NCT06409455

Brief Summary

The goal of this study is to learn if a new online training program is helpful to dementia family caregivers. This online program is fully computerized and supports 24/7 access from any location. The main questions it aims to answer are:

  • Does the training program improves the participants' well-being and sense of positive meaning?
  • If the program is found to be helpful, does it work through enhancing caregivers' self-belief or getting them to practice positive interpretation of caregiving challenges? To answer these questions, researchers will compare the online program to a waitlist control. Participants will:
  • Use the intervention (requiring internet access) in a self-guided manner
  • Respond to brief questionnaires at the beginning, and 1, 2 and 3 months afterwards

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

December 19, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

May 7, 2024

Last Update Submit

September 29, 2025

Conditions

Keywords

Family caregiving

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    Patient Health Questionnaire-9; possible scores 0-27, higher = more depressed

    baseline, 1 month, 2 months, 3 months

Secondary Outcomes (3)

  • Anxiety symptoms

    baseline, 1 month, 2 months, 3 months

  • Caregiver burden

    baseline, 1 month, 2 months, 3 months

  • Positive aspects of caregiving

    baseline, 1 month, 2 months, 3 months

Other Outcomes (2)

  • Caregiving self-efficacy

    3 weeks

  • Positive reappraisal coping

    3 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Caregiver training

Behavioral: Positive Dementia Caregiving in 30 Days

Waitlist control

OTHER

Waitlist control

Behavioral: Positive Dementia Caregiving in 30 Days

Interventions

Based on an evidence-based face-to-face Benefit-Finding Intervention, a computer-delivered web-based program supporting 24/7 access without location restriction, is developed. It is a psychoeducation program with an emphasis on strengthening caregivers' coping capacity through skills training and developing a positive way of looking at caregiving challenges. The program consists of reading materials, illustrated texts, caregivers' testimonies, a chatbot, and several interactive apps to facilitate self-learning at the caregiver's own pace.

Also known as: Benefit-finding Intervention (Online Version)
InterventionWaitlist control

Eligibility Criteria

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

You may qualify if:

  • Having been a dementia caregiver for 3 or more months
  • Providing 10 or more hours of care per week
  • Scoring 5 or above on the Patient Health Questionnaire-9
  • Passing a simple reading comprehension test

You may not qualify if:

  • Caregiver having participated in any training/therapeutic program on dementia care in the past year
  • Care-recipient residing in an institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

  • Cheng ST, Chan WC, Lam LCW. Long-Term Outcomes of the Benefit-Finding Group Intervention for Alzheimer Family Caregivers: A Cluster-Randomized Double-Blind Controlled Trial. Am J Geriatr Psychiatry. 2019 Sep;27(9):984-994. doi: 10.1016/j.jagp.2019.03.013. Epub 2019 Mar 26.

    PMID: 31076215BACKGROUND
  • Cheng ST, Mak EPM, Kwok T, Fung H, Lam LCW. Benefit-Finding Intervention Delivered Individually to Alzheimer Family Caregivers: Longer-Term Outcomes of a Randomized Double-Blind Controlled Trial. J Gerontol B Psychol Sci Soc Sci. 2020 Oct 16;75(9):1884-1893. doi: 10.1093/geronb/gbz118.

    PMID: 31556447BACKGROUND

Study Officials

  • Sheung-Tak Cheng, PhD

    The Education University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Assessor bias is eliminated by having the assessment instruments administered by the computer in an automated manner, without human involvement.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized parallel group (treatment vs. waitlist control) design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor of Psychology and Gerontology

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

December 19, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Materials will be deposited onto a credible repository.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After study completion
Access Criteria
Open access

Locations