Brief SEE FAR CBT Intervention Compared With Treatment as Usual for Adults With PTSD
13 lipca 2026 zaktualizowane przez: Community Stress Prevention Center
A Clinical Study Evaluating the Effects of a Brief SEE FAR CBT Intervention Compared With Dynamic Psychotherapy Treatment as Usual on Psychological Outcomes in Adults With Posttraumatic Stress Disorder
This clinical intervention study evaluates a newly developed Brief SEE FAR CBT protocol for adults aged 18 years and older with posttraumatic stress disorder (PTSD), compared with dynamic psychotherapy treatment as usual.
Participants in the Brief SEE FAR CBT group will receive 6 focused sessions emphasizing intrusive PTSD symptoms and will then continue to complete the full 12-session SEE FAR CBT protocol.
Participants in the control group will receive dynamic psychotherapy as treatment as usual.
Psychological outcomes will be assessed using self-report questionnaires at four time points: baseline, after 6 sessions, after 12 sessions, and at a 3-month follow-up.
The study aims to examine changes in PTSD symptoms, anxiety, depression, perceived stress, resilience, somatic symptoms, sleep quality, and related psychological outcomes over the course of treatment and follow-up.
Przegląd badań
Status
Rekrutacyjny
Warunki
Typ studiów
Interwencyjne
Zapisy (Szacowany)
60
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Meital Mashash, PhD
- Numer telefonu: 972-50-2888052
- E-mail: meitalm@icspc.org
Kopia zapasowa kontaktu do badania
- Nazwa: Sivan Raz, PhD
- Numer telefonu: 972-54-6634301
- E-mail: sivanra@telhai.ac.il
Lokalizacje studiów
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Sha'ar Hanegev, Izrael
- Rekrutacyjny
- The Center for Psychological Services Sha'ar Hanegev
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Kontakt:
- Tal Eilon
- Numer telefonu: 972-77-9802751
- E-mail: tale@mpsy.org.il
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria
Participants must meet all of the following criteria:
- Age 18 years or older
- PTSD symptoms, defined as a PCL-5 score of 30-60
- Hebrew-speaking
- Able to provide informed consent
- Willing and able to participate in the assigned psychological intervention and complete study questionnaires at baseline, after 6 sessions, after 12 sessions, and at 3-month follow-up Exclusion Criteria
Participants will be excluded if they meet any of the following criteria:
- Pregnancy at the time of enrollment, due to the potential influence of pregnancy and childbirth during the treatment or follow-up period on psychological outcomes
- Currently receiving psychotherapy of any type that began less than 3 months prior to enrollment
- Initiation of psychiatric medication less than 3 months prior to enrollment
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Brief SEE FAR CBT Intervention
Participants in this arm will receive 6 focused sessions of Brief SEE FAR CBT, a newly developed protocol emphasizing intrusive PTSD symptoms.
After completing the 6 focused sessions, participants will continue to complete the full 12-session SEE FAR CBT protocol.
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Brief SEE FAR CBT is a focused trauma-oriented cognitive-behavioral intervention based on the SEE FAR CBT approach.
The brief protocol consists of 6 sessions delivered approximately once weekly, with emphasis on intrusive PTSD symptoms.
Participants will then continue treatment to complete the full 12-session SEE FAR CBT protocol.
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Eksperymentalny: Dynamic Psychotherapy Treatment as Usual
Participants in this arm will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.
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Participants will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.
This comparison condition represents the standard psychological treatment provided to participants in this clinical setting.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in PTSD symptoms
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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PTSD Checklist for DSM-5 (PCL-5) PTSD symptoms will be assessed using the PCL-5.
Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Change in PCL-5 total score will be examined from baseline to after 6 sessions, from baseline to after 12 sessions, from baseline to 3-month follow-up, from after 6 sessions to after 12 sessions, and from after 12 sessions to 3-month follow-up.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in anxiety symptoms
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Generalized Anxiety Disorder-7 (GAD-7) Anxiety symptoms will be assessed using the GAD-7.
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Change in GAD-7 total score will be examined from baseline to after 6 sessions, from baseline to after 12 sessions, from baseline to 3-month follow-up, from after 6 sessions to after 12 sessions, and from after 12 sessions to 3-month follow-up.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in depressive symptoms
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Patient Health Questionnaire-9 (PHQ-9) Depressive symptoms will be assessed using the PHQ-9.
Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Change in PHQ-9 total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in perceived stress
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Perceived Stress Scale (PSS) Perceived stress will be assessed using the PSS.
Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Change in PSS total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in resilience
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Connor-Davidson Resilience Scale (CD-RISC) esilience will be assessed using the CD-RISC.
Total scores range from 0 to 40, with higher scores indicating greater resilience.
Change in CD-RISC total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in somatic symptoms
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Patient Health Questionnaire-15 (PHQ-15) Somatic symptoms will be assessed using the PHQ-15.
Total scores range from 0 to 30, with higher scores indicating greater somatic symptom severity.
Change in PHQ-15 total score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in trauma-related use of imagination and coping
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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FRAME Trauma-related use of imagination and coping will be assessed using the FRAME questionnaire.
The FRAME is a 21-item measure of fantastic reality ability, defined as the capacity to use imagination in response to stress or trauma.
Items are rated on a 1-7 Likert scale, and mean scores range from 1 to 7, with higher scores indicating greater fantastic reality ability.
Change in FRAME score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in sleep quality
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Brief Version of the Pittsburgh Sleep Quality Index Sleep quality will be assessed using the brief version of the Pittsburgh Sleep Quality Index.
Change in sleep quality score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Change in PTSD-related functional impairment
Ramy czasowe: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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PTSD-related functional impairment will be assessed using the functional impairment section of the Posttraumatic Diagnostic Scale (PDS).
This section includes 7 items assessing the extent to which PTSD-related problems interfered with work, relationships, leisure activities, family relationships, sex life, general life satisfaction, and overall functioning during the past two weeks.
Items are rated from 0 to 4, and total scores range from 0 to 28, with higher scores indicating greater functional impairment.
Change in functional impairment score will be examined across the four study assessment points.
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Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Meital Mashash, PhD, Community Stress Prevention Center
- Główny śledczy: Sivan Raz, PhD, Tel Hai College
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 lipca 2026
Zakończenie podstawowe (Szacowany)
1 grudnia 2027
Ukończenie studiów (Szacowany)
1 marca 2028
Daty rejestracji na studia
Pierwszy przesłany
1 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 lipca 2026
Pierwszy wysłany (Rzeczywisty)
17 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
17 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
13 lipca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BRIEF-SEE-FAR-CBT-PTSD-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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