## Protocol Section
### Identification Module
**NCT ID:** NCT06413849

**Brief Title:** Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers

**Official Title:** Telephone-coached "Graphic Narrative" Bibliotherapy for Informal Caregivers of People With Dementia

#### Organization Study ID Info
**ID:** P0047108
#### Organization
**Class:** OTHER
**Full Name:** The Hong Kong Polytechnic University
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Hong Kong Polytechnic University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Dementia Caregiver

- Depressive Symptoms

- Caregiving Appraisal

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 128

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Eight weekly sessions of telephone-coached graphic narrative bibliotherapy

**Intervention Names:**

- Other: Telephone coached graphic narrative bibliotherapy

**Label:** Graphic narrative bibliotherapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Reading an educational booklet

**Intervention Names:**

- Other: Control group

**Label:** Control group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Graphic narrative bibliotherapy

**Description:** Eight weekly sessions of telephone coached graphic narrative bibliotherapy

**Name:** Telephone coached graphic narrative bibliotherapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** Reading educational booklet

**Name:** Control group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Changes in depressive symptoms

**Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention

#### Secondary Outcomes

**Description:** 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.

**Measure:** Changes in caregiving appraisal

**Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention

**Description:** Stress and anxiety will be measured with the stress and anxiety subscales of DASS-21

**Measure:** Changes in stress and anxiety

**Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention

**Description:** Patient neuropsychiatric symptoms: will be measured with the Neuropsychiatric Inventory (NPI). NPI evaluates 12 common neuropsychiatric disturbances in dementia

**Measure:** Changes in patient neuropsychiatric symptoms

**Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention

**Description:** 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

**Measure:** Changes in quality of life

**Time Frame:** Pre-intervention, immediately post-intervention, 6 months post-intervention

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6904

- Name: Dementia

- Relevance: HIGH

- As Found: Dementia

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depressive Symptoms

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003704

- Term: Dementia

- ID: D000003863

- Term: Depression

### Misc Info Module

- Version Holder: 2024-05-31
