- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07710573
Brief SEE FAR CBT Intervention Compared With Treatment as Usual for Adults With PTSD
July 13, 2026 updated by: 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meital Mashash, PhD
- Phone Number: 972-50-2888052
- Email: meitalm@icspc.org
Study Contact Backup
- Name: Sivan Raz, PhD
- Phone Number: 972-54-6634301
- Email: sivanra@telhai.ac.il
Study Locations
-
-
-
Sha'ar Hanegev, Israel
- Recruiting
- The Center for Psychological Services Sha'ar Hanegev
-
Contact:
- Tal Eilon
- Phone Number: 972-77-9802751
- Email: tale@mpsy.org.il
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Experimental: Dynamic Psychotherapy Treatment as Usual
Participants in this arm will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PTSD symptoms
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depressive symptoms
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Meital Mashash, PhD, Community Stress Prevention Center
- Principal Investigator: Sivan Raz, PhD, Tel Hai College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
July 1, 2026
First Submitted That Met QC Criteria
July 13, 2026
First Posted (Actual)
July 17, 2026
Study Record Updates
Last Update Posted (Actual)
July 17, 2026
Last Update Submitted That Met QC Criteria
July 13, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRIEF-SEE-FAR-CBT-PTSD-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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