Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06567145

Assessing the Effectiveness and Feasibility of Group-based Treatment for Self-stigma in People With Mental Disorders in Northeast Italy

Led by Universita di Verona · Updated on 2024-11-26

416

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and feasibility of Narrative Enhancement and Cognitive Therapy (NECT), a group-based treatment designed to reduce self-stigma in people with mental disorders. Self-stigma involves internalizing negative stereotypes which can harm treatment adherence, self-esteem, quality of life, and increase despair or suicide risk. This pragmatic, multicenter, randomized controlled trial includes 416 patients from 26 mental health centers in Northeast Italy, aiming to improve psychological outcomes like self-esteem, hope, empowerment, recovery perception, and mental well-being. Participants in the intervention group will attend 20 one-hour NECT group sessions divided into five parts: orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. The therapy helps challenge stigmatizing beliefs and fosters a positive self-narrative. This group therapy is provided alongside participants' usual care, which may include medication and psychosocial treatments. The control group will continue their standard care without NECT. The study lasts about 12 months, with a 2-month recruitment phase, 5 months of intervention, and 5 months for data analysis and publication. Participants will undergo assessments at enrollment and after the 20-week intervention to measure changes in self-stigma, self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma-related stress. Treatment fidelity will be monitored through session recordings. The study also tracks feasibility by evaluating participation rates and feedback. All participants remain under their usual care throughout the study, and data collection includes monitoring care received during the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 18 years or older.
  • Diagnosis of schizophrenia, schizoaffective disorder, schizoid disorder, schizophreniform disorder, bipolar I or II disorder, or major depressive disorder according to DSM-5.
  • Outpatients clinically stable for at least 3 months with no changes in pharmacological treatment during this time.
  • Sufficient knowledge of written and spoken Italian.
  • Score above 1 on the ISMI scale indicating moderate or higher self-stigma.
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent.
  • Intellectual disabilities.
  • Primary diagnosis of personality disorder or substance dependence.
  • Participation in other programs that could influence self-stigma (e.g., social cognitive rehabilitation, social skills training) during the study period.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 5 months

Participants in the intervention group attend 20 group sessions of Narrative Enhancement and Cognitive Therapy (NECT) aimed at reducing self-stigma, while continuing their usual care. Sessions are structured with orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion, each lasting about one hour.

20 group sessions (in-person)

Trial Site Locations

Total: 1 location

1

Azienda Ospedaliera Universitaria Integrata (AOUI) Verona

Verona, Italy, 37134

Actively Recruiting

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Research Team

A

Antonio Lasalvia, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Narrative enhancement and cognitive therapy for perceived stigma of chronic schizophrenia: A multicenter randomized controlled trial study.

Li-Ting Huang, Chieh-Yu Liu, Chiu-Yueh Yang

https://pubmed.ncbi.nlm.nih.gov/37197864

A randomized-controlled trial of treatment for self-stigma among persons diagnosed with schizophrenia-spectrum disorders.

Philip T Yanos, Paul H Lysaker, Steven M Silverstein...

https://pubmed.ncbi.nlm.nih.gov/30937510

The effectiveness of narrative enhancement and cognitive therapy: a randomized controlled study of a self-stigma intervention.

Lars Hansson, Annika Lexén, Joacim Holmén

https://pubmed.ncbi.nlm.nih.gov/28424854

Is living with psychosis demoralizing? Insight, self-stigma, and clinical outcome among people with schizophrenia across 1 year.

Marialuisa Cavelti, Nicolas Rüsch, Roland Vauth

https://pubmed.ncbi.nlm.nih.gov/24933416

Correlates and consequences of internalized stigma for people living with mental illness: a systematic review and meta-analysis.

James D Livingston, Jennifer E Boyd

https://pubmed.ncbi.nlm.nih.gov/21051128

Self-stigma, empowerment and perceived discrimination among people with schizophrenia in 14 European countries: the GAMIAN-Europe study.

Elaine Brohan, Rodney Elgie, Norman Sartorius...

https://pubmed.ncbi.nlm.nih.gov/20347271

Global pattern of experienced and anticipated discrimination reported by people with major depressive disorder: a cross-sectional survey.

Antonio Lasalvia, Silvia Zoppei, Tine Van Bortel...

https://pubmed.ncbi.nlm.nih.gov/23083627