Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers (EPI)

July 10, 2024 updated by: The University of Hong Kong

Instant Message-delivered Early Psychological Intervention in Stroke Family Caregivers: a Mixed-method Study

Psychological distress including depression and anxiety is a major component of caregiver stress, and its negative impact on caregivers' health and well-being has been established in the literature. A recent meta-analysis reported the prevalence of depression and anxiety in stroke caregivers as 40.2% and 21.4% respectively.

An evidence profile report by the World Health Organization(WHO) has emphasised that psychological support is crucial in helping caregivers in the community to continue caring for individuals with long-term disabilities, such as stroke patients. Therefore, early psychological intervention (EPI) is crucial to improve the management and prognosis of an individual who are facing stressful events like caregiving.

The main aim of this study is to prevent or alleviate the significant psychological consequences in carers resulting from stroke events in family members. Internet-delivered cognitive-behavioural therapy (iCBT) is delivered as an ecological momentary intervention (EMI) to support the clients to engage in cognitive reframing and empower them with proper knowledge, skills and attitudes to make behavioural changes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

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: +852 3917 6971
  • Email: leejay@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Princess Margaret Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Elizabeth Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • Kwong Wah Hospital
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • United Christian Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary family caregiver of first-ever stroke patient who has <15 modified Barthel Index(mBI) scores (moderate disability);
  • Caregiver of a stroke patient who has a hospital inpatient stay of ≥6 days and ≤21days;
  • Aged ≥18;
  • Able to read and communicate in Chinese (Cantonese or Putonghua);
  • Able to use mobile phone instant messaging function; and
  • PHQ-9 (depressive symptom) score ranging from 5 to 19 (note. mild: 5-9, moderate: 10-14, moderately severe: 15-19 and severe: 20-27)

Exclusion Criteria:

  • Caregiver of stroke patient who is admitted to intensive care unit;
  • Professional medical personnel and/or professional carer;
  • Diagnosis of psychiatric disease before stroke event or currently taking psychotropic drug including antidepressants;
  • PHQ-9≥20 (we shall provide information on mental health services; if needed, we shall make the appropriate referrals); and
  • Currently participating in any type of psychological intervention.

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.
Behavioral: 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
Loneliness level (UCLA Loneliness Scale [ULS-8])
Time Frame: 24-week
The total score (8 items) ranges from 8 to 32 points, with higher scores suggesting a higher degree of loneliness
24-week
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: 24-week
The total score (7 items) ranges from 7 to 49 points, with higher scores suggesting a higher degree of psychological inflexibility and experiential avoidance
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)

July 24, 2023

Primary Completion (Estimated)

July 24, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI2023

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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