Group treatment for self-stigma in people with mental disorders in Northeast Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and feasibility of Narrative Enhancement and Cognitive Therapy (NECT), a group-based intervention designed to reduce self-stigma among individuals with mental disorders. The trial involves 416 patients from 26 mental health centers in Northeast Italy and is structured as a pragmatic, multicenter, randomized controlled trial with two parallel arms. Participants will undergo 20 sessions of NECT, focusing on improving psychological dimensions such as self-esteem, hope, and empowerment while reducing self-stigma. The study aims to address the harmful effects of self-stigma on treatment adherence and quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• Azienda Ospedaliera Universitaria Integrata (AOUI) Verona
  Verona, Italy Recruiting

Study contacts

• Study coordinator: Antonio Lasalvia, MD, PhD
• Email: antonio.lasalvia@univr.it
• Phone: 045 828 3901

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.