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NCT Number: NCT06413849

Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers

This study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group.

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Key information

Conditions

Dementia Caregiver Behavior Behavioral Symptoms Caregiving Appraisal Depression Depressive Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong SAR, Hong Kong

Location status: Recruiting

Location contact

Shanshan Wang

CONTACT

[email protected]

27664696

About this study

This is a two-arm cluster randomized controlled trial using a repeated-measures design to examine the effects of telephone-coached graphic narrative bibliotherapy on 128 (64 per group) informal caregivers of people with dementia. Participants in the intervention group will receive eight weekly telephone-coached graphic narrative bibliotherapy sessions, plus two face-to-face booster sessions and two follow-up sessions. The control group will receive an education booklet and check-in calls. Caregiver depressive symptoms, stress and anxiety, caregiving appraisal, care-recipient neuropsychiatric symptoms, and quality of life will be measured to test the intervention's effects immediately after completion and at a 6-month follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • provide unpaid care to a person diagnosed with early to moderate stage dementia;
  • provide at least 14 hours of care a week for at least 3 months
  • aged 18 years or above
  • able to read
  • have depressive symptoms
  • use a message application

Exclusion criteria

  • with an unstable physical or mental condition
  • with cognitive impairment
  • receiving medical, psychological, or psychiatric treatment for depression
  • have been included in another interventional study

Treatment and study plan

Telephone coached graphic narrative bibliotherapy

Other

Eight weekly sessions of telephone coached graphic narrative bibliotherapy

Control Group

Other

Reading educational booklet

Primary outcomes

  1. Changes in depressive symptoms

    Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention

    Depressive symptoms will be measured with the Chinese version of the Depression Anxiety Stress Scale-21. It is a 4-point Likert scale consisting of 21 items that measure levels ofdepression, anxiety, and stress in participants. The total score ranges from 0-63, with the depression subscale score ranges from 0-21. Higher scores indicategreater severity of mental health problems.

Secondary outcomes

  1. Changes in caregiving appraisal

    Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention

    Caregiving appraisal will be assessed using the Caregiving Appraisal Scale. It is a 26-item Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The score ranges from 26 to 130. Higher scores on this scale indicate more positive caregiving appraisal.

  2. Changes in stress and anxiety

    Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention

    Stress and anxiety will be measured with the stress and anxiety subscales of the Depression, anxiety and stress scale-21 (DASS-21). The total score of the full scale ranges from 0-63, with the anxiety and stress subscale score both range from 0-21.

  3. Changes in patient neuropsychiatric symptoms

    Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention

    Patient neuropsychiatric symptoms: will be measured with the Neuropsychiatric Inventory (NPI). NPI evaluates 12 common neuropsychiatric disturbances in dementia. The presence of problematic behaviors in each domain is assessed by asking an informant a screening question followed by a series of yes/no questions. The frequency of a symptom is created from 1 (rarely) to 4 (very often), and severity is rated from 1 (mild) to 3 (severe).

  4. Changes in quality of life

    Time frame: Pre-intervention, immediately post-intervention, 6 months post-intervention

    Quality of life will be measured with the Brief Older People's Quality of Life Questionnaire (OPQOL-Brief). It is a 13-item, 5-point Likert scale to measure the quality of life for older adults. The total score ranges from 13 to 65, with higher scores indicating a better quality of life.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Telephone-coached "Graphic Narrative" Bibliotherapy for Informal Caregivers of People With Dementia

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
Apr 9, 2025

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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