Group treatment for self-stigma in people with mental disorders in Northeast Italy
Assessing the Effectiveness and Feasibility of Group-based Treatment for Self-stigma in People With Mental Disorders: a Pragmatic Multisite Randomized Controlled Trial in Routine Mental Health Services in North-east Italy
NA · Universita di Verona · NCT06567145
This study is testing a group therapy called Narrative Enhancement and Cognitive Therapy to see if it can help people with mental disorders in Northeast Italy feel better about themselves and reduce feelings of self-stigma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 416 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universita di Verona (other) |
| Locations | 1 site (Verona) |
| Trial ID | NCT06567145 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific mental health diagnoses who exhibit moderate levels of self-stigma.
Not a fit: Patients with primary personality disorders or substance dependence, as well as those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the self-esteem and quality of life for patients with mental disorders by reducing self-stigma.
How similar studies have performed: Previous studies have shown promising results in reducing self-stigma through similar therapeutic approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Verona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stigma, Mental Disorders, Self-stigma, stigma, narrative enhancement cognitive therapy, narrative therapy, cognitive therapy, mental disorders