NCT06567145 A Group-based Treatment for Self-stigma in People With Mental Disorders in North-east Italy
| NCT ID | NCT06567145 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita di Verona |
| Condition | Stigma |
| Study Type | INTERVENTIONAL |
| Enrollment | 416 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 416 participants in total. It began in 2024-10-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Self-stigma refers to the internalization of negative stereotypes by individuals with mental disorders, leading to beliefs that they are dangerous, aggressive, or incapable of working. This phenomenon has harmful effects on various aspects of life, such as adherence to treatment, self-esteem, quality of life, and can increase feelings of despair and suicide risk. To address these issues, the Narrative Enhancement and Cognitive Therapy (NECT) was developed. NECT is a group-based intervention consisting of 20 sessions designed to reduce self-stigma in individuals with mental disorders. This study aims to evaluate the efficacy and feasibility of NECT in 416 patients from 26 mental health centers in Northeast Italy. It is structured as a pragmatic, multicenter, randomized controlled trial with two parallel arms. The study will assess the impact of NECT on several psychological dimensions, including levels of self-stigma, self-esteem, hope, empowerment, perception of recovery, mental well-being, and stigma-related stress. The findings of this research are expected to contribute to the understanding of effective treatments for patients with mental disorders, particularly those burdened by high levels of self-stigma, and to improve their recovery outcomes.
Eligibility Criteria
Inclusion Criteria: 1. Participants must be 18 years or older. 2. Individuals must have a diagnosis of schizophrenia, schizoaffective disorder, schizoid disorder, schizophreniform disorder, bipolar I or II disorder, or major depressive disorder, according to DSM-5 criteria. 3. Participants must be outpatients with clinical stability for at least 3 months, with no changes in pharmacological treatment during this period. 4. Participants must have sufficient knowledge of written and spoken Italian. 5. Participants must score above 1 on the ISMI (Internalized Stigma of Mental Illness) scale, indicating at least moderate levels of self-stigma. Exclusion Criteria: 1. Individuals unable to provide informed consent are excluded. 2. Participants with intellectual disabilities are excluded. 3. Individuals with primary diagnosis of personality disorder or substance dependence condition are excluded. 4. Participants engaged in other programs that could influence self-stigma (e.g., social cognitive rehabilitation, social skills training) during the study are excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06567145 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stigma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06567145 currently recruiting?
Yes, NCT06567145 is actively recruiting participants. Contact the research team at antonio.lasalvia@univr.it for enrollment information.
Where is the NCT06567145 trial being conducted?
This trial is being conducted at Verona, Italy.
Who is sponsoring the NCT06567145 clinical trial?
NCT06567145 is sponsored by Universita di Verona. The trial plans to enroll 416 participants.