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Trial record 43 of 2663 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Affective Touching on Poststroke Depression

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ClinicalTrials.gov Identifier: NCT03789994
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : January 1, 2019
Sponsor:
Collaborator:
Research Grants Council
Information provided by (Responsible Party):
Ho Yu CHENG, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Post-stroke Depression Behavioral: Affective touch Other: Fine motor exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Family Caregivers Affective Touching for Improving Depressive Symptoms of Community Dwelling Stroke Survivors Through Security Priming
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Affective touch group

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.

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.

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




Primary Outcome Measures :
  1. Change of number of depressive symptoms of stroke survivors at 3 months [ Time Frame: Change of baseline number of depressive symptoms 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.

  2. Change of number of depressive symptoms of stroke survivors at 6 months [ Time Frame: Change of baseline number of depressive symptoms at 6 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 :
  1. Change of state of attachment security of stroke survivors at 3 and 6 months [ Time Frame: Baseline, 3 and 6 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.

  2. Change of state self-esteem of stroke survivors at 3 and 6 months [ Time Frame: Baseline, 3 and 6 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.

  3. Change of perceived family harmony of stroke survivors at 3 and 6 months [ Time Frame: Baseline, 3 and 6 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789994


Contacts
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Contact: Ho Yu CHENG, PhD 85239436230 hycheng@cuhk.edu.hk

Locations
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China, Please Select
The Nethersole School of Nursing, Chinese University of Hong Kong Not yet recruiting
Hong Kong SAR, Please Select, China
Contact: Ho Yu CHENG, PhD, RN    +852 39436230    hycheng@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Research Grants Council

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Responsible Party: Ho Yu CHENG, Assistant professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03789994     History of Changes
Other Study ID Numbers: CRE 2018.012
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ho Yu CHENG, Chinese University of Hong Kong:
Family caregiver
attachment security
affective touch
self-esteem
family harmony

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mood Disorders
Mental Disorders