NCT06604481

Brief Summary

The goal of this three-armed, double-blind randomized controlled trial (RCT) is to compare the effectiveness of an online self-help eCoaching intervention designed for caregivers. The main questions it aims to answer are: What is the impact of the online self-help eCoaching intervention on the well-being, depressive symptoms, and self-efficacy of participants? Researchers will compare the results between the intervention groups and the control group to see if participants in the intervention groups have lower distress, burden and higher accuracy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Apr 2025Sep 2026

First Submitted

Initial submission to the registry

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

September 17, 2024

Last Update Submit

June 5, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is a self-report instrument used to assess symptoms of depression.

    3 months

  • Carers Multidimensional Need Assessment Tool

    Carers Multidimensional Need Assessment Tool 22-item. The Carers Multidimensional Need Assessment Tool is a 22-item assessment that evaluates caregivers across 5 key domains of risk:Carers' mental ill health, Caregiving capacity, Lack of support, Carers' health challenges and High care demands.

    3 months

  • Generalised Anxiety Disorder (GAD-7)

    The GAD-7 is a 7-item screening tool used to assess the severity of generalized anxiety disorder.

    3 months

Secondary Outcomes (4)

  • Cantonese short version of the Zarit Burden Interview (CZBI)

    3 months

  • The World Health Organization Quality of Life (WHOQoL-BREF)

    3 months

  • Connor-Davidson Resilience Scale (CD-RISC-25)

    3 months

  • Self-Care Self-Efficacy Scale (SCSES-10)

    3 months

Study Arms (3)

eCoaching Group I

EXPERIMENTAL

Online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills. All content will be covered.

Behavioral: eCoaching for Caregivers of Older Adults

eCoaching Group II

EXPERIMENTAL

Online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills. Content will be covered specified to the carer's specific needs.

Behavioral: eCoaching (need specific) for Caregivers of Older Adults

Control Group

ACTIVE COMPARATOR

Online sessions focused on education about lifestyle and communication.

Behavioral: Control Intervention for Caregivers of Older Adults

Interventions

The experimental group receives an online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills. This program is designed to operate individually on an e-platform. It consists of 6 weekly sessions, each lasting for less than 90 minutes. The content of the sessions focuses on teaching caregivers CBT techniques, lifestyle modifications to improve caregiving experiences, and effective communication strategies. In between each session, participants are assigned home practices to reinforce the skills learned further. All content will be included.

eCoaching Group I

The experimental group receives an online intervention based on Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, lifestyle intervention, and effective communication skills as in eCoaching I. However, eCoaching II will include content specified to carer's specific need.

eCoaching Group II

The control group attends 6 weekly online sessions that primarily provide educational information about lifestyle factors and communication. These sessions aim to enhance the control group's knowledge and understanding of the factors that impact caregiving. Each session in the control group also lasts for 90 minutes. The focus of these activities will be on building practical caregiving skills and promoting overall well-being, rather than targeting any particular psychological or mental health-related factors directly.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being an adult aged 18 or above with a family member aged 60 or above requiring caregiving, providing at least 6 hours of care per week
  • self-identifying as a family caregiver
  • living in Hong Kong
  • able to communicate with the interventionist
  • voluntary participation
  • reporting mild risk need in Carer Need Screening tool

You may not qualify if:

  • having diagnosed Alzheimer's or other dementia
  • experiencing acute health conditions that hinder caregiving support or intervention participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sau Po Center on Ageing HKU

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Vivian Lou, PhD

    Sau Po Center on Ageing, HKU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian Lou, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

April 30, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Data collected in this study will be published and submitted to academic journals to share with other researchers.

Shared Documents
STUDY PROTOCOL
Time Frame
Between 2024 and 2026, the data will become available.
Access Criteria
Upon request from the academic journals.

Locations