Ecological Momentary Intervention for Stroke Caregivers' Psychological Support

July 25, 2022 updated by: The University of Hong Kong

Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jung Jae LEE
  • Phone Number: +85239176971
  • Email: leejay@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong PHAB Association
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong Stroke Association
        • Contact:
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • United Christian Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • NT West Community Rehabilitation Day Centre
        • Contact:
      • Hong Kong, Hong Kong
        • Withdrawn
        • Southern District Elderly Community Centre
      • Hong Kong, Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Receive iCBT based EMI with message content, delivery frequency and timing personalised to participants' preferences.
Other: iCBT-based EMI
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.
No Intervention: Control group
Receive general mental health information through instant message.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms (Patient Health Questionnaire-9 [PHQ-9])
Time Frame: 24-week
A 9-item scale with score ranging from 0 to 27, higher scores indicate higher severity of depressive symptom
24-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7])
Time Frame: 24-week
A 7-item scale with score ranging from 0 to 21, higher scores indicate higher severity of anxiety symptoms
24-week
Stress level (Perceived Stress Scale [PSS-4])
Time Frame: 24-week
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of stress
24-week
Spiritual well-being (Sub-scale of Spirituality Scale for Chinese Elders [SSCE])
Time Frame: 24-week
An 8-item scale with score ranging from 0 to 32, higher scores indicate better spiritual well-being
24-week
Caregiver's burden (Zarit Burden Interview [ZBI-4])
Time Frame: 24-week
A 4-item scale with score ranging from 0 to 16, higher scores indicate higher severity of caregiving burden
24-week
Caring experience (Positive Aspects of Caregiving [PAC])
Time Frame: 24-week
An 11-item scale with score ranging from 0 to 44, higher scores indicate more positive appraisal of caregiving experience
24-week
Quality of life (EuroQol 5-dimension 5-level questionnaire [EQ-5D-5L])
Time Frame: 24-week
A 5-item scale with predicted values ranging from -.864 to 1, higher values indicate higher health-related quality of life
24-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17617620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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