SchizophreniaNCT06563752
Exploring the Effectiveness of Digital Anti-stigma Therapy on Illness Perception and Perceived Stigma in Patients With Schizophrenia and Their Primary Caregivers
A study testing Participants will use 3D glasses to view VR educational information and routine care in people with Schizophrenia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Participants will use 3D glasses to view VR educational information and routine care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Patient group
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Yang Ming Chiao Tung University
Taipei, 112304
Chiu-Yueh Yang, PhD, +8860228267388, cyyang530904@nycu.edu.tw
About this study
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.
Read the 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
- Being tested
- Participants will use 3D glasses to view VR educational information, routine care
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will use 3D glasses to view VR educational informationOther
Participants will use 3D glasses to view VR educational information, which includes:
- Understanding of psychiatric symptoms, including symptoms, disease course, treatment, and prognosis.
- Knowledge about medications, their relationship with symptom stabilization, and handling of side effects.
- Schizophrenia as a chronic illness, with analogies to other chronic diseases.
- Signs of disease relapse.
- How to manage ongoing psychiatric symptoms of schizophrenia, including delusions, hallucinations, paranoia, and negative symptoms.
- Strategies for interacting and communicating with patients.
- Stress management and adjustment, as well as suicide prevention.
- Available resources.
routine careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Participants will use 3D glasses to view VR educational information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563752
- Sponsor's protocol ID
- 1130113-01
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of Digital Anti-stigma Therapy on Illness Perception and Perceived Stigma in Patients With Schizophrenia and Their Primary Caregivers
- ClinicalTrials.gov ID
- NCT06563752
- Acronym / sponsor ID
- 1130113-01
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care | Placebo comparator | Other: routine careBefore 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 | Experimental | Other: Participants will use 3D glasses to view VR educational informationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- Patient group
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants will use 3D glasses to view VR educational informationParticipants 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. | Other | Experimental |
| routine careBefore 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 |
Primary outcome
Positive and Negative Syndrome Scale
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
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 Schedule for the Assessment of Insight
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
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.
Internalized Stigma of Mental Illness
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
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.
Medication Adherence Rating Scale
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
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.
Drug Attitude Inventory-10
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
This is a self-report scale primarily used to assess patients' attitudes towards medication.
Illness Perception Questionnaire-Revised Version for Families of Patients with Schizophrenia
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
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.
Affiliate Stigma Scale
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
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.
Caregiver Burden Scale
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
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.
World Health Organisation- Five Well-Being Index
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
To assess the perception of Well-Being over the past two weeks.
Multidimensional Scale of Perceived Social Support
Time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
To assess social support from different sources. The scale consists of 12 items across three dimensions: family, friends, and significant others.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants will use 3D glasses to view VR educational information and routine care in people with Schizophrenia, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiu-Yueh Yang, PhD (+8860228267388, Cyyang530904@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (time frame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.