<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03789994</url>
  </required_header>
  <id_info>
    <org_study_id>CRE 2018.012</org_study_id>
    <nct_id>NCT03789994</nct_id>
  </id_info>
  <brief_title>Affective Touching on Poststroke Depression</brief_title>
  <official_title>Family Caregivers Affective Touching for Improving Depressive Symptoms of Community Dwelling Stroke Survivors Through Security Priming</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Research Grants Council, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This mixed-method study includes a randomised controlled trial and an exploratory qualitative&#xD;
      study, and aims to examine the effects of caregiver-delivered affective touch on depressive&#xD;
      symptoms, state of attachment security, self-esteem, and perceived family harmony among&#xD;
      stroke survivors, and to explore the mediating effect of attachment security and how an&#xD;
      intervention may affect depressive symptoms from stroke survivor's perspective. A total of&#xD;
      184 survivor-caregiver dyads will be recruited from various non-governmental organisations.&#xD;
      The dyads will be randomly allocated to intervention (IG) and control (CG) groups, stratified&#xD;
      by the survivor's attachment style. IG caregivers will be taught to deliver a 15-minute&#xD;
      affective touch intervention to stroke survivors. To address the attention effect, CG&#xD;
      caregivers will be asked to sit with the survivors during a 15-minute fine motor coordination&#xD;
      exercise. Both activities, affective touching and fine motor exercise, will be performed for&#xD;
      12 weeks (3 times/week), and the outcomes mentioned earlier will be measured at baseline, 12&#xD;
      and 36 weeks after study entry.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of number of depressive symptoms of stroke survivors at 3 months</measure>
    <time_frame>Change of baseline number of depressive symptoms at 3 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of number of depressive symptoms of stroke survivors at 9 months</measure>
    <time_frame>Change of baseline number of depressive symptoms at 9 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of state of attachment security of stroke survivors at 3 and 9 months</measure>
    <time_frame>Baseline, 3 and 9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of state self-esteem of stroke survivors at 3 and 9 months</measure>
    <time_frame>Baseline, 3 and 9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of perceived family harmony of stroke survivors at 3 and 9 months</measure>
    <time_frame>Baseline, 3 and 9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">184</enrollment>
  <condition>Post-stroke Depression</condition>
  <arm_group>
    <arm_group_label>Affective touch group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fine motor group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Affective touch</intervention_name>
    <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.</description>
    <arm_group_label>Affective touch group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fine motor exercise</intervention_name>
    <description>Fine motor exercises that are commonly used for rehabilitation.</description>
    <arm_group_label>Fine motor group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Stroke survivor-caregiver dyads&#xD;
&#xD;
               -  Hong Kong residents, aged 18 years or above,&#xD;
&#xD;
               -  able to understand and give informed consent [Abbreviated Mental Test (Hong Kong&#xD;
                  version) score ≥6].&#xD;
&#xD;
          2. Stroke survivors&#xD;
&#xD;
               -  within the first three months of being diagnosed with first-onset acute&#xD;
                  ischemic/haemorrhagic stroke,&#xD;
&#xD;
               -  able to comprehend verbal instructions,&#xD;
&#xD;
               -  with premorbid depressive symptoms [20-item Centre of Epidemiology Studies&#xD;
                  Depression Scale score ≥8].&#xD;
&#xD;
          3. Family caregivers&#xD;
&#xD;
               -  family members who assume the primary responsibility for caring for a stroke&#xD;
                  survivor and who are identified by the survivors as their primary caregivers,&#xD;
&#xD;
               -  live with the survivors and provide care ≥4 hours/day,&#xD;
&#xD;
               -  have no history of self-reported or medical diagnosis of psychiatric illness,&#xD;
&#xD;
               -  are able to learn and willing to provide the intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stroke survivor-caregiver dyads who are not Chinese&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ho Yu CHENG, PhD</last_name>
    <phone>85239436230</phone>
    <email>hycheng@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Nethersole School of Nursing, Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Please Select</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ho Yu CHENG, PhD, RN</last_name>
      <phone>+852 39436230</phone>
      <email>hycheng@cuhk.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Ho Yu CHENG</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Family caregiver</keyword>
  <keyword>attachment security</keyword>
  <keyword>affective touch</keyword>
  <keyword>self-esteem</keyword>
  <keyword>family harmony</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03789994
org study id: CRE 2018.012
nct id: NCT03789994
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change of number of depressive symptoms of stroke survivors at 3 months
time frame: Change of baseline number of depressive symptoms 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.
measure: Change of number of depressive symptoms of stroke survivors at 9 months
time frame: Change of baseline number of depressive symptoms 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.
measure: Change of state of attachment security of stroke survivors at 3 and 9 months
time frame: Baseline, 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.
measure: Change of state self-esteem of stroke survivors at 3 and 9 months
time frame: Baseline, 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.
measure: Change of perceived family harmony of stroke survivors at 3 and 9 months
time frame: Baseline, 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.
arm group label: Affective touch group
arm group type: Experimental
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 group label: Fine motor group
arm group type: Other
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: Affective touch
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.
arm group label: Affective touch group
intervention type: Other
intervention name: Fine motor exercise
description: Fine motor exercises that are commonly used for rehabilitation.
arm group label: Fine motor group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ho Yu CHENG, PhD
phone: 85239436230
email: hycheng@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Ho Yu CHENG
investigator title: Assistant professor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No