Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567145
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
A Group-based Treatment for Self-stigma in People With Mental Disorders in North-east Italy
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NECT-ITA
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
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 ie 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 NECTs 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 11 allocation ratio
This stratified randomization by CMHC ensures that the unique characteristics of each center are accounted for contributing to the robustness of the studys findings The randomization will be carried out using specialized software to ensure fairness and consistency across all centers
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 11 allocation ratio
This stratified randomization by CMHC ensures that the unique characteristics of each center are accounted for contributing to the robustness of the studys findings The randomization will be carried out using specialized software to ensure fairness and consistency across all centers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None