NCT07710573

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Mar 2028

First Submitted

Initial submission to the registry

July 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

July 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

July 1, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

PTSDBrief SEE FAR CBTIntervention

Outcome Measures

Primary Outcomes (2)

  • Change in PTSD symptoms

    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

    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 Outcomes (7)

  • Change in depressive symptoms

    Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention

  • Change in perceived stress

    Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention

  • Change in resilience

    Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention

  • Change in somatic symptoms

    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

    Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention

  • +2 more secondary outcomes

Study Arms (2)

Brief SEE FAR CBT Intervention

EXPERIMENTAL

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.

Behavioral: Brief SEE FAR CBT Intervention

Dynamic Psychotherapy Treatment as Usual

EXPERIMENTAL

Participants in this arm will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly.

Behavioral: Dynamic Psychotherapy Treatment as Usual

Interventions

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.

Brief SEE FAR CBT Intervention

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.

Dynamic Psychotherapy Treatment as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Psychological Services Sha'ar Hanegev

Sha'ar Hanegev, Israel

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Meital Mashash, PhD

    Community Stress Prevention Center

    PRINCIPAL INVESTIGATOR
  • Sivan Raz, PhD

    Tel Hai College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meital Mashash, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to one of two parallel groups. One group will receive the Brief SEE FAR CBT protocol followed by completion of the full 12-session SEE FAR CBT protocol. The comparison group will receive dynamic psychotherapy as treatment as usual.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 17, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

July 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations