- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05031728
Cognitive Processing Therapy for Syrian Patients With PTSD (CPT4Syrians)
Cognitive Processing Therapy for the Treatment of Post-Traumatic Stress Disorder in Syrian Patients
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Cairo, Egitto, 11837
- The British university in Egypt
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria Their nationalities are Syrians
- age older than 18 years and younger than 65,
- patients meeting current diagnostic criteria for PTSD as defined in DSM-5
- have a good knowledge of English-language (reading, writing, and comprehension) because all assessments and therapy materials were in English
Exclusion Criteria
- having mental retardation
- having schizophrenia (or any other psychotic disorders).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: CPT Group
Cognitive Processing Therapy (CPT) is employed.
Each patient will attend 12 individual sessions with the therapist.
The sessions will be on the weekly basis.
The standard manual of CPT (Resick et al., 2016) is going to be employed.
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Cognitive processing therapy (CPT) (Resick et al., 2016) which is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of Post-Traumatic Stress Disorder (PTSD) that may have developed after experiencing a variety of traumatic events including child abuse, emotional abuse, combat, rape war, and natural disasters.
CPT helps patients learn how to challenge and modify unhelpful beliefs related to the trauma and emotional pain.
In so doing, the client creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
assessing change in CAPS-5 scores between three time points
Lasso di tempo: baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Clinician-Administered PTSD Scale (CAPS-5; Weathers et al., 2015) is currently the gold- standard assessment for PTSD and is used to assess PTSD's symptoms at pre-intervention, immediately post- intervention, and 12-month after the intervention.
This 30-item structured interview was developed by staff at the U.S. Department of Veterans Affairs National Center for PTSD.
The interview can generally be administered in 45-60 minutes.
Each question in CAPS asks about both the frequency and the severity of each PTSD symptom.
These questions are split into categories.
Each criterion has several questions, and scores for each criterion are added up at the end.
The CAPS-5 has demonstrated strong psychometric properties (Weathers, et al., 2018).
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baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
assessing change in Beck Depression Inventory (BDI-II) scores between three time points
Lasso di tempo: baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Beck Depression Inventory (BDI-II): was used to evaluate the change in the severity of depressive symptoms between three time points.
BDI-II is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1996).
The BDI takes approximately 10 minutes to complete.
Depression levels were defined as follows: minimal range = 0- 13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29- 63.
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baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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assessing change in Beck Anxiety Inventory (BAI) scores between three time points
Lasso di tempo: baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Beck Anxiety Inventory (BAI): was used to evaluate the change in the severity of anxiety severity between three time points. BAI was developed by Dr. Aaron T. Beck and it is a brief measure of anxiety with a focus on somatic symptoms of anxiety such as nervousness, dizziness, inability to relax (Beck et al., 1988). It has a total of 21 items that takes approximately 10-15 minutes to complete. Answers are on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The values for each item are summed yielding an overall or total score for all 21 symptoms that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 -25 as "Moderate", and 26 - 63 as "Severe". |
baseline (pre-intervention), posttreatment (immediately after the intervention), 12-months after the intervention
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Amani S Elbarazi, Ph.D., The British university in Egypt
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BritishUE20-21
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
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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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