E-bibliotherapy for Informal Caregivers of People With Dementia

Study Overview
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Brief Summary
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The objective of this study is to test the efficacy of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia as compared with a control group.

Detailed Description
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This project is a two-arm randomized controlled trial evaluating the effects of e-bibliotherapy on improving the psychological well-being of informal caregivers of people with dementia. One hundred and ninety-two informal caregivers of people with dementia will be recruited. Participants in the intervention group will receive eight weekly e-bibliotherapy sessions. The control group will get access to the same e-bibliotherapy app but accept only general daily living knowledge. Psychological well-being, caregiving appraisal, mental health, biomarker of stress, and health-related quality of life will be measured to test the effects of e-bibliotherapy immediately post-intervention, three months post-intervention, and six months post-intervention. Focus group interviews will be conducted immediately post-intervention to explore caregivers' experiences participating in this study.

Official Title
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Effects of E-bibliotherapy on the Psychological Well-being of Informal Caregivers of People With Dementia: A Randomized Controlled Trial

Conditions
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Dementia, Caregiver Stress Syndrome, Psychological Well-Being

Intervention / Treatment
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* Other: E-bibliotherapy
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary caregivers aged 18 or above; provide unpaid regular care to a person with mild to moderately severe dementia (measured by Global Deterioration Scale, GDS=4 6); have cared for the care recipient for at least six months; assist with at least one of the care recipient's daily activities; use a smartphone or tablet; can read Chinese. Exclusion Criteria: caregivers with unstable physical or mental conditions; have cognitive impairment; are undergoing acute treatment or have not yet stabilized on their chronic medication; are involved in another interventional study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Eight weekly sessions of e-bibliotherapy. Participants in the intervention group will use the e-bibliotherapy app we develop, and accept e-bibliotherapy via the app. | Other: E-bibliotherapy<br>* Participants in the intervention group will accept eight weekly sessions of e-bibliotherapy. The e-bibliotherapy will be delivered via the e-bibliotherapy app we develop and includes eight e-bibliotherapy sessions, each focusing on one active component that may affect a caregiver's mental well-being.<br>|
| Sham Comparator: Control group<br>Eight weekly sessions of self-learning of general daily living knowledge that this different from the intervention contents from the same e-bibliotherapy app. | Other: Control<br>* The control group will give access to the same e-bibliotherapy app, but only be authorized to access general daily living knowledge that is different from the intervention contents. They will also be asked to finish a session each week for eight weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on psychological well-being | Psychological well-being will be measured by the Chinese version of Ryff's Psychological Well-being Scale. It is a 6-point Likert scale with 1=strongly disagree to 6=totally agree. It includes 18 items. A higher score indicates better psychological well-being. | Pre-intervention, immediately post-intervention, three and six-month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on caregiving appraisal | Caregiving appraisal will be measured by the Chinese version of the Caregiving Appraisal Scale. It is a 5-point Likert scale (1=extremly disagree, 5=strongly agree) including 26 items. Higher scores indicate more positive caregiving appraisal. | Pre-intervention, immediately post-intervention, three and six-month post-intervention | 
| Changes on mental health | Mental health will be measured by the Chinese version of the Depression Anxiety Stress Scale-21 (DASS-21). DASS-21 is a 4-point Likert scale (0=totally unfit my condition, 3=very fit my condition). It includes 21 items. Higher scores indicate worse mental health problems. | Pre-intervention, immediately post-intervention, three and six-month post-intervention | 
| Changes on biomarker of stress | Saliva cortisol concentration will be used. | Pre-intervention, immediately post-intervention, three and six-month post-intervention | 
| Changes on health-related quality of life | Health-related quality of life will be measured by the 12-item Short Form Survey (SF-12). SF-12 includes 12 items. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. | Pre-intervention, immediately post-intervention, three and six-month post-intervention |