Short-Term Recall and Reprocess Therapy for Post Traumatic Stress Disorder (PTSD)

Last updated: February 9, 2025
Sponsor: Ben-Gurion University of the Negev
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Reconsolidation based short term therapy

Clinical Study ID

NCT06826937
SOR-24-0209
  • Ages 18-70
  • All Genders

Study Summary

The goal of this clinical trial is to learn if a short-term behavioral intervention, based on imaginal and in-vivo exposure and psychodynamic reprocessing, works on alleviating Post-Traumatic Stress Disorder (PTSD) symptoms in adults. The trial will also learn about patterns of recovery and relapse by following the patients for up to five years. The main questions it aims to answer are:

Does the reconsolidation-based short-term intervention help alleviate PTSD symptoms? How is it affecting other mental health issues (such as depression, sleep problems, and general functioning)? What is the long-term effect of the intervention? Researchers will compare this behavioral intervention to a waiting list, for up to three months. People on the waiting list will then be able to cross over to the treatment arm as well.

Participants will:

Be screened by a clinical psychologist Take the week-long intensive behavioral intervention (psychotherapy) Followed at the end of treatment (day 7), at 30 and 90 days, and every 6 months, up to five years.

Wearable devices will be used during the week before treatment, during treatment, and up to 30 days following the end of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Diagnosis of PTSD with a score of 25 or higher (i.e. severe PTSD) on theClinician- Administered PTSD Scale (CAPS-5) at screening.

  • Subjects on FDA-approved antidepressants, trazodone, atypical neuroleptic,prazosin, or clonidine may enter the study if they have been on a stabletreatment, as determined by the study clinician, for at least 4 weeks prior torandomization. Following randomization, small changes to doses may be allowableat the PI's discretion.

  • Able to provide written informed consent.

  • Able to read and write English/Hebrew.

Exclusion

Exclusion Criteria:

  • • Patients with a diagnostic history of bipolar disorder, borderline personalitydisorder, obsessive-compulsive disorder, schizophrenia or schizoaffective disorderor currently exhibiting psychotic features as determined by the clinical interview;dementia or suspicion thereof, are excluded. Other DSM Axis I disorders arepermitted as long as they are not considered primary disorders.

  • Patients with a history of antidepressant-induced hypomania or mania asdetermined by open-ended psychiatric interview.

  • Current, ongoing serious suicidal risk as assessed by evaluating.

  • Moderate severity or greater Substance Use Disorder (excepting Alcohol UseDisorder) during the 3 months prior to randomization, as determined by theSCID.

  • History of traumatic brain injury (TBI) with loss of consciousness for morethan 24 hours or posttraumatic amnesia for more than 7 days may be consideredif the trauma occurred more than 1 year ago, and no more than minimal symptomshave persisted over the past year.

  • Any significant history of neurological illness or heart disease.

  • Any signs of major medical or neurological illness on examination or as aresult of ECG screening or laboratory studies.

  • Any history indicating learning disability or mental retardation.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Reconsolidation based short term therapy
Phase:
Study Start date:
January 25, 2025
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Ben Gurion University of the Negev

    Beer-Sheva, 8410501
    Israel

    Active - Recruiting

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