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NCT Number: NCT06826937

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ben Gurion University of the Negev

Beersheba, 8410501, Israel

Location status: Recruiting

Location contact

Hadar Shalev, M.D.

PRINCIPAL_INVESTIGATOR

Or Duek, Ph.D

CONTACT

[email protected]

+972-507606547

Or Duek, Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reconsolidation based short term therapy

Behavioral

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

Other names: Short Term Recall and Reprocessing Therapy

Primary outcomes

  1. 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))

    Assessing changes in PTSD symptoms measured using the PTSD Checklist 5 (PCL-5). PCL uses a 5 point Likert scale ranging from "not at all" (0) to "extremely" (4). Score ranges between 0-80, with higher score means higher severity

Secondary outcomes

  1. Improved sleep

    Time frame: 6 weeks total. One week before the beginning of the treatment, during treatment and up to 30 days follow-up.

    Sleep will be measured using both a self-report questionnaire and a Garmin Vivosmart 5 watch. This will include total sleep per day, average weekly (hours), and REM/total sleep time ratio. All will be measured using the wearable watch.

  2. 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))

    Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II). Participants respond to each item using a 4-point Likert scale, ranging from 0 (not present) to 3 (severe), which allows for the quantification of symptom severity. Higher score corresponds to higher severity of depressive symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Or Duek, Ph.D

CONTACT

[email protected]

+972-507606547

Sponsors and collaborators

Lead sponsor

Ben-Gurion University of the Negev

Other

Collaborators

  • Soroka Hospital,Beer Sheva,Israel
  • Soroka University Medical Center

Registry information

Official study title

Short Term Recall and Reprocess Therapy for PTSD

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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