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Changes in Digital Phenotype During PE Therapy

Sponsor
Nadav Goldental (Other)
Overall Status
Unknown status
CT.gov ID
NCT04056767
Collaborator
(none)
100
Enrollment
27
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Measurement of Changes in the Digital Phenotype During Prolonged Exposure Therapy for PTSD Using Smart Watch
    Anticipated Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Aug 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Imaginal PE
    Writing PE

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Heart Rate [3 months]

      Heart Rate and HRV (Heart Rate Variability)

    2. Changes in Saturation [3 months]

      Changes in saturation SPO2 (oxygen saturation by pulse oximetry)

    3. Changes in blood pressure [3 months]

      Changes in Continuous Blood Pressure

    4. Changes in Pulse Pressure [3 months]

      Changes in Pulse Pressure

    5. Changes in Respiratory rate [3 months]

      Changes in Respiratory rate

    6. Changes in Stroke Volume [3 months]

      Changes in Stroke Volume

    7. Changes in Systemic Vascular Resistance [3 months]

      Changes in Systemic Vascular Resistance

    8. Changes in sweat [3 months]

      Changes in Sweat

    9. Changes in Body Temperature [3 months]

      Changes in Body Temperature

    10. Changes in Cardiac Output [3 months]

      Changes in Cardiac Output

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nadav Goldental

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nadav Goldental, Principal investigator, The Chaim Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT04056767
    Other Study ID Numbers:
    • 6269-19-SMC
    First Posted:
    Aug 14, 2019
    Last Update Posted:
    Aug 14, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 14, 2019