A Group-based Treatment for Self-stigma in People With Mental Disorders in North-east Italy
NCT Number: NCT06567145
Acronym: NECT-ITA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stigma|Mental Disorders|Self-stigma
Interventions: BEHAVIORAL: Narrative Enhancement Cognitive Therapy (NECT)
Sponsor: Universita di Verona
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 416
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-10-01
Locations: Azienda Ospedaliera Universitaria Integrata (AOUI) Verona, Verona, 37134, Italy

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.

Primary Outcome Measures: 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 Outcome Measures: Self-esteem, The Rosenberg Self Esteem Scale (RSES) is used to assess self-esteem, a key indicator of a person's overall sense of self-worth. The scale consists of 10 items rated on a 4-point Likert scale, ranging from "strongly agree" to "strongly disagree." Higher scores reflect greater self-esteem. This outcome aims to evaluate whether the NECT intervention improves participants' self-perception and confidence from baseline (T0) to the end of the treatment (T1). Self-esteem is crucial for mental health, influencing motivation, resilience, and overall well-being, making it a vital measure of the intervention's effectiveness., From enrollment to the end of treatment at 20 weeks|Hope and expectations about the future, Hope is measured using the Beck Hopelessness Scale (BHS-9), which assesses an individual's negative expectations about the future. This 9-item self-report questionnaire asks participants to respond to statements with "true" or "false," providing a total score that indicates the level of hopelessness. Higher scores signify greater hopelessness. This outcome seeks to determine whether the NECT intervention can increase participants' sense of hope and optimism about their future, a critical factor in recovery from mental illness. Enhanced hope can lead to better coping strategies, increased motivation, and improved overall mental health., From enrollment to the end of treatment at 20 weeks|Empowerment, Empowerment is measured through the Boston University Empowerment Scale (BUES), which captures the degree to which individuals feel in control of their lives and capable of influencing their own recovery. The BUES is a 28-item self-report scale with items rated on a 4-point Likert scale. It includes five subscales: anger, optimism and control over the future, self-esteem/self-efficacy, power/perceived loss of power, and community activism and autonomy. Higher scores indicate greater empowerment. This outcome evaluates whether NECT enhances participants' feelings of empowerment, which is crucial for taking an active role in their recovery and improving their quality of life., From enrollment to the end of treatment at 20 weeks|Recovery Perception, The Recovery Assessment Scale (RAS) is used to measure participants' perceptions of their own recovery. This scale includes 20 items distributed across five factors: personal confidence and hope, willingness to ask for help, goal orientation and success, reliance on others, and not being dominated by symptoms. Participants rate their agreement with these statements on a 5-point Likert scale. Higher scores indicate a stronger sense of recovery. This outcome assesses whether the NECT intervention helps participants perceive themselves as more recovered, which is essential for their long-term mental health and well-being., From enrollment to the end of treatment at 20 weeks|Mental wellbeing, Mental well-being is assessed using the Warwick and Edinburgh Mental Wellbeing Scale (WEMWBS), which measures positive mental health through 14 items. These items are rated on a 5-point Likert scale, with higher scores indicating better mental well-being. The scale captures aspects such as positive thoughts, feelings, and psychological functioning. This outcome aims to determine if the NECT intervention can enhance participants' overall mental well-being, including their ability to function effectively in daily life and experience positive emotions, which are vital components of recovery from mental illness., From enrollment to the end of treatment at 20 weeks|Stigma as a stressor, The Stigma Stress Scale is used to evaluate the extent to which stigma is perceived as a stressor by the participants. This scale comprises two items: one measuring the perceived harm due to stigma and the other assessing the resources available to cope with it. Responses are given on a 7-point Likert scale, and the difference between the two scores represents the level of stigma-related stress. Higher scores indicate greater stress. This outcome seeks to assess whether the NECT intervention can reduce the stress associated with stigma, which is crucial for improving mental health and reducing the burden of self-stigma on daily life., From enrollment to the end of treatment at 20 weeks|Screening rate, The number of patients who meet the ISMI screening criteria compared to those who meet the inclusion and exclusion criteria., From enrollment to the end of treatment at 20 weeks|Eligible rate, The number of eligible patients who agree to participate in the study., From enrollment to the end of treatment at 20 weeks|Intervention completion rate, The number of participants who completed the intervention, the reasons for participant dropout., From enrollment to the end of treatment at 20 weeks|Exposure rate, The proportion of participants "exposed" to the intervention, defined as attending at least six sessions or completing one of the key phases: psychoeducation, cognitive restructuring, or narrative enhancement., From enrollment to the end of treatment at 20 weeks|Perceptions of Implementation Factors, In this outcome, open-ended questions will be utilized to gather detailed insights from participants and facilitators. These questions are designed to encourage respondents to express their thoughts, experiences, and opinions freely, providing a deeper understanding of the factors that may facilitate or hinder the implementation of the intervention. By using open-ended questions, the aim is to capture a wide range of perspectives and nuanced feedback that might not be fully addressed through closed-ended questions alone., From enrollment to the end of treatment at 20 weeks