RecruitingNot ApplicableNCT06567145

A Group-based Treatment for Self-stigma in People With Mental Disorders in North-east 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

Sponsor

Universita di Verona

Enrollment

416 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Mental Disorders Stigma Self-stigma

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

Min Age: 18 Years

Inclusion Criteria5

Participants must be 18 years or older.
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.
Participants must be outpatients with clinical stability for at least 3 months, with no changes in pharmacological treatment during this period.
Participants must have sufficient knowledge of written and spoken Italian.
Participants must score above 1 on the ISMI (Internalized Stigma of Mental Illness) scale, indicating at least moderate levels of self-stigma.

Exclusion Criteria4

Individuals unable to provide informed consent are excluded.
Participants with intellectual disabilities are excluded.
Individuals with primary diagnosis of personality disorder or substance dependence condition are excluded.
Participants engaged in other programs that could influence self-stigma (e.g., social cognitive rehabilitation, social skills training) during the study are excluded.

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Interventions

BEHAVIORALNarrative Enhancement Cognitive Therapy (NECT)

The Narrative Enhancement and Cognitive Therapy (NECT) consists of 20 group sessions divided into five parts: orientation (2 sessions), psychoeducation on stigma (3 sessions), cognitive restructuring (7 sessions), narrative enhancement (7 sessions), and a concluding reflection (1 session). The program helps participants challenge self-stigmatizing beliefs, develop coping skills, and create a new, positive narrative about themselves. Each session lasts about an hour, with a structured format of introduction, main discussion, and conclusion, encouraging active participation and reflection on personal experiences. The intervention ultimately fosters self-efficacy, control, and hope for the future.