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

Ben-Gurion University of the Negev

Status: Enrolling

Conditions: Post Traumatic Stress Disorder; PTSD

Treatments: Behavioral: Reconsolidation based short term therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06826937

SOR-24-0209

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Reconsolidation based short term therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Reconsolidation based short term therapy

WaitList

No Intervention group

Description:

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.