Brief SEE FAR CBT Intervention Compared With Treatment as Usual for Adults With PTSD
13 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Meital Mashash, PhD
- Numéro de téléphone: 972-50-2888052
- E-mail: meitalm@icspc.org
Sauvegarde des contacts de l'étude
- Nom: Sivan Raz, PhD
- Numéro de téléphone: 972-54-6634301
- E-mail: sivanra@telhai.ac.il
Lieux d'étude
-
-
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Sha'ar Hanegev, Israël
- Recrutement
- The Center for Psychological Services Sha'ar Hanegev
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Contact:
- Tal Eilon
- Numéro de téléphone: 972-77-9802751
- E-mail: tale@mpsy.org.il
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
|
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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in PTSD symptoms
Délai: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
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
Délai: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
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.
|
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in depressive symptoms
Délai: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
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
Délai: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
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
Délai: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
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.
|
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
Délai: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
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.
|
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
Délai: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
|
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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Meital Mashash, PhD, Community Stress Prevention Center
- Chercheur principal: Sivan Raz, PhD, Tel Hai College
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 mars 2028
Dates d'inscription aux études
Première soumission
1 juillet 2026
Première soumission répondant aux critères de contrôle qualité
13 juillet 2026
Première publication (Réel)
17 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BRIEF-SEE-FAR-CBT-PTSD-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .