Short-Term Recall and Reprocess Therapy for Post Traumatic Stress Disorder (PTSD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBen-Gurion University of the Negev
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• 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.
Trial design
Design model
Crossover
Treatments tested in this trial
Reconsolidation based short term therapy
BehavioralThis is a behavioral intervention that uses imaginal and in vivo exposure in daily meetings.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Reconsolidation based short term therapyExperimental treatment 1 intervention
Group B: WaitListNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in PTSD symptoms (PCL-5)
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
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 outcomes
1
Improved sleep
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
6 weeks total. One week before the beginning of the treatment, during treatment and up to 30 days follow-up.2
Depressive symptoms
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.
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))Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ben-Gurion University of the Negev
Lead sponsor
Soroka University Medical Center
Collaborator
Soroka Hospital,Beer Sheva,Israel
Collaborator
Source ClinicalTrials.gov