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

NCT06563752 | Not Yet Recruiting

• 1 other identifier: 1130113-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (10)

• Positive and Negative Syndrome Scale

  This scale primarily assesses the severity of psychiatric disorders and was originally developed by Kay et al. (1987). It includes three dimensions: positive symptoms, negative symptoms, and general psychopathology, with a total of 30 items.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• The Schedule for the Assessment of Insight

  This is a semi-structured interview questionnaire developed by David (1990), primarily used to assess illness insight and perceptions of the illness in psychiatric disorders. It includes three aspects: illness awareness, the importance of treatment, and disease recognition, with a total of 7 items.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• Internalized Stigma of Mental Illness

  This scale primarily measures the subjective self-stigma experienced by individuals with mental illness and was developed in collaboration with patients. It includes 29 items across five dimensions: alienation, stereotype endorsement, perceived discrimination, social withdrawal, and anti-stigma coping ability.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• Medication Adherence Rating Scale

  This self-report scale assesses patients' medication attitudes and adherence behaviors over the past week. It consists of 10 true/false questions, with scores ranging from 1 to 7 indicating poor adherence and 8 to 10 indicating good adherence.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• Drug Attitude Inventory-10

  This is a self-report scale primarily used to assess patients' attitudes towards medication.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• Illness Perception Questionnaire-Revised Version for Families of Patients with Schizophrenia

  This is a survey questionnaire designed to assess illness awareness among the family members of individuals with schizophrenia. It includes 38 items across 7 dimensions, evaluating participants' knowledge about schizophrenia and its management, causes, prevalence, prognosis, and treatment.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• Affiliate Stigma Scale

  The primary purpose is to assess the caregiver's perception of internalized stigma. The scale consists of 22 items, covering three aspects: cognition, emotion, and behavior.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• Caregiver Burden Scale

  The main purpose is to assess the burden level of caregivers of psychiatric patients. The scale contains 18 questions, measuring the actual problems and feelings that arise from caregiving. The scale includes five subdimensions.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• World Health Organisation- Five Well-Being Index

  To assess the perception of Well-Being over the past two weeks.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

• Multidimensional Scale of Perceived Social Support

  To assess social support from different sources. The scale consists of 12 items across three dimensions: family, friends, and significant others.

  The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.

Study Arms (2)

Routine care

PLACEBO COMPARATOR

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.

Other: routine care

Experimental

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.

Other: Participants will use 3D glasses to view VR educational information

Interventions

Participants will use 3D glasses to view VR educational information 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.

Experimental

routine care 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.

Routine care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient group
• Age ≥ 18 years;
• 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;
• 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);
• 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
• Age ≥ 18 years;
• 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);
• Literate, able to independently read and complete questionnaires, can operate basic tablet or smartphone functions after instruction, and are willing to participate.

You may not qualify if:

• 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
• Individuals with mental disorders, who are illiterate, or unable to independently read and complete questionnaires.
• Family members who cannot use smartphones or do not have access to smart technology.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112304, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Chiu-Yueh Yang, PhD

CONTACT

+8860228267388; Cyyang530904@nycu.edu.tw

Jia-Min Li, MSN

CONTACT

+886972988076; louislee0720@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)