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

NCT06567145 | Recruiting

• 1 other identifier: 358CET
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

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.

Conditions

Stigma; Mental Disorders; Self-stigma

Keywords

stigma; narrative enhancement cognitive therapy; narrative therapy; cognitive therapy; mental disorders; self-stigma

Outcome Measures

Primary Outcomes (1)

• Differences in the level of self-stigma

  The primary outcome of the study is the differences in the level of self-stigma (or internalized stigma) between the group receiving the NECT (Narrative Enhancement and Cognitive Therapy) intervention and the control group. These differences will be assessed using the total score from the ISMI (Internalized Stigma of Mental Illness) scale. The ISMI (Internalized Stigma of Mental Illness) scale is a 29-item self-report questionnaire used to measure self-stigma in individuals with mental illness. It includes five subscales: Alienation, Stereotype Endorsement, Discrimination Experience, Social Withdrawal, and Stigma Resistance. Higher scores indicate greater internalized stigma. The measurements will be taken at two time points: at baseline (T0) and at the end of the treatment (T1). The main objective is to observe the change in the total ISMI score over time, comparing the two groups to evaluate the effectiveness of the NECT intervention in reducing self-stigma.

  From enrollment to the end of treatment at 20 weeks

Secondary Outcomes (11)

• Self-esteem

  From enrollment to the end of treatment at 20 weeks

• Hope and expectations about the future

  From enrollment to the end of treatment at 20 weeks

• Empowerment

  From enrollment to the end of treatment at 20 weeks

• Recovery Perception

  From enrollment to the end of treatment at 20 weeks

• Mental wellbeing

  From enrollment to the end of treatment at 20 weeks

Study Arms (2)

Narrative Enhancement and Cognitive Therapy (NECT)

EXPERIMENTAL

Patients assigned to the experimental gropu will receive the Narrative Enhancement and Cognitive Therapy (NECT), a structured psychological intervention aimed at reducing self-stigma in individuals with severe mental illness. It was developed in early 2000s in the USA by Philip Yanos, David Roe and Paul Lysaker. Patients in the experimental group will also receive routine treatment typically provided within their usual care settings.

Behavioral: Narrative Enhancement Cognitive Therapy (NECT)

Control group

NO INTERVENTION

Patients in the control group will continue to receive the routine treatment typically provided within their usual care settings, which usually includes pharmacological treatment + outpatient visits (for monitoring pharmacological treatment and symptom management) + (if needed) other psychosocial treatments (e.g., individual or group therapy, family psychoeducation, cognitive rehabilitation, job placements/supported employment).

Interventions

Narrative Enhancement Cognitive Therapy (NECT) BEHAVIORAL

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.

Narrative Enhancement and Cognitive Therapy (NECT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata (AOUI) Verona

Verona, 37134, Italy

RECRUITING

Related Publications (11)

• Huang LT, Liu CY, Yang CY. Narrative enhancement and cognitive therapy for perceived stigma of chronic schizophrenia: A multicenter randomized controlled trial study. Arch Psychiatr Nurs. 2023 Jun;44:59-68. doi: 10.1016/j.apnu.2023.04.004. Epub 2023 Apr 15.

  PMID: 37197864 BACKGROUND

• Yanos PT, Lysaker PH, Silverstein SM, Vayshenker B, Gonzales L, West ML, Roe D. A randomized-controlled trial of treatment for self-stigma among persons diagnosed with schizophrenia-spectrum disorders. Soc Psychiatry Psychiatr Epidemiol. 2019 Nov;54(11):1363-1378. doi: 10.1007/s00127-019-01702-0. Epub 2019 Apr 1.

  PMID: 30937510 BACKGROUND

• Hansson L, Lexen A, Holmen J. The effectiveness of narrative enhancement and cognitive therapy: a randomized controlled study of a self-stigma intervention. Soc Psychiatry Psychiatr Epidemiol. 2017 Nov;52(11):1415-1423. doi: 10.1007/s00127-017-1385-x. Epub 2017 Apr 19.

  PMID: 28424854 BACKGROUND

• Cavelti M, Rusch N, Vauth R. Is living with psychosis demoralizing? Insight, self-stigma, and clinical outcome among people with schizophrenia across 1 year. J Nerv Ment Dis. 2014 Jul;202(7):521-9. doi: 10.1097/NMD.0000000000000160.

  PMID: 24933416 BACKGROUND

• Yanos PT, Roe D, Lysaker PH. The Impact of Illness Identity on Recovery from Severe Mental Illness. Am J Psychiatr Rehabil. 2010 Apr;13(2):73-93. doi: 10.1080/15487761003756860.

  PMID: 20802840 BACKGROUND

• Livingston JD, Boyd JE. Correlates and consequences of internalized stigma for people living with mental illness: a systematic review and meta-analysis. Soc Sci Med. 2010 Dec;71(12):2150-61. doi: 10.1016/j.socscimed.2010.09.030. Epub 2010 Oct 12.

  PMID: 21051128 BACKGROUND

• Brohan E, Elgie R, Sartorius N, Thornicroft G; GAMIAN-Europe Study Group. Self-stigma, empowerment and perceived discrimination among people with schizophrenia in 14 European countries: the GAMIAN-Europe study. Schizophr Res. 2010 Sep;122(1-3):232-8. doi: 10.1016/j.schres.2010.02.1065. Epub 2010 Mar 26.

  PMID: 20347271 BACKGROUND

• Lasalvia A, Zoppei S, Van Bortel T, Bonetto C, Cristofalo D, Wahlbeck K, Bacle SV, Van Audenhove C, van Weeghel J, Reneses B, Germanavicius A, Economou M, Lanfredi M, Ando S, Sartorius N, Lopez-Ibor JJ, Thornicroft G; ASPEN/INDIGO Study Group. Global pattern of experienced and anticipated discrimination reported by people with major depressive disorder: a cross-sectional survey. Lancet. 2013 Jan 5;381(9860):55-62. doi: 10.1016/S0140-6736(12)61379-8. Epub 2012 Oct 18.

  PMID: 23083627 BACKGROUND

• Pescosolido BA, Medina TR, Martin JK, Long JS. The "backbone" of stigma: identifying the global core of public prejudice associated with mental illness. Am J Public Health. 2013 May;103(5):853-60. doi: 10.2105/AJPH.2012.301147. Epub 2013 Mar 14.

  PMID: 23488508 BACKGROUND

• Angermeyer MC, Dietrich S. Public beliefs about and attitudes towards people with mental illness: a review of population studies. Acta Psychiatr Scand. 2006 Mar;113(3):163-79. doi: 10.1111/j.1600-0447.2005.00699.x.

  PMID: 16466402 BACKGROUND

• Lasalvia A, Bodini L, Cristofalo D, Fin V, Yanos PT, Bonetto C. Assessing the effectiveness and the feasibility of a group-based treatment for self-stigma in people with mental disorders in routine mental health services in North-East Italy: study protocol for a pragmatic multisite randomized controlled trial. Trials. 2025 Jan 31;26(1):35. doi: 10.1186/s13063-025-08739-4.

  PMID: 39891254 DERIVED

MeSH Terms

Conditions

Social Stigma; Mental Disorders

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

Antonio Lasalvia, MD, PhD

CONTACT

045 828 3901; antonio.lasalvia@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry at the Department of Neurosciences, Biomedicine, and Movement Sciences

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 22, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after the publication of the main paper
• Access Criteria: Write an e-mail to antonio.lasalvia@univr.it

Locations

IT (1)