- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07735481
Promoting Recovery by Overcoming Self-stigma in Mental Health Disorders With a Narrative Enhancement and Cognitive Therapy (NECT) Group Intervention
Promoting Recovery by Overcoming Self-stigma in Mental Health Disorders With a Narrative Enhancement and Cognitive Therapy (NECT) Group Intervention - A Randomized Controlled Trial and Qualitative Study
This study will evaluate whether Narrative Enhancement and Cognitive Therapy (NECT) can promote recovery among adults living with severe mental health disorders, including substance use disorders. NECT is a structured group intervention that combines education about stigma, cognitive techniques to challenge internalized negative beliefs, and narrative exercises that help participants develop a broader identity beyond their diagnosis.
Approximately 106 adults receiving outpatient or day-hospital psychiatric care at Geneva University Hospitals will be randomly assigned to receive either usual care plus 12 weekly NECT sessions or usual care plus 12 comparison group sessions that do not specifically address self-stigma or recovery. The study will examine whether NECT improves recovery after the intervention and whether any benefits are maintained over time.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Self-stigma occurs when people internalize negative societal stereotypes about mental illness. It can contribute to shame, reduced self-esteem, hopelessness, social withdrawal, lower treatment engagement, and difficulties pursuing personal goals. Although recovery-oriented mental health care increasingly emphasizes empowerment, resilience, social inclusion, and quality of life, interventions specifically targeting self-stigma are not yet routinely available. This is particularly relevant for people with substance use disorders, who may experience strong moral judgment and stigmatizing attitudes.
Narrative Enhancement and Cognitive Therapy is a manualized, recovery-oriented group intervention developed to reduce self-stigma. The programme combines psychoeducation about stigma and common misconceptions, cognitive restructuring of negative beliefs about oneself, and narrative exercises in which participants reflect on and share personal experiences. Its purpose is to help participants develop a more integrated understanding of themselves that is not defined solely by mental illness. Previous studies have reported beneficial effects in people with psychotic disorders, but evidence remains limited for other psychiatric populations and for people with substance use disorders. The French-language programme has not yet been evaluated in routine clinical practice.
The study will use a prospective, multicentre, randomized controlled design with an additional qualitative component. Approximately 106 adults with psychiatric disorders will be recruited from three specialized outpatient or day-hospital settings within the Department of Psychiatry at Geneva University Hospitals. Participants will be randomly allocated in a 1:1 ratio to an intervention or control condition. Randomization will be stratified by participating centre.
Participants assigned to the intervention condition will continue their usual psychiatric care and attend 12 weekly NECT group sessions. Participants assigned to the control condition will continue their usual care and attend 12 weekly group sessions that do not include specific psychotherapeutic or psychoeducational content addressing self-stigma or recovery. The comparison sessions may focus, for example, on participants' weekly activities.
NECT will be delivered in groups of approximately eight participants. Each 90-minute session will be facilitated by two trained co-facilitators, including a mental health professional and a peer practitioner. The programme includes an introductory session, psychoeducation, cognitive restructuring, narrative enhancement, and a concluding session. Participants who miss a session may be offered an individual make-up session to review the content and reduce the risk of discontinuing the programme.
The main objective is to determine whether participation in NECT improves personal recovery compared with the control condition. The study will also examine whether any changes are maintained approximately six months after the intervention and whether NECT influences self-stigma, empowerment, quality of life, self-esteem, self-compassion, psychological flexibility, psychiatric symptoms, and substance use.
In addition to the quantitative evaluation, participants who receive NECT may take part in semi-structured interviews after the intervention. These interviews will explore how participants experienced the programme, what they found useful, and how changes in self-stigma may contribute to recovery. The qualitative findings will complement the quantitative results and help inform the possible future implementation of NECT in routine psychiatric and addiction services.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Louise Penzenstadéer, MD
- Número de telefone: +41223725750
- E-mail: louise.penzenstadler@hug.ch
Estude backup de contato
- Nome: Hélène Richard-Lépouriel, MD
- Número de telefone: +41223054511
- E-mail: helene.richard-lepouriel@hug.ch
Locais de estudo
-
-
Canton of Geneva
-
Geneva, Canton of Geneva, Suíça, 1205
- Geneva University Hospital
-
Contato:
- Louise Penzenstadler, MD
- Número de telefone: +41223725750
- E-mail: louise.penzenstadler@hug.ch
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Written informed consent
- DSM-5 psychiatric diagnosis within F10-F48, F60-F69, or F90, including substance use disorders
- Receiving outpatient or day-hospital treatment
- Diagnosed or in treatment for at least 12 months
- Clinically stable for at least 3 months, with stable pharmacological treatment during this period
- Clinical Global Impressions-Severity score below 6
Exclusion Criteria:
- Participation in another program likely to affect social functioning or self-stigma, such as social cognitive remediation or social skills training
- Acute psychiatric episode with a Clinical Global Impressions-Severity score above 6
- Medical emergency or immediate life-threatening situation at inclusion
- Unable to provide informed consent
- Comorbid intellectual disability
- Receiving care under constraint or deprived of liberty by judicial order Insufficient ability to speak and read French
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: NECT
Treatment as usual plus 12 weekly 90-minute NECT group sessions combining psychoeducation, cognitive restructuring, and narrative exercises to reduce self-stigma and support recovery.
|
NECT is a manualized group intervention comprising 12 weekly 90-minute sessions delivered to groups of approximately eight participants.
It combines psychoeducation about stigma and self-stigma, cognitive restructuring of internalized negative beliefs, and narrative exercises that help participants develop a more integrated identity beyond mental illness.
Sessions are co-facilitated by a trained mental health professional and a peer practitioner.
Individual make-up sessions may be offered for missed sessions.
|
|
Comparador Ativo: Control Group
Treatment as usual plus 12 weekly group sessions without specific psychotherapeutic or psychoeducational content targeting self-stigma or recovery
|
Twelve weekly group sessions in which participants discuss topics such as their weekly activities, without specific psychotherapeutic or psychoeducational content targeting self-stigma or recovery.
Treatment as usual continues throughout.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in personal recovery measured by the Recovery Assessment Scale
Prazo: Baseline to post-intervention, approximately 12 weeks.
|
Personal recovery will be assessed using the Recovery Assessment Scale (RAS).
The total score ranges up to 205, with higher scores indicating greater recovery.
An increase of at least 14 points is considered clinically meaningful.
|
Baseline to post-intervention, approximately 12 weeks.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in personal recovery at follow-up
Prazo: Baseline to approximately 6 months after the intervention.
|
Personal recovery measured with the Recovery Assessment Scale.
The total score ranges up to 205, with higher scores indicating greater recovery.
An increase of at least 14 points is considered clinically meaningful.
|
Baseline to approximately 6 months after the intervention.
|
|
Change in self-stigma
Prazo: Baseline, post-intervention, and approximately 6 months after the intervention.
|
Self-stigma measured with the 29-item Internalized Stigma of Mental Illness Scale.
Items are rated from 1 to 4 and combined into a mean total score ranging from 29 to 116.
The stigma-resistance items are reverse-scored.
Higher scores indicate greater internalized stigma and therefore a worse outcome.
|
Baseline, post-intervention, and approximately 6 months after the intervention.
|
|
Change in empowerment
Prazo: Baseline, post-intervention, and approximately 6 months after the intervention.
|
Sense of empowerment measured with the 28-item Empowerment Scale.
an overall mean score will be calculated, ranging from 28 to 112.
Higher scores indicate greater perceived empowerment and therefore a better outcome.
|
Baseline, post-intervention, and approximately 6 months after the intervention.
|
|
Change in quality of life
Prazo: Baseline, post-intervention, and approximately 6 months after the intervention.
|
Subjective quality of life measured with the 26-item WHO Quality of Life-BREF.
Scores will be calculated separately for the physical health, psychological health, social relationships, and environment domains and transformed to a scale ranging from 0 to 100.
Higher scores indicate better quality of life and therefore a better outcome.
|
Baseline, post-intervention, and approximately 6 months after the intervention.
|
|
Change in self-compassion
Prazo: Baseline, post-intervention, and approximately 6 months after the intervention.
|
Self-compassion measured with the 26-item Self-Compassion Scale.
The total score is ranging from 26 to 130. Higher scores indicate greater self-compassion and therefore a better outcome.
|
Baseline, post-intervention, and approximately 6 months after the intervention.
|
|
Change in psychological flexibility
Prazo: Baseline, post-intervention, and approximately 6 months after the intervention.
|
Psychological flexibility measured with the 10-item Acceptance and Action Questionnaire-II.
Items are rated from 1 to 7 and summed to produce a total score ranging from 10 to 70.
Higher scores indicate greater psychological inflexibility and experiential avoidance and therefore a worse outcome.
|
Baseline, post-intervention, and approximately 6 months after the intervention.
|
|
Change in psychiatric symptoms
Prazo: Baseline, post-intervention, and approximately 6 months after the intervention.
|
Psychiatric symptoms measured with the 23-item DSM-5 Cross-Cutting Symptom Measure, Levels 1.
It assesses 13 psychiatric symptom domains.
Each item is rated from 0 to 4, and the highest item score within each domain is used as the domain score.
Each domain score therefore ranges from 0 to 4. Higher scores indicate greater symptom frequency or severity and therefore a worse outcome.
There is no single total score for this measure.
The scores should be reported by domain.
|
Baseline, post-intervention, and approximately 6 months after the intervention.
|
|
Change in substance use
Prazo: Baseline, post-intervention at approximately 12 weeks, and 6 months after the intervention.
|
Substance use will be assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Level 2-Substance Use.
Each substance-specific item is rated from 0 to 4, where 0 indicates no use and 4 indicates use nearly every day during the previous two weeks.
Higher item scores indicate more frequent substance use and therefore a worse outcome.
Individual substance items will be interpreted separately rather than as a single overall scale score.
|
Baseline, post-intervention at approximately 12 weeks, and 6 months after the intervention.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- in preparation
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .