- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Istanbul
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Istanbul, Istanbul, Tyrkiet (Türkiye)
- Istanbul Galata University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
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.
|
|
Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in PTSD Symptoms (PCL-5 Total Score)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Depression Symptoms (DASS-21 Depression)
Tidsramme: Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
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)
Tidsramme: Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
Change in anxiety symptom severity measured by the DASS-21 Anxiety subscale from baseline to 3-month follow-up.
|
Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
|
Change in Stress Symptoms (DASS-21 Stress)
Tidsramme: Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
Change in depression symptom severity measured by the Depression Anxiety Stress Scale-21 (DASS-21) Depression subscale from baseline to 3-month follow-up.
|
Assessed at baseline (pre-intervention) and at 3-month follow-up.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EMDRFLASHGP-2023-RCT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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