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NCT Number: NCT07710573

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

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Psychological Services Sha'ar Hanegev

Sha'ar Hanegev, Israel

Location status: Recruiting

Location contact

Tal Eilon

CONTACT

[email protected]

972-77-9802751

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief SEE FAR CBT Intervention

Behavioral

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.

Dynamic Psychotherapy Treatment as Usual

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Meital Mashash, PhD

CONTACT

[email protected]

972-50-2888052

Sivan Raz, PhD

CONTACT

[email protected]

972-54-6634301

Sponsors and collaborators

Lead sponsor

Community Stress Prevention Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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