- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05031728
Cognitive Processing Therapy for Syrian Patients With PTSD (CPT4Syrians)
Cognitive Processing Therapy for the Treatment of Post-Traumatic Stress Disorder in Syrian Patients
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Cairo, Egypt, 11837
- The British University in Egypt
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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assessing change in CAPS-5 scores between three time points
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
assessing change in Beck Depression Inventory (BDI-II) scores between three time points
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Amani S Elbarazi, Ph.D., The British University in Egypt
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BritishUE20-21
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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