Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Brief SEE FAR CBT Intervention Compared With Treatment as Usual for Adults With PTSD

13. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Israel
      • Sha'ar Hanegev, Israel
        • Rekruttering
        • The Center for Psychological Services Sha'ar Hanegev
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: Brief SEE FAR CBT Intervention
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.
Eksperimentell: Dynamic Psychotherapy Treatment as Usual
Participants in this arm will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.
Atferdsmessig: Dynamic Psychotherapy Treatment as Usual
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in PTSD symptoms
Tidsramme: 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.
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
Change in anxiety symptoms
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in depressive symptoms
Tidsramme: 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.
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
Change in perceived stress
Tidsramme: 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.
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
Change in resilience
Tidsramme: 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
Change in somatic symptoms
Tidsramme: 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
Change in trauma-related use of imagination and coping
Tidsramme: 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.
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
Change in sleep quality
Tidsramme: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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.
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
Change in PTSD-related functional impairment
Tidsramme: Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
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.
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Community Stress Prevention Center

Samarbeidspartnere

Tel Hai College
The Center for Psychological Services Sha'ar Hanegev

Etterforskere

  • Hovedetterforsker: Meital Mashash, PhD, Community Stress Prevention Center
  • Hovedetterforsker: Sivan Raz, PhD, Tel Hai College

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

1. juli 2026

Først innsendt som oppfylte QC-kriteriene

13. juli 2026

Først lagt ut (Faktiske)

17. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BRIEF-SEE-FAR-CBT-PTSD-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere