Changes in Digital Phenotype During PE Therapy
Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch
1 other identifier
observational
100
0 countries
N/A
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 14, 2019
August 1, 2019
1.9 years
August 6, 2019
August 13, 2019
Conditions
Outcome Measures
Primary Outcomes (10)
Changes in Heart Rate
Heart Rate and HRV (Heart Rate Variability)
3 months
Changes in Saturation
Changes in saturation SPO2 (oxygen saturation by pulse oximetry)
3 months
Changes in blood pressure
Changes in Continuous Blood Pressure
3 months
Changes in Pulse Pressure
Changes in Pulse Pressure
3 months
Changes in Respiratory rate
Changes in Respiratory rate
3 months
Changes in Stroke Volume
Changes in Stroke Volume
3 months
Changes in Systemic Vascular Resistance
Changes in Systemic Vascular Resistance
3 months
Changes in sweat
Changes in Sweat
3 months
Changes in Body Temperature
Changes in Body Temperature
3 months
Changes in Cardiac Output
Changes in Cardiac Output
3 months
Secondary Outcomes (1)
Correlation between changes in digital phenotype (multiple measures)
3 months
Study Arms (2)
Imaginal PE
Writing PE
Eligibility Criteria
Adult (aged 18 and over) participants diagnosed with PTSD and undergoing PE therapy; 50 using imaginal PE and 50 using writing PE.
You may qualify if:
- PTSD diagnosis
- Proper ability to give informed consent
You may not qualify if:
- Active psychotic or suicidal symptoms
- Severe dissociative symptoms
- A traumatic brain injury (TBI) diagnosis
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nadav Goldentallead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 14, 2019
Study Start
September 1, 2019
Primary Completion
August 1, 2021
Study Completion
December 1, 2021
Last Updated
August 14, 2019
Record last verified: 2019-08