Clinical trial NCT06409455: Positive Dementia Caregiving: Clinical Trial of an Online Training Program
Official title: Positive Dementia Caregiving in 30 Days: Randomized Controlled Trial of a Self-guided Automated Online Training Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Caregiver Stress Syndrome
Keywords: Family caregiving
Lead sponsor: Education University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2024-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel group (treatment vs. waitlist control) design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depressive symptoms
timeFrame: baseline, 1 month, 2 months, 3 months
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: baseline, 1 month, 2 months, 3 months
measure: Caregiver burden
timeFrame: baseline, 1 month, 2 months, 3 months
measure: Positive aspects of caregiving
timeFrame: baseline, 1 month, 2 months, 3 months
Other outcomes:
measure: Caregiving self-efficacy
timeFrame: 3 weeks
measure: Positive reappraisal coping
timeFrame: 3 weeks
Locations:
city: Hong Kong
country: Hong Kong
facility: The Education University of Hong Kong
Study officials:
affiliation: The Education University of Hong Kong
name: Sheung-Tak Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.