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- Klinische proef NCT07720674
SEE FAR CBT Intervention for Adults With PTSD
17 juli 2026 bijgewerkt door: Community Stress Prevention Center
A Clinical Study Evaluating the Effects of a SEE FAR CBT Intervention on Psychological Outcomes in Adults With Posttraumatic Stress Disorder.
This single-arm clinical intervention study evaluates a 12-session SEE FAR CBT intervention for adults aged 18 years and older with posttraumatic stress disorder (PTSD).
SEE FAR CBT is a trauma-focused cognitive-behavioral treatment approach.
Participants will complete self-report psychological questionnaires at three time points: baseline, after completion of the intervention, and at a 3-month follow-up.
The study aims to examine changes in PTSD symptoms and related psychological outcomes over the course of treatment and follow-up.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Meital Mashash, PhD
- Telefoonnummer: 972-50-2888052
- E-mail: meitalm@icspc.org
Studie Contact Back-up
- Naam: Sivan Raz, PhD
- Telefoonnummer: 972-54-6634301
- E-mail: sivanra@telhai.ac.il
Studie Locaties
-
-
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Kiryat Shmona, Israël
- Werving
- Community Stress Prevention Center
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Contact:
- Meital Mashash, PhD
- Telefoonnummer: 972-50-2888052
- E-mail: meitalm@icspc.org
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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 or above
- Able to provide informed consent
- Willing and able to participate in 12 weekly individual therapy sessions and complete study questionnaires at baseline, post-intervention, and 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 enrolment.
- Initiation of psychiatric medication less than 3 months prior to enrolment.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: SEE FAR CBT Intervention
Participants in this single-arm study will receive 12 therapeutic sessions of SEE FAR CBT for PTSD, delivered approximately once weekly.
|
SEE FAR CBT is a trauma-focused cognitive-behavioral treatment approach.
Participants will receive 12 therapeutic sessions delivered approximately once weekly as a structured psychological intervention for PTSD.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in PTSD symptoms
Tijdsspanne: Baseline, 12-16 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 post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
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Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
|
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Change in anxiety symptoms
Tijdsspanne: Baseline, 12-16 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 post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
|
Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in depressive symptoms
Tijdsspanne: Baseline, 12-16 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 from baseline to post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
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Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
|
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Change in perceived stress
Tijdsspanne: Baseline, 12-16 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 from baseline to post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
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Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
|
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Change in resilience
Tijdsspanne: Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
|
Connor-Davidson Resilience Scale (CD-RISC-10).
Resilience 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 from baseline to post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
|
Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
|
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Change in somatic symptoms
Tijdsspanne: Baseline, 12-16 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 from baseline to post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
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Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
|
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Change in trauma-related use of imagination and coping
Tijdsspanne: Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
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Fantastic Reality Ability Measurement (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 from baseline to post-intervention, from baseline to 3-month follow-up, and from post-intervention to 3-month follow-up.
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Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Meital Mashash, PhD, Community Stress Prevention Center
- Hoofdonderzoeker: Sivan Raz, PhD, Tel Hai College
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
1 december 2027
Studie voltooiing (Geschat)
1 maart 2028
Studieregistratiedata
Eerst ingediend
1 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 juli 2026
Eerst geplaatst (Werkelijk)
22 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
17 juli 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SEE-FAR-CBT-PTSD-NORTH-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .