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Clinical Trials/NCT06409455
NCT06409455
Completed
Phase 2

Positive Dementia Caregiving in 30 Days: Randomized Controlled Trial of a Self-guided Automated Online Training Program

Education University of Hong Kong1 site in 1 country274 target enrollmentDecember 19, 2024

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Caregiver Stress Syndrome
Sponsor
Education University of Hong Kong
Enrollment
274
Locations
1
Primary Endpoint
Depressive symptoms
Status
Completed
Last Updated
7 months ago

Overview

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

Detailed Description

The Benefit-Finding Intervention is a type of caregiver intervention called psychoeducation with psychotherapeutic components. It combines standard topics of psychoeducation (e.g., training of care skills and stress management) with training on thinking style. As implied by the title 'benefit-finding', the training style in focus is the inclination to think alternatively and positively about challenging caregiving situations. In two clinical trials, the Benefit-Finding Intervention was compared with didactic psychoeducational programs but without thought training. This comparison allowed researchers to see if the addition of the benefit-finding component produced improvements over the above those achieved by standard psychoeducation. Results supported the superiority of the Benefit-Finding Intervention, with significantly greater reductions of depression and burden up to 10 months after the termination of the intervention. A face-to-face intervention is nonetheless labor intensive. It may also cause inconvenience to caregivers who have to find blocks of time to attend the intervention, while making sure the care-recipient is being attended to. Having to travel to receive help is another challenge, especially for rural populations and older caregivers. The limitation of the face-to-face format was further exposed during the pandemic when such meetings were simply impossible. To address these issues, the original Benefit-Finding Intervention has been adapted for computer-automated delivery on a web platform, which is accessible anytime anywhere. The online intervention is not meant to replace traditional manned intervention, but as an alternative service for those who, for various reasons, cannot benefit from traditional interventions or who prefer the flexible, self-guided and self-paced approach offered by this intervention.

Registry
clinicaltrials.gov
Start Date
December 19, 2024
End Date
September 30, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Education University of Hong Kong
Responsible Party
Principal Investigator
Principal Investigator

Sheung-Tak Cheng

Chair Professor of Psychology and Gerontology

Education University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Depressive symptoms

Time Frame: baseline, 1 month, 2 months, 3 months

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

Secondary Outcomes

  • Positive aspects of caregiving(baseline, 1 month, 2 months, 3 months)
  • Anxiety symptoms(baseline, 1 month, 2 months, 3 months)
  • Caregiver burden(baseline, 1 month, 2 months, 3 months)

Study Sites (1)

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