- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07720674
SEE FAR CBT Intervention for Adults With PTSD
17 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Meital Mashash, PhD
- Telefonnummer: 972-50-2888052
- E-post: meitalm@icspc.org
Studera Kontakt Backup
- Namn: Sivan Raz, PhD
- Telefonnummer: 972-54-6634301
- E-post: sivanra@telhai.ac.il
Studieorter
-
-
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Kiryat Shmona, Israel
- Rekrytering
- Community Stress Prevention Center
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Kontakt:
- Meital Mashash, PhD
- Telefonnummer: 972-50-2888052
- E-post: meitalm@icspc.org
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in PTSD symptoms
Tidsram: 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
Tidsram: Baseline, 12-16 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 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in depressive symptoms
Tidsram: 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
Tidsram: Baseline, 12-16 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 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
Tidsram: Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
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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.
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Baseline, 12-16 weeks after baseline, and 3 months after completion of the intervention
|
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Change in somatic symptoms
Tidsram: Baseline, 12-16 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 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Meital Mashash, PhD, Community Stress Prevention Center
- Huvudutredare: Sivan Raz, PhD, Tel Hai College
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
1 mars 2028
Studieregistreringsdatum
Först inskickad
1 juli 2026
Först inskickad som uppfyllde QC-kriterierna
17 juli 2026
Första postat (Faktisk)
22 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juli 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SEE-FAR-CBT-PTSD-NORTH-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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