- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07672613
EMDR Flash Group Protocol for Earthquake Survivors (FlashGP-EQ)
Preliminary Effects of an Early EMDR Flash Group Intervention on Traumatic Stress, Anxiety, and Depressive Symptoms Among Earthquake Survivors: A Pilot Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The Kahramanmaraş earthquakes of February 2023 affected millions of people and were associated with substantial psychological distress, including posttraumatic stress, anxiety, and depressive symptoms. Early psychological interventions may help reduce acute distress and improve posttraumatic outcomes following disaster exposure.
This pilot randomized controlled trial was conducted approximately one month after the earthquakes. Adults affected by the disaster were recruited online and randomized in a 1:1 ratio to either the EMDR Flash Group Protocol intervention or a waitlist control condition. The intervention was delivered online via Zoom by trained mental health professionals using a standardized protocol consisting of two group sessions.
The primary objective was to evaluate the preliminary effects of the EMDR Flash Group Protocol on posttraumatic stress symptoms. Secondary objectives were to evaluate changes in depression, anxiety, and stress symptoms. Outcomes were assessed using self-report measures at baseline and at 3-month follow-up.
This study was conducted as a pilot trial to evaluate the feasibility and preliminary effectiveness of the intervention following a large-scale natural disaster.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Istanbul
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Istanbul, Istanbul, Turquie (Türkiye)
- Istanbul Galata University
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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 or older
- Present in the earthquake-affected region during the 2023 Kahramanmaraş earthquakes
- Directly experienced the earthquake or were affected through disaster-related exposure
- Ability to participate in online sessions
- Access to the necessary technological equipment and internet connection
- Ability to provide informed consent
Exclusion Criteria:
- Intellectual disability
- Current or past psychotic disorder (e.g., schizophrenia)
- Bipolar disorder
- History of severe head trauma
- Inability to participate in the online intervention format
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: EMDR Flash Group Protocol
Participants received the online EMDR Flash Group Protocol delivered by trained mental health professionals.
The intervention consisted of two group sessions lasting approximately 60 to 90 minutes and was conducted via Zoom approximately one month after the 2023 Kahramanmaraş earthquakes.
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The EMDR Flash Group Protocol was delivered online via Zoom by trained mental health professionals.
The intervention consisted of two group sessions lasting approximately 60-90 minutes and was administered approximately one month after the 2023 Kahramanmaraş earthquakes.
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Aucune intervention: Waitlist Control
Participants assigned to the waitlist control group did not receive the EMDR Flash Group Protocol during the study period and completed the same assessment schedule as the intervention group.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in PTSD Symptoms (PCL-5 Total Score)
Délai: Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Change in posttraumatic stress symptom severity measured by the PTSD Checklist for DSM-5 (PCL-5) total score from baseline to 3-month follow-up.
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Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Depression Symptoms (DASS-21 Depression)
Délai: Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Change in depression symptom severity measured by the Depression Anxiety Stress Scale-21 (DASS-21) Depression subscale from baseline to 3-month follow-up.
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Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Change in Anxiety Symptoms (DASS-21 Anxiety)
Délai: Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Change in anxiety symptom severity measured by the DASS-21 Anxiety subscale from baseline to 3-month follow-up.
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Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Change in Stress Symptoms (DASS-21 Stress)
Délai: Assessed at baseline (pre-intervention) and at 3-month follow-up.
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Change in depression symptom severity measured by the Depression Anxiety Stress Scale-21 (DASS-21) Depression subscale from baseline to 3-month follow-up.
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Assessed at baseline (pre-intervention) and at 3-month follow-up.
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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
- EMDRFLASHGP-2023-RCT
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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