- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06409455
Positive Dementia Caregiving: Clinical Trial of an Online Training Program
Positive Dementia Caregiving in 30 Days: Randomized Controlled Trial of a Self-guided Automated Online Training Program
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Education University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention
Caregiver training
|
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.
Other Names:
|
|
Other: Waitlist control
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: baseline, 1 month, 2 months, 3 months
|
Patient Health Questionnaire-9; possible scores 0-27, higher = more depressed
|
baseline, 1 month, 2 months, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety symptoms
Time Frame: baseline, 1 month, 2 months, 3 months
|
Profile of Mood States - Anxiety Subscale, brief version; possible scores 0-24, higher = more anxious
|
baseline, 1 month, 2 months, 3 months
|
|
Caregiver burden
Time Frame: baseline, 1 month, 2 months, 3 months
|
Zarit Burden Interview, brief version; possible scores 0-24, higher = more burden
|
baseline, 1 month, 2 months, 3 months
|
|
Positive aspects of caregiving
Time Frame: baseline, 1 month, 2 months, 3 months
|
Positive Aspects of Caregiving Scale, brief version; possible scores 6-30; higher = more positive aspects of caregiving
|
baseline, 1 month, 2 months, 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiving self-efficacy
Time Frame: 3 weeks
|
Revised Scale for Caregiving Self-efficacy, brief version; possible scores 0-100, higher = more self-efficacy
|
3 weeks
|
|
Positive reappraisal coping
Time Frame: 3 weeks
|
Brief-COPE, Positive Reframing Subscale; possible scores 2-8, higher = more use of positive reframing
|
3 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sheung-Tak Cheng, PhD, The Education University of Hong Kong
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18622322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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