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Promoting Recovery by Overcoming Self-stigma in Mental Health Disorders With a Narrative Enhancement and Cognitive Therapy (NECT) Group Intervention

3 agosto 2026 aggiornato da: Louise Penzenstadler

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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

106

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Canton of Geneva
      • Geneva, Canton of Geneva, Svizzera, 1205

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in personal recovery measured by the Recovery Assessment Scale
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in personal recovery at follow-up
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

30 settembre 2028

Completamento dello studio (Stimato)

30 settembre 2029

Date di iscrizione allo studio

Primo inviato

24 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 luglio 2026

Primo Inserito (Effettivo)

30 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

A decision regarding the sharing of de-identified individual participant data has not yet been made. Data sharing will depend on applicable ethical and data-protection requirements, participant consent, and approval by the study investigators and relevant institutions.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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