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

NCT ID: NCT06826937

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2030-12-31

Brief 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.

Conditions

PTSD; Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Reconsolidation based short term therapy

Intervention Type: BEHAVIORAL

This is a behavioral intervention that uses imaginal and in vivo exposure in daily meetings.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reconsolidation based short term therapy

This is a behavioral intervention that uses imaginal and in vivo exposure in daily meetings.

Intervention Type: BEHAVIORAL

Other Intervention Names

Short Term Recall and Reprocessing Therapy

Eligibility Criteria

Inclusion Criteria

• • 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.

Exclusion Criteria

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

• Patients with a history of antidepressant-induced hypomania or mania as determined by open-ended psychiatric interview.
• Current, ongoing serious suicidal risk as assessed by evaluating.
• Moderate severity or greater Substance Use Disorder (excepting Alcohol Use Disorder) during the 3 months prior to randomization, as determined by the SCID.
• History of traumatic brain injury (TBI) with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days may be considered if the trauma occurred more than 1 year ago, and no more than minimal symptoms have 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 a result of ECG screening or laboratory studies.
• Any history indicating learning disability or mental retardation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: collaborator

Soroka Hospital,Beer Sheva,Israel

UNKNOWN

Sponsor Role: collaborator

Ben-Gurion University of the Negev

OTHER

Sponsor Role: lead

Responsible Party

Or Duek

Or Duek, PhD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ben Gurion University of the Negev

Beersheba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Or Duek, Ph.D

Role: CONTACT

ord@bgu.ac.il

+972-507606547

Facility Contacts

Or Duek, Ph.D

Role: primary

ord@bgu.ac.il

+972-507606547

Other Identifiers

SOR-24-0209

Identifier Type: -

Identifier Source: org_study_id