Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers

NCT06413849 | Recruiting

• 1 other identifier: P0047108
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia Caregiver; Depressive Symptoms; Caregiving Appraisal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in caregiving appraisal

  Pre-intervention, immediately post-intervention, 6 months post-intervention

• Changes in stress and anxiety

  Pre-intervention, immediately post-intervention, 6 months post-intervention

• Changes in patient neuropsychiatric symptoms

  Pre-intervention, immediately post-intervention, 6 months post-intervention

• Changes in quality of life

  Pre-intervention, immediately post-intervention, 6 months post-intervention

Study Arms (2)

Graphic narrative bibliotherapy

EXPERIMENTAL

Eight weekly sessions of telephone-coached graphic narrative bibliotherapy

Other: Telephone coached graphic narrative bibliotherapy

Control group

SHAM COMPARATOR

Reading an educational booklet

Other: Control group

Interventions

Telephone coached graphic narrative bibliotherapy OTHER

Eight weekly sessions of telephone coached graphic narrative bibliotherapy

Graphic narrative bibliotherapy

Control group OTHER

Reading educational booklet

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong SAR, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)