PTSDNCT06826937
Short-Term Recall and Reprocess Therapy for Post Traumatic Stress Disorder (PTSD)
A study testing Reconsolidation based short term therapy in people with PTSD and Post Traumatic Stress Disorder, run by Ben-Gurion University of the Negev at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder
- What is being tested?
- Reconsolidation based short term therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Jan 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Ben Gurion University of the Negev
Beersheba, 8410501
Or Duek, Ph.D, +972-507606547, ord@bgu.ac.il
Or Duek, Ph.D
About this study
Official title: Short Term Recall and Reprocess Therapy for 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.
Read more
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.
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Being tested
- Reconsolidation based short term therapy
- Keywords
- Prolonged Exposure, Massed Therapy, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconsolidation based short term therapyBehavioural
Also called Short Term Recall and Reprocessing Therapy
This is a behavioral intervention that uses imaginal and in vivo exposure in daily meetings.
| Study group | Role | What they receive |
|---|---|---|
| Reconsolidation based short term therapy | Experimental | 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. Receives: Behavioral: Reconsolidation based short term therapy |
| WaitList | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (2)
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.
Measured: 6 weeks total. One week before the beginning of the treatment, during treatment and up to 30 days follow-up.
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.
Measured: 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))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start25 Jan 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- People will be assigned to intervention or waiting list groups. The waiting list will be crossed over 3 months into the study (after the 90 follow-up point)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ben-Gurion University of the Negev
- Sponsor type
- University, hospital or other
- Collaborators
- Soroka University Medical Center, Soroka Hospital,Beer Sheva,Israel
- Responsible party
- Principal investigator, Or Duek, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826937
- Sponsor's protocol ID
- SOR-24-0209
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD is planned to be shared following a specific request and after identification.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Recall and Reprocess Therapy for PTSD
- ClinicalTrials.gov ID
- NCT06826937
- Acronym / sponsor ID
- SOR-24-0209
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Keywords
- Prolonged Exposure, Massed Therapy, PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ben-Gurion University of the NegevUniversity, hospital or other
- Collaborators
- Soroka University Medical Center, Soroka Hospital,Beer Sheva,Israel
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- People will be assigned to intervention or waiting list groups. The waiting list will be crossed over 3 months into the study (after the 90 follow-up point)
| Arm | Type | Receives |
|---|---|---|
| Reconsolidation based short term therapy | Experimental | Behavioral: Reconsolidation based short term therapyThis 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. |
| WaitList | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Diagnosis of PTSD with a score of 25 or higher (i.e. severe PTSD) on the Clinician- Administered PTSD Scale (CAPS-5) at screening.
Key exclusion criteria (8 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reconsolidation based short term therapyAlso: Short Term Recall and Reprocessing TherapyThis is a behavioral intervention that uses imaginal and in vivo exposure in daily meetings. | Behavioural | Reconsolidation based short term therapy |
Primary outcome
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
2 secondary outcomes
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))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided. IPD is planned to be shared following a specific request and after identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconsolidation based short term therapy in people with PTSD and Post Traumatic Stress Disorder, run by Ben-Gurion University of the Negev at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Or Duek, Ph.D (+972-507606547, ord@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025; AzTrials last refreshed its copy on 2 Nov 2026.