Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413849
• Other study ID #: P0047108
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Depression
• Depressive Symptoms

Intervention

Other:
• Telephone coached graphic narrative bibliotherapy
Eight weekly sessions of telephone coached graphic narrative bibliotherapy
• Control group
Reading educational booklet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Higher scores indicategreater severity of mental health problems.	Pre-intervention, immediately post-intervention, 6 months post-intervention
Secondary	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). Higher scores on this scale indicate more positive caregiving appraisal.	Pre-intervention, immediately post-intervention, 6 months post-intervention
Secondary	Changes in stress and anxiety	Stress and anxiety will be measured with the stress and anxiety subscales of DASS-21	Pre-intervention, immediately post-intervention, 6 months post-intervention
Secondary	Changes in patient neuropsychiatric symptoms	Patient neuropsychiatric symptoms: will be measured with the Neuropsychiatric Inventory (NPI). NPI evaluates 12 common neuropsychiatric disturbances in dementia	Pre-intervention, immediately post-intervention, 6 months post-intervention
Secondary	Changes in quality of life	Quality of life will be measured with the Quality of Life-Alzheimer's Disease Scale. It is a 13-item 4-point Likert scale to measure the quality of life for adults with or without dementia	Pre-intervention, immediately post-intervention, 6 months post-intervention