PTSDNCT04056767
Changes in Digital Phenotype During PE Therapy
An observational study of PTSD, run by Nadav Goldental.
Trial summary
PTSD is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. Prolonged Exposure (PE) therapy is a widely used protocol considered highly affective among individuals diagnosed with PTSD. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- PTSD
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (aged 18 and over) participants diagnosed with PTSD and undergoing PE therapy; 50 using imaginal PE and 50 using writing PE.
Who may be able to join
- PTSD diagnosis
- Proper ability to give informed consent
Who cannot join
- Active psychotic or suicidal symptoms
- Severe dissociative symptoms
- A traumatic brain injury (TBI) diagnosis
- Pregnancy
About this study
Official title: Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch
PTSD is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. Prolonged Exposure (PE) therapy is a widely used protocol considered highly affective among individuals diagnosed with PTSD.
The current study is a non-interventional observational study, aimed at measuring changes in the digital phenotype of participants with PTSD during and following PE therapy. Physiological data will be collected using wearable sensors during the sessions, and participants will be assessed using questionnaires and psychiatric assessments before and after the completion of their imaginal or writing based PE therapy (10-15 sessions).
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Imaginal PE | Not described | |
| Writing PE | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Heart Rate
Heart Rate and HRV (Heart Rate Variability)
Measured: 3 months
Changes in Saturation
Changes in saturation SPO2 (oxygen saturation by pulse oximetry)
Measured: 3 months
Changes in blood pressure
Changes in Continuous Blood Pressure
Measured: 3 months
Changes in Pulse Pressure
Changes in Pulse Pressure
Measured: 3 months
Changes in Respiratory rate
Changes in Respiratory rate
Measured: 3 months
Changes in Stroke Volume
Changes in Stroke Volume
Measured: 3 months
Changes in Systemic Vascular Resistance
Changes in Systemic Vascular Resistance
Measured: 3 months
Changes in sweat
Changes in Sweat
Measured: 3 months
Changes in Body Temperature
Changes in Body Temperature
Measured: 3 months
Changes in Cardiac Output
Changes in Cardiac Output
Measured: 3 months
Secondary outcomes (1)
Correlation between changes in digital phenotype (multiple measures)
Correlation between changes in digital phenotype during the sessions and the clinical improvement according to the psychiatric evaluation and questionnaires.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadav Goldental
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadav Goldental, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056767
- Sponsor's protocol ID
- 6269-19-SMC
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch
- ClinicalTrials.gov ID
- NCT04056767
- Acronym / sponsor ID
- 6269-19-SMC
- Conditions
- PTSD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nadav GoldentalUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Aug 2019 (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.
PTSD is characterized by physiological changes, some of which are thought to be chronic, while others are observed in response to stressogenic stimuli. Prolonged Exposure (PE) therapy is a widely used protocol considered highly affective among individuals diagnosed with PTSD.
The current study is a non-interventional observational study, aimed at measuring changes in the digital phenotype of participants with PTSD during and following PE therapy. Physiological data will be collected using wearable sensors during the sessions, and participants will be assessed using questionnaires and psychiatric assessments before and after the completion of their imaginal or writing based PE therapy (10-15 sessions).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaginal PE | – | – |
| Writing PE | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (aged 18 and over) participants diagnosed with PTSD and undergoing PE therapy; 50 using imaginal PE and 50 using writing PE.
Key inclusion criteria (2 listed)
- PTSD diagnosis
- Proper ability to give informed consent
Key exclusion criteria (4 listed)
- Active psychotic or suicidal symptoms
- Severe dissociative symptoms
- A traumatic brain injury (TBI) diagnosis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Heart Rate
Time frame: 3 months
Heart Rate and HRV (Heart Rate Variability)
Changes in Saturation
Time frame: 3 months
Changes in saturation SPO2 (oxygen saturation by pulse oximetry)
Changes in blood pressure
Time frame: 3 months
Changes in Continuous Blood Pressure
Changes in Pulse Pressure
Time frame: 3 months
Changes in Pulse Pressure
Changes in Respiratory rate
Time frame: 3 months
Changes in Respiratory rate
Changes in Stroke Volume
Time frame: 3 months
Changes in Stroke Volume
Changes in Systemic Vascular Resistance
Time frame: 3 months
Changes in Systemic Vascular Resistance
Changes in sweat
Time frame: 3 months
Changes in Sweat
Changes in Body Temperature
Time frame: 3 months
Changes in Body Temperature
Changes in Cardiac Output
Time frame: 3 months
Changes in Cardiac Output
1 secondary outcome
Correlation between changes in digital phenotype (multiple measures)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by Nadav Goldental.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Heart Rate (time frame: 3 months). The study lists 10 primary outcomes in all. 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 Aug 2019.