervention performed by their family caregivers in their homes. Sessions will be scheduled for every alternate weekday (three times a week) for 12 weeks. A trained research nurse (RN) will conduct three 30-minute caregiver training sessions to support the caregivers in delivering the affective touch. To put caregivers in a more relaxed mood for delivering the intervention, the RN will work with them to identify a time that they feel less burdensome, and teach them to perform deep breathing for relaxation before the affective touching begins. Also, the survivor-caregiver dyad will be asked to sit in a comfortable position and switch off television or radio during the intervention.

To address the additional attention given by caregivers during affective touch, the control group will be asked to sit beside the survivors when they go through the fine motor exercises which are commonly used for rehabilitation. Caregivers will be instructed to provide only necessary help in preparing the equipment, and to avoid touching or talking to the survivors during the 15-minute exercise session. Two such sessions will be arranged for survivors to master the skills needed, and for caregivers to practise the required level of interaction during the exercise training. Participants will be instructed to do the exercise three times a week (every alternate weekday) over 12 weeks.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
December 26, 2018
Last Updated
May 30, 2022
Sponsor
Chinese University of Hong Kong
Collaborators
Research Grants Council, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03789994
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Research Grants Council, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression
Keywords
Family caregiver, attachment security, affective touch, self-esteem, family harmony

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Affective touch group
Arm Type
Experimental
Arm Description
Survivors in the intervention group will receive a total of 36 sessions of a 15-minute affective touch intervention performed by their family caregivers in their homes. Sessions will be scheduled for every alternate weekday (three times a week) for 12 weeks. A trained research nurse (RN) will conduct three 30-minute caregiver training sessions to support the caregivers in delivering the affective touch. To put caregivers in a more relaxed mood for delivering the intervention, the RN will work with them to identify a time that they feel less burdensome, and teach them to perform deep breathing for relaxation before the affective touching begins. Also, the survivor-caregiver dyad will be asked to sit in a comfortable position and switch off television or radio during the intervention.
Arm Title
Fine motor group
Arm Type
Other
Arm Description
To address the additional attention given by caregivers during affective touch, the control group will be asked to sit beside the survivors when they go through the fine motor exercises which are commonly used for rehabilitation. Caregivers will be instructed to provide only necessary help in preparing the equipment, and to avoid touching or talking to the survivors during the 15-minute exercise session. Two such sessions will be arranged for survivors to master the skills needed, and for caregivers to practise the required level of interaction during the exercise training. Participants will be instructed to do the exercise three times a week (every alternate weekday) over 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Affective touch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fine motor exercise
Intervention Description
Fine motor exercises that are commonly used for rehabilitation.
Primary Outcome Measure Information:
Title
Change of number of depressive symptoms of stroke survivors at 3 months
Description
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.
Time Frame
Change of baseline number of depressive symptoms at 3 months
Title
Change of number of depressive symptoms of stroke survivors at 9 months
Description
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.
Time Frame
Change of baseline number of depressive symptoms at 9 months
Secondary Outcome Measure Information:
Title
Change of state of attachment security of stroke survivors at 3 and 9 months
Description
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.
Time Frame
Baseline, 3 and 9 months
Title
Change of state self-esteem of stroke survivors at 3 and 9 months
Description
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.
Time Frame
Baseline, 3 and 9 months
Title
Change of perceived family harmony of stroke survivors at 3 and 9 months
Description
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.
Time Frame
Baseline, 3 and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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]. 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]. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Yu CHENG, PhD
Phone
85239436230
Email
hycheng@cuhk.edu.hk
Facility Information:
Facility Name
The Nethersole School of Nursing, Chinese University of Hong Kong
City
Hong Kong
State/Province
Please Select
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Yu CHENG, PhD, RN
Phone
+852 39436230
Email
hycheng@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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Affective Touching on Poststroke Depression

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