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

Official title

Short Term Recall and Reprocess Therapy for PTSD

Overview

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.

Interventions

• Behavioral Reconsolidation based short term therapy
  This is a behavioral intervention that uses imaginal and in vivo exposure in daily meetings.

Primary outcome measures

• Changes in PTSD symptoms (PCL-5) [Time frame: At screening, at the end of treatment (i.e., 7 days following the initiation of the treatment), at 30 days, at 90 days and up to 5 years follow-up (bi-annualy, i.e., every six months))]

Secondary outcome measures (2)

• Improved sleep [Time frame: 6 weeks total. One week before the beginning of the treatment, during treatment and up to 30 days follow-up.]
• Depressive symptoms [Time frame: At screening, at the end of treatment (i.e., 7 days following the initiation of the treatment), at 30 days, at 90 days and up to 5 years follow-up (bi-annualy, i.e., every six months))]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Israel · 1 center

• Ben Gurion University of the Negev — Beersheba

Identifiers

NCT: NCT06826937 · SOR-24-0209

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗