Changes in Digital Phenotype During PE Therapy

Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04056767

Enrollment

100

Registered

2019-08-14

Start date

2019-09-30

Completion date

2021-12-31

Last updated

2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* PTSD diagnosis * Proper ability to give informed consent

Exclusion criteria

* Active psychotic or suicidal symptoms * Severe dissociative symptoms * A traumatic brain injury (TBI) diagnosis * Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Changes in Cardiac Output	3 months	Changes in Cardiac Output
Changes in Heart Rate	3 months	Heart Rate and HRV (Heart Rate Variability)
Changes in Saturation	3 months	Changes in saturation SPO2 (oxygen saturation by pulse oximetry)
Changes in blood pressure	3 months	Changes in Continuous Blood Pressure
Changes in Pulse Pressure	3 months	Changes in Pulse Pressure
Changes in Respiratory rate	3 months	Changes in Respiratory rate
Changes in Stroke Volume	3 months	Changes in Stroke Volume
Changes in Systemic Vascular Resistance	3 months	Changes in Systemic Vascular Resistance
Changes in sweat	3 months	Changes in Sweat
Changes in Body Temperature	3 months	Changes in Body Temperature

Secondary

Measure	Time frame	Description
Correlation between changes in digital phenotype (multiple measures)	3 months	Correlation between changes in digital phenotype during the sessions and the clinical improvement according to the psychiatric evaluation and questionnaires.

Outcome results