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
Or Duek, Ph.D
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06826937
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Beersheba, 8410501, Israel
Location status: Recruiting
Hadar Shalev, M.D.
PRINCIPAL_INVESTIGATOR
Or Duek, Ph.D
CONTACT
Or Duek, Ph.D
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is a behavioral intervention that uses imaginal and in vivo exposure in daily meetings.
Other names: Short Term Recall and Reprocessing Therapy
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
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.
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.
Contact information is provided by the study sponsor or research team.
Ben-Gurion University of the Negev
Other
Short Term Recall and Reprocess Therapy for PTSD
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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