A Group-based Treatment for Self-stigma in People With Mental Disorders in North-east Italy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversita di Verona
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Narrative Enhancement Cognitive Therapy (NECT)
BehavioralThe 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.
Treatment groups
416 Participants
are divided into 2 treatment groupsGroup A: Narrative Enhancement and Cognitive Therapy (NECT)Experimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
From enrollment to the end of treatment at 20 weeksSecondary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 20 weeks2
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.
Time frame
From enrollment to the end of treatment at 20 weeks3
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.
Time frame
From enrollment to the end of treatment at 20 weeks4
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.
Time frame
From enrollment to the end of treatment at 20 weeksSponsors and contacts
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Source ClinicalTrials.gov