Health TrialsbyHealthPanel

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

ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCommunity Stress Prevention Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

PTSD symptoms, defined as a PCL-5 score of 30-60

Hebrew-speaking

Able to provide informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Brief SEE FAR CBT InterventionExperimental treatment 1 intervention
Group B: Dynamic Psychotherapy Treatment as UsualExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
2

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.

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

Secondary outcomes

1

Change in depressive symptoms

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.

Time frame
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
2

Change in perceived stress

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.

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

Change in resilience

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.

Time frame
Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention
4

Change in somatic symptoms

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.

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The Center for Psychological Services Sha'ar HanegevRecruiting Sha'ar HanegevIsraelIsrael

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Community Stress Prevention Center

Lead sponsor

Tel Hai College

Collaborator

The Center for Psychological Services Sha'ar Hanegev

Collaborator

Source ClinicalTrials.gov
Apply now