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NCT Number: NCT05927805

E-bibliotherapy for Informal Caregivers of People With Dementia

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.

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Key information

Conditions

Dementia Behavior Brain Diseases Caregiver Stress Syndrome Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-bibliotherapy

Other

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.

Control

Other

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.

Primary outcomes

  1. Changes on psychological well-being

    Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention

    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.

Secondary outcomes

  1. Changes on caregiving appraisal

    Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention

    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.

  2. Changes on mental health

    Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention

    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.

  3. Changes on biomarker of stress

    Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention

    Saliva cortisol concentration will be used.

  4. Changes on health-related quality of life

    Time frame: Pre-intervention, immediately post-intervention, three and six-month post-intervention

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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