Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers

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

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

Study Overview

• Status: Recruiting
• Conditions: Depressive Symptoms; Dementia Caregiver; Caregiving Appraisal
• Intervention / Treatment: Other: Telephone coached graphic narrative bibliotherapy; Other: Control 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 Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong SAR, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Shanshan Wang; Phone Number: 27664696; Email: shan-shan.wang@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Graphic narrative bibliotherapy; Eight weekly sessions of telephone-coached graphic narrative bibliotherapy	Other: Telephone coached graphic narrative bibliotherapy; Eight weekly sessions of telephone coached graphic narrative bibliotherapy
Sham Comparator: Control group; Reading an educational booklet	Other: Control group; Reading educational booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in depressive symptoms	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.	Pre-intervention, immediately post-intervention, 6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in caregiving appraisal	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.	Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in stress and anxiety	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.	Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in patient neuropsychiatric symptoms	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).	Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in quality of life	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.	Pre-intervention, immediately post-intervention, 6 months post-intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Depression; Dementia
• Other Study ID Numbers: P0047108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No