Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers

Not Applicable

Recruiting

• Conditions: Dementia Caregiver; Depressive Symptoms; Caregiving Appraisal
• Interventions: Other: Telephone coached graphic narrative bibliotherapy; Other: Control group

• Registration Number: NCT06413849
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-14
• Study Start: 2024-12-01
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Graphic narrative bibliotherapy	Telephone coached graphic narrative bibliotherapy	Eight weekly sessions of telephone-coached graphic narrative bibliotherapy
Control group	Control group	Reading an educational booklet

Primary Outcome Measures

Name	Time	Method
Changes in depressive symptoms	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 Outcome Measures

Name	Time	Method
Changes in stress and anxiety	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.
Changes in caregiving appraisal	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.
Changes in quality of life	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.
Changes in patient neuropsychiatric symptoms	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).

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong SAR, Hong Kong