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Ecological Momentary Intervention for Stroke Caregivers' Psychological Support

Primary Purpose

Stroke, Caregiver Burnout, Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
iCBT-based EMI
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary family caregiver of stroke patient (modified Barthel Index [mBI] <15; usually represent moderate disability)
  • Able to read and communicate in Chinese
  • Aged ≥18
  • Able to use mobile phone text messaging function
  • PHQ-9 ranged from 5 to 19

Exclusion Criteria:

  • Professional medical personnel and professional carer
  • Has provided care for <1 month prior to recruitment
  • Has diagnosis of psychiatric disease or is currently taking psychotropic drug
  • PHQ-9 ≥ 20 (i.e., severe depressive symptom)
  • Currently participating in any type of psychological intervention (e.g., CBT)

Sites / Locations

  • Hong Kong PHAB AssociationRecruiting
  • Hong Kong Stroke AssociationRecruiting
  • NT West Community Rehabilitation Day CentreRecruiting
  • Queen Mary HospitalRecruiting
  • Southern District Elderly Community Centre
  • The Hong Kong Society for RehabilitationRecruiting
  • Tung Wah HospitalRecruiting
  • United Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.

Receive general mental health information through instant message.

Outcomes

Primary Outcome Measures

Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom

Secondary Outcome Measures

Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms
Stress level (Perceived Stress Scale [PSS-4])
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress
Caregiver's burden (Zarit Burden Interview [ZBI-4])
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden
Caring experience (Positive Aspects of Caregiving [PAC])
An 11-item scale with score ranging from 0 to 44, higher scores indicate more positive appraisal of caregiving experience
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
A 5-item scale with predicted values ranging from -.864 to 1, higher values indicate higher health-related quality of life

Full Information

First Posted
June 15, 2021
Last Updated
July 25, 2022
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04936828
Brief Title
Ecological Momentary Intervention for Stroke Caregivers' Psychological Support
Official Title
Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of 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
The proposed trial aims to evaluate the effectiveness of internet-delivered cognitive behavioural therapy (iCBT) based ecological momentary intervention (EMI) for psychological well-being in stroke family caregivers.
Detailed Description
Many stroke patients require long-term care in the community. In Hong Kong (HK), most stroke caregivers in the community are family members, and many require psychological support for caregiver stress. However, these caregivers have difficulties accessing existing centre-based services due to varying work and care responsibilities, and therefore require alternative support services to meet their unique needs and schedules. Evidence shows that internet-delivered cognitive behavioural therapy (iCBT) is effective in managing psychological distress including depressive symptoms, especially when guided by healthcare professionals. Ecological momentary intervention (EMI) is an innovative and cost-effective intervention 'framework' that utilises mobile messages to deliver personalised psychological interventions. The proposed trial aims to deliver iCBT-based EMI through instant messaging applications (e.g. WhatsApp) to provide personalised and real-time psychological support led by nurses. Screened stroke caregivers with Patient Health Questionnaire-9 (PHQ-9) scores ranging from 5 to 19 (mild to moderately severe depressive symptoms) will be recruited from community centres, rehabilitation centres and outpatient clinics in HK. They will then be individually randomised into the Intervention group (n=128) or Control group (n=128). The Intervention group will receive the iCBT-based EMI for 12 weeks, which includes instant messages sent at the times and frequencies of the participants' choosing, and chat-based psychological support led by nurses to enhance effects of iCBT through real-time counselling and practical advice. The control group will only receive instant messages on general mental health information and reminders to participate in follow-up surveys. The primary outcome is PHQ-9 scores at 24 weeks. Secondary outcomes will include anxiety, perceived stress, caregiver burden, caring experience, spiritual well-being and quality-of-daily-life. We will strictly follow the CONSORT-EHEALTH checklist. A post-trial qualitative study will be conducted to understand the participants' experience of and compliance with the EMI. The intervention will be highly applicable for all caregivers requiring psychological support and will be one step further in meeting the World Health Organization's recommendations in supporting caregivers in the context of global ageing populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Caregiver Burnout, Depressive Symptoms, Psychological Distress, Mobile Phone Use

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Receive general mental health information through instant message.
Intervention Type
Other
Intervention Name(s)
iCBT-based EMI
Intervention Description
Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and nurse-led real-time chat-based support messages, delivered according to participants' preferences.
Primary Outcome Measure Information:
Title
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
Description
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom
Time Frame
24-week
Secondary Outcome Measure Information:
Title
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
Description
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms
Time Frame
24-week
Title
Stress level (Perceived Stress Scale [PSS-4])
Description
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress
Time Frame
24-week
Title
Caregiver's burden (Zarit Burden Interview [ZBI-4])
Description
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden
Time Frame
24-week
Title
Caring experience (Positive Aspects of Caregiving [PAC])
Description
An 11-item scale with score ranging from 0 to 44, higher scores indicate more positive appraisal of caregiving experience
Time Frame
24-week
Title
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
Description
An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being
Time Frame
24-week
Title
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
Description
A 5-item scale with predicted values ranging from -.864 to 1, higher values indicate higher health-related quality of life
Time Frame
24-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary family caregiver of stroke patient (modified Barthel Index [mBI] <15; usually represent moderate disability) Able to read and communicate in Chinese Aged ≥18 Able to use mobile phone text messaging function PHQ-9 ranged from 5 to 19 Exclusion Criteria: Professional medical personnel and professional carer Has provided care for <1 month prior to recruitment Has diagnosis of psychiatric disease or is currently taking psychotropic drug PHQ-9 ≥ 20 (i.e., severe depressive symptom) Currently participating in any type of psychological intervention (e.g., CBT)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Jae LEE
Phone
+85239176971
Email
leejay@hku.hk
Facility Information:
Facility Name
Hong Kong PHAB Association
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Pau
Phone
24268338
Email
garypau@hkphab.org.hk
Facility Name
Hong Kong Stroke Association
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Chui
Phone
23078257
Email
hk_stroke_a@yahoo.com
Facility Name
NT West Community Rehabilitation Day Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So
Phone
24569577
Email
ncrc.sw@naac.org.hk
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Lau
Phone
22554249
Email
gkklau@hku.hk
Facility Name
Southern District Elderly Community Centre
City
Hong Kong
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
The Hong Kong Society for Rehabilitation
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Cheung
Phone
22056336
Email
mike.cheung@rehabsociety.org.hk
Facility Name
Tung Wah Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsz Kin Kwok
Phone
28597500
Email
bigmouth.kwok@gmail.com
Facility Name
United Christian Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mick Yu
Phone
52156783
Email
yuct1@ha.org.hk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ecological Momentary Intervention for Stroke Caregivers' Psychological Support

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