Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers

April 6, 2025 updated by: The Hong Kong Polytechnic University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in depressive symptoms
Time Frame: 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.
Pre-intervention, immediately post-intervention, 6 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in caregiving appraisal
Time Frame: 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.
Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in stress and anxiety
Time Frame: 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.
Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in patient neuropsychiatric symptoms
Time Frame: 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).
Pre-intervention, immediately post-intervention, 6 months post-intervention
Changes in quality of life
Time Frame: 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.
Pre-intervention, immediately post-intervention, 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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