Clinical trial NCT06567145: A Group-based Treatment for Self-stigma in People With Mental Disorders in North-east Italy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stigma
Mental Disorders
Self-stigma
Keywords: stigma
narrative enhancement cognitive therapy
narrative therapy
cognitive therapy
mental disorders
self-stigma
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: BACKGROUND Population surveys indicate that people generally hold distorted views and negative stereotypes about individuals suffering from mental disorders. For example, 60% of the population believes that patients with mental disorders are aggressive or violent, and 50% believe they are incapable of working. Research has also found that most individuals with mental disorders are aware of the presence of these stereotypes in society, and over 70% expect to be treated unjustly by others because of their condition. Additionally, 60-70% of patients with mental disorders believe that most people would refuse to have someone with a mental disorder as a friend, neighbor, colleague, or partner. While some individuals with mental disorders may react to these stereotypes with indifference or anger, most end up accepting these stereotypes as true, internalizing them and attributing them to themselves; this phenomenon is known as internalized stigma or self-stigma. One of the largest studies in this field estimated that 41% of individuals with schizophrenia spectrum disorders experience high levels of self-stigma. Other studies have reported similar rates. The literature has found that self-stigma is associated with worse recovery outcomes. A recent meta-analysis reports significant correlations between self-stigma and a lack of hope, self-esteem, and self-efficacy, poorer subjective quality of life, greater symptom severity, and lower treatment adherence. Self-stigma can be both a consequence and a cause of negative outcomes. When self-stigma plays a causal role, it can become a target for treatment. Yanos and colleagues proposed the illness identity model which provides a set of detailed and testable hypotheses regarding the potential causal role that self-stigma plays in influencing recovery outcomes in individuals with mental disorders. This model suggests that when identity is influenced by self-stigma, individuals believe that recovery is not possible, reducing hope (i.e., expectations about one future) and self-esteem. Despair and low self-esteem, in turn, increase the risk of suicide, reduce social interaction, lead to the use of passive coping strategies for symptoms, and reduce treatment adherence. As patients use avoidant coping strategies, they may also lose their jobs. Finally, avoidant coping, social isolation, and reduced social functioning can increase the severity of psychotic symptoms. Empirical support for this model comes from the findings of two studies conducted by different research groups. Building on the evidence of the role that self-stigma plays in recovery processes, Narrative Enhancement and Cognitive Therapy (NECT) was developed as a treatment protocol aimed at reducing self-stigma in individuals with mental disorders. NECT is a structured group treatment that combines psychoeducation (to help participants challenge stigmatizing beliefs about mental illness and recovery with empirical and scientific data), cognitive restructuring (aimed at teaching skills to modify negative beliefs about oneself related to stigma), and narrative enhancement (designed to help participants improve their ability to integrate themes like trust and self-worth into their narratives). To date, five studies have tested the effectiveness of NECT. The first, conducted in the United States with a small group of 39 patients, failed to highlight significant effects of NECT on self-stigma, likely due to the small sample size; however, the intervention was found to be feasible and well-tolerated by participants. A study conducted in Israel with 119 patients showed that participation in the NECT program was associated with significant improvements in self-esteem, quality of life, and hope. Similarly, a randomized controlled trial with a 6-month follow-up conducted in Gothenburg, Sweden, found that the NECT intervention was associated with significant improvements in self-esteem and self-stigma, and that these improvements were maintained at six months. A subsequent randomized controlled study conducted in the United States with 170 patients with schizophrenia spectrum disorders demonstrated that NECT could produce significant improvements in self-stigma and other variables, including avoidant coping, compared to the supportive control intervention. Finally, a randomized controlled trial implemented in Taiwan showed more significant results from NECT in improving self-esteem and reducing perceived discrimination compared to the control intervention. These studies demonstrate that NECT's effectiveness is supported by robust empirical evidence, qualifying it as an evidence-based intervention and suggesting its large-scale implementation. Unfortunately, in Italy, interventions against self-stigma in individuals with mental disorders are not regularly provided. Where anti-self-stigma interventions are offered, they are generally not based on solid evidence of effectiveness. This delay is due to the unavailability of manualized interventions, such as NECT, in our language. Moreover, the anti-self-stigma interventions published in the literature have so far been tested in geographical contexts and within healthcare organizations very different from those in our country. Therefore, it is unclear how these interventions, if made available in Italian, could be applicable within our healthcare settings.

OBJECTIVES The objectives of this study are: (1) to evaluate the effectiveness of this approach in the clinical routine of mental health centers; (2) to test the feasibility of the new Italian version of the NECT treatment in patients who seek care at mental health centers in a large area of north-eastern Italy. Overall, this project will enhance knowledge of optimal treatments for patients with mental disorders burdened by high self-stigma, with the aim of improving their recovery outcomes. The study is a pragmatic, multicenter, randomized controlled trial with two parallel arms: intervention group and control group.

INTERVENTIONS The intervention group will receive Narrative Enhancement and Cognitive Therapy (NECT), a structured group therapy aimed at reducing self-stigma in individuals with severe mental disorders. NECT, originally developed by Philip Yanos and colleagues, has been adapted into Italian for this study and consists of 20 sessions divided into five parts: orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. Each part is designed to help participants reflect on their experiences, challenge self-stigmatizing beliefs, and foster a new, positive identity. The control group will continue with their usual care, which typically involves a combination of pharmacological treatment and psychosocial interventions provided by public mental health services. The study will systematically collect information about the care received by participants during the trial.

STUDY DURATION AND RANDOMIZATION PROCEDURE NECT sessions during approximately one hour, structured into an introduction, a central discussion, and a conclusion. The NECT intervention is considered an add-on treatment, meaning participants will continue receiving their standard care in addition to the group therapy. The control group will continue with their usual treatment, which may include medication, symptom management, and psychiatric rehabilitation. Staff involved in delivering the NECT intervention will undergo specific training to ensure consistent and effective implementation.

Treatment fidelity will be monitored through audio recordings of selected sessions, evaluated using the NECT Fidelity Scale.

The study also includes a feasibility assessment, measuring participant engagement, session completion rates, and feedback from both participants and facilitators to identify factors that may impact the implementation of NECT in clinical settings.

The study is designed to be completed over 12 months. It begins with protocol approval, followed by a two-month recruitment phase to enroll eligible participants. Once recruitment is complete, a five-month intervention phase will take place, during which participants will undergo the NECT treatment. The final five months are allocated for data entry, analysis, and the preparation of results for publication.

The study involves 26 community mental health centers (CMHCs) across the Veneto region, the Trento province, and the city of Bolzano.

The randomization process is crucial for ensuring the validity of the trial. Each CMHC will recruit 16 patients, for a total of 416 participants. They will be randomly assigned to either the NECT intervention group or a control group, maintaining a 1:1 allocation ratio.

This stratified randomization by CMHC ensures that the unique characteristics of each center are accounted for, contributing to the robustness of the study's findings. The randomization will be carried out using specialized software to ensure fairness and consistency across all centers.

Eligibility criteria: Inclusion Criteria:

1. Participants must be 18 years or older.
2. 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.
3. Participants must be outpatients with clinical stability for at least 3 months, with no changes in pharmacological treatment during this period.
4. Participants must have sufficient knowledge of written and spoken Italian.
5. Participants must score above 1 on the ISMI (Internalized Stigma of Mental Illness) scale, indicating at least moderate levels of self-stigma.

Exclusion Criteria:

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

Primary outcomes:
measure: Differences in the level of self-stigma
timeFrame: From enrollment to the end of treatment at 20 weeks
Secondary outcomes:
measure: Self-esteem
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Hope and expectations about the future
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Empowerment
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Recovery Perception
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Mental wellbeing
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Stigma as a stressor
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Screening rate
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Eligible rate
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Intervention completion rate
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Exposure rate
timeFrame: From enrollment to the end of treatment at 20 weeks
measure: Perceptions of Implementation Factors
timeFrame: From enrollment to the end of treatment at 20 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata (AOUI) Verona
Study officials:
References:
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