Exploring the Effectiveness of Digital Anti-stigma Therapy on Illness Perception and Perceived Stigma in Patients With Schizophrenia and Their Primary Caregivers

NCT ID: NCT06563752

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2027-12-31

Brief Summary

This study aims to investigate the relationship between illness insight, self-stigma in patients with schizophrenia, and the awareness and associated stigma experienced by their families, as well as the predictors of these factors. The study will use information technology strategies for educational purposes, specifically employing 3D glasses for delivering this education. The goal is to develop a disease adaptation program that involves both patients and their families, helping to enhance disease awareness and improve stigma experiences.

Detailed Description

• Background:** Research has confirmed that family members of patients with schizophrenia often lack awareness of the illness and are affected by stigma, leading them to be reluctant to seek help. This reluctance impacts patients' medication adherence, increases the severity of the illness, and results in recurrent episodes and deteriorating social functioning. In Chinese societies, where maintaining face is important, the caregiving burden on families and associated stigma are even more pronounced. In Taiwan, there is a lack of interventions using virtual reality for family members.
• Objective:** To evaluate the effectiveness of a digital anti-stigma therapy in improving illness awareness and reducing associated stigma among patients with schizophrenia and their family members.
• Methods:** This pioneering study employs a randomized controlled trial design, involving 180 patients with schizophrenia and their family members from psychiatric medical institutions in northern Taiwan. Participants are randomly assigned to two groups: one receiving standard care and the other receiving standard care plus VR video intervention. Research tools include questionnaires on illness awareness (family and patient versions), internalized stigma scales, and family-associated internalized stigma scales. Data collection occurs at baseline, immediately post-intervention, and three months later. The t-test and χ2 test are used to assess group homogeneity, and generalized estimating equations are applied to explore the effectiveness of the intervention after controlling for basic attributes.
• Expected Results/Clinical Application:** The experimental group is anticipated to show significantly greater improvement in outcome measures compared to the control group. Implementing this intervention clinically could enhance family members' awareness of the illness and improve their experience of stigma, thereby supporting patients in adapting to their illness and stabilizing their community living.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Routine care

Before discharge, provide routine discharge preparation instructions and offer a disease education booklet with relevant health information. Follow up with two phone calls after discharge, on the 7th and 30th days.

Group Type: PLACEBO_COMPARATOR

routine care

Intervention Type: OTHER

Before discharge, provide routine discharge preparation instructions and offer a disease education booklet with relevant health information. Follow up with two phone calls after discharge, on the 7th and 30th days.

Experimental

The experimental group, referred to as the Dyad, involved both the caregiver and the patient wearing 3D glasses to watch educational VR content. The VR content included the following topics:

1. Understanding psychiatric symptoms, including symptoms, disease course, treatment, and prognosis.

2. Knowledge of medications and their relationship to symptom stability, as well as how to manage side effects.

3. Schizophrenia as a chronic illness, drawing comparisons to other chronic diseases.

4. Signs of disease relapse.

5. How to manage persistent psychotic symptoms of schizophrenia, such as delusions, hallucinations, paranoia, and negative symptoms.

6. How to interact and communicate with the patient.

7. Coping with stress, stress management, and suicide prevention.

8. Available resources.

Group Type: EXPERIMENTAL

Participants will use 3D glasses to view VR educational information

Intervention Type: OTHER

Participants will use 3D glasses to view VR educational information, which includes:

1. Understanding of psychiatric symptoms, including symptoms, disease course, treatment, and prognosis.

2. Knowledge about medications, their relationship with symptom stabilization, and handling of side effects.

3. Schizophrenia as a chronic illness, with analogies to other chronic diseases.

4. Signs of disease relapse.

5. How to manage ongoing psychiatric symptoms of schizophrenia, including delusions, hallucinations, paranoia, and negative symptoms.

6. Strategies for interacting and communicating with patients.

7. Stress management and adjustment, as well as suicide prevention.

8. Available resources.

Interventions

Participants will use 3D glasses to view VR educational information

Participants will use 3D glasses to view VR educational information, which includes:

1. Understanding of psychiatric symptoms, including symptoms, disease course, treatment, and prognosis.

2. Knowledge about medications, their relationship with symptom stabilization, and handling of side effects.

3. Schizophrenia as a chronic illness, with analogies to other chronic diseases.

4. Signs of disease relapse.

5. How to manage ongoing psychiatric symptoms of schizophrenia, including delusions, hallucinations, paranoia, and negative symptoms.

6. Strategies for interacting and communicating with patients.

7. Stress management and adjustment, as well as suicide prevention.

8. Available resources.

Intervention Type: OTHER

routine care

Before discharge, provide routine discharge preparation instructions and offer a disease education booklet with relevant health information. Follow up with two phone calls after discharge, on the 7th and 30th days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patient group

1. Age ≥ 18 years;

2. Patients who meet the DSM-5 criteria for schizophrenia or the ICD-10 diagnosis code F20, including those who are expected to be discharged from a psychiatric ward within two weeks or are outpatients;

3. Have family members involved in caregiving (i.e., relatives who assist with daily needs, supervise medication, help with medical visits, and maintain contact with hospital staff during hospitalization, including non-blood-related cohabitants);

4. Are literate, able to independently read and complete questionnaires, can operate basic tablet or smartphone functions after instruction, and are willing to participate in this study.

Family group

1. Age ≥ 18 years;

2. Family members providing care for psychiatric outpatients or inpatients diagnosed with schizophrenia (i.e., relatives who assist with daily needs, supervise medication, help with medical visits, and maintain contact with hospital staff during hospitalization, including non-blood-related cohabitants);

3. Literate, able to independently read and complete questionnaires, can operate basic tablet or smartphone functions after instruction, and are willing to participate.

Exclusion Criteria

Patient group

(1) Patients with co-occurring personality disorders, substance or alcohol addiction, or organic brain damage; (2) Individuals living alone without close family contact; (3) Patients who will reside in a rehabilitation facility after discharge. Family group

1. Individuals with mental disorders, who are illiterate, or unable to independently read and complete questionnaires.

2. Family members who cannot use smartphones or do not have access to smart technology.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Yang Ming Chiao Tung University

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Chiu-Yueh Yang, PhD

Role: CONTACT

Cyyang530904@nycu.edu.tw

+8860228267388

Jia-Min Li, MSN

Role: CONTACT

louislee0720@gmail.com

+886972988076

Facility Contacts

Chiu-Yueh Yang, PhD

Role: primary

cyyang530904@nycu.edu.tw

+8860228267388

Other Identifiers

1130113-01

Identifier Type: -

Identifier Source: org_study_id