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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Istanbul
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Istanbul, Istanbul, Turkije (Türkiye)
- Istanbul Galata University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in PTSD Symptoms (PCL-5 Total Score)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Depression Symptoms (DASS-21 Depression)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EMDRFLASHGP-2023-RCT
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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