Clinical trial NCT06563752: Exploring the Effectiveness of Digital Anti-stigma Therapy on Illness Perception and Perceived Stigma in Patients With Schizophrenia and Their Primary Caregivers
Official title: Exploring the Effectiveness of Digital Anti-stigma Therapy on Illness Perception and Perceived Stigma in Patients With Schizophrenia and Their Primary Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: The Schedule for the Assessment of Insight
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: Internalized Stigma of Mental Illness
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: Medication Adherence Rating Scale
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: Drug Attitude Inventory-10
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: Illness Perception Questionnaire-Revised Version for Families of Patients with Schizophrenia
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: Affiliate Stigma Scale
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: Caregiver Burden Scale
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: World Health Organisation- Five Well-Being Index
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
measure: Multidimensional Scale of Perceived Social Support
timeFrame: The assessment will be conducted three times: before the intervention, immediately after the intervention, and three months after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
References: