Short Term Recall and Reprocess Therapy for PTSD

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• • Diagnosis of PTSD with a score of 25 or higher (i.e. severe PTSD) on the Clinician- 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 stable treatment, as determined by the study clinician, for at least 4 weeks prior to randomization. Following randomization, small changes to doses may be allowable at the PI's discretion.

⁃ Able to provide written informed consent.

⁃ Able to read and write English/Hebrew.

Locations
Other Locations
Israel
Ben Gurion University of the Negev
RECRUITING
Beersheba
Contact Information
Primary
Or Duek, Ph.D
ord@bgu.ac.il
+972-507606547
Time Frame
Start Date: 2025-01-25
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 160
Treatments
Experimental: Reconsolidation based short term therapy
This will include an intensive week-long intervention (see Duek et al., 2023). Following the first meeting with the therapist, in which life history will be taken, patients will meet on a daily basis for five consecutive days. During these days, the patient will undergo imaginal exposure followed by processing of the traumatic event. Later this day, the patient will undergo in-vivo exposure with a member of the research team.~The patient will be followed up for up to five years.
No_intervention: WaitList
Patients who will be randomized to this arm will start with no intervention (following the screening procedure). They will be monitored at the screening at 7, 30, and 90 days. After the last follow-up, crossover to the active group will be offered.
Related Therapeutic Areas
Sponsors
Leads: Ben-Gurion University of the Negev
Collaborators: Soroka Hospital,Beer Sheva,Israel, Soroka University Medical Center

This content was sourced from clinicaltrials.gov