- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07586358
Effect of Psychoeducation on Internalized Stigma and Anxiety in Patients Receiving Electroconvulsive Therapy (PE-ECT)
THE EFFECT OF PSYCHOEDUCATION PROGRAM APPLIED TO PATIENTS RECEIVING ELECTROCONVULSIVE THERAPY ON PATIENTS' INTERNALIZED STIGMA AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY
This randomized controlled clinical trial was conducted to evaluate the effect of a psychoeducational programme on internalised stigma and anxiety levels in patients undergoing electroconvulsive therapy (ECT). The study aimed to determine whether the psychoeducational intervention reduces internalised stigma related to mental illness and improves anxiety outcomes compared to routine nursing care.
The primary questions addressed were:
Does the psychoeducational programme reduce internalised stigma in patients receiving ECT? Does the intervention decrease state and trait anxiety levels compared to routine care? Researchers compared a psychoeducational intervention group with a control group receiving routine nursing care to assess the effects of the programme on psychological outcomes.
Participants in the intervention group:
Received a six-session psychoeducational programme delivered individually over six weeks Completed pre-test and post-test assessments using standardized measurement tools
Participants in the control group received routine psychiatric nursing care and completed the same assessment measures at equivalent time points.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Meram
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Konya, Meram, Turquie (Türkiye)
- Necmettin Erbakan University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age ≥ 18 years
- Able to read and write in Turkish
- At least primary school graduate
- Diagnosed according to DSM-5 criteria with schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, obsessive-compulsive disorder, or generalized anxiety disorder
- Inpatients in a psychiatric clinic
- Receiving or scheduled to receive electroconvulsive therapy (ECT)
- No severe agitation or homicidal risk as determined by the treating psychiatrist
- Voluntary consent to participate in the study
Exclusion Criteria:
- Diagnosis of organic mental disorders (e.g., dementia, Alzheimer's disease, delirium)
- Intellectual disability
- History of alcohol or substance dependence
- Not completing at least 4 ECT sessions during the treatment process
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Psychoeducation Group (Arm 1)
Participants received a structured psychoeducational programme in addition to routine psychiatric care.
|
A structured psychoeducational programme consisting of six individual face-to-face sessions delivered over six weeks by the researcher.
The programme aimed to reduce internalised stigma and anxiety in patients undergoing electroconvulsive therapy (ECT) and included education about illness, treatment process, coping strategies, and emotional support.
|
|
Comparateur actif: Routine Care Group (Arm 2)
Participants in this arm received routine psychiatric nursing care provided in the inpatient psychiatric clinic without any additional psychoeducational intervention.
|
Standard psychiatric nursing care provided during electroconvulsive therapy (ECT) treatment.
No structured psychoeducational programme was applied.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Internalised Stigma Scale for Mental Illness (ISMI)
Délai: Baseline and 6 weeks post-intervention
|
Change in internalized stigma levels in patients undergoing electroconvulsive therapy (ECT), measured using the Internalized Stigma of Mental Illness Scale (ISMI).
Higher scores indicate higher levels of internalized stigma.
|
Baseline and 6 weeks post-intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
State Anxiety Score (STAI-State)
Délai: Baseline and 6 weeks post-intervention
|
Change in state anxiety levels in patients undergoing electroconvulsive therapy (ECT), measured using the STAI-State subscale.
Higher scores indicate higher levels of current anxiety.
|
Baseline and 6 weeks post-intervention
|
|
Trait Anxiety Score (STAI-Trait)
Délai: Baseline and 6 weeks post-intervention
|
Change in trait anxiety levels in patients undergoing electroconvulsive therapy (ECT), measured using the STAI-Trait subscale.
Higher scores indicate general anxiety tendency.
|
Baseline and 6 weeks post-intervention
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NEU-PhDHEM-2026-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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