Positive Dementia Caregiving: Clinical Trial of an Online Training Program

Caregiver Stress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409455
• Other study ID #: 18622322
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Education University of Hong Kong
• Contact: Sheung-Tak Cheng, PhD
• Phone: +852 2948 6563
• Email: takcheng[@]eduhk.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Stress Syndrome
• Dementia

Intervention

Behavioral:
• Positive Dementia Caregiving in 30 Days
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Education University of Hong Kong	The Hong Kong Polytechnic University

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiving self-efficacy	Revised Scale for Caregiving Self-efficacy, brief version; possible scores 0-100, higher = more self-efficacy	3 weeks
Other	Positive reappraisal coping	Brief-COPE, Positive Reframing Subscale; possible scores 2-8, higher = more use of positive reframing	3 weeks
Primary	Depressive symptoms	Patient Health Questionnaire-9; possible scores 0-27, higher = more depressed	baseline, 1 month, 2 months, 3 months
Secondary	Anxiety symptoms	Profile of Mood States - Anxiety Subscale, brief version; possible scores 0-24, higher = more anxious	baseline, 1 month, 2 months, 3 months
Secondary	Caregiver burden	Zarit Burden Interview, brief version; possible scores 0-24, higher = more burden	baseline, 1 month, 2 months, 3 months
Secondary	Positive aspects of caregiving	Positive Aspects of Caregiving Scale, brief version; possible scores 6-30; higher = more positive aspects of caregiving	baseline, 1 month, 2 months, 3 months