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| Name | Class |
|---|---|
| Tel Hai College | OTHER |
| The Center for Psychological Services Sha'ar Hanegev | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Dynamic Psychotherapy Treatment as Usual | Experimental | Participants in this arm will receive dynamic psychotherapy as treatment as usual, delivered approximately once weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention |
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Inclusion Criteria
Participants must meet all of the following criteria:
Participants will be excluded if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meital Mashash, PhD | Contact | 972-50-2888052 | meitalm@icspc.org | |
| Sivan Raz, PhD | Contact | 972-54-6634301 | sivanra@telhai.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Meital Mashash, PhD | Community Stress Prevention Center | Principal Investigator |
| Sivan Raz, PhD | Tel Hai College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Psychological Services Sha'ar Hanegev | Recruiting | Sha'ar Hanegev | Israel |
Individual participant data will not be shared due to the sensitive clinical nature of the data and participant privacy considerations.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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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.
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| 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. |
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| 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. | Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention |
| 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. | Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention |
| 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. | 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 | 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 | 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 | 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. | Baseline, 6 weeks after baseline, 12 weeks after baseline, and 3 months after completion of the intervention |