Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04056767
Other study ID # 6269-19-SMC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2019
Est. completion date December 2021

Study information

Verified date August 2019
Source The Chaim Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nadav Goldental

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Heart Rate Heart Rate and HRV (Heart Rate Variability) 3 months
Primary Changes in Saturation Changes in saturation SPO2 (oxygen saturation by pulse oximetry) 3 months
Primary Changes in blood pressure Changes in Continuous Blood Pressure 3 months
Primary Changes in Pulse Pressure Changes in Pulse Pressure 3 months
Primary Changes in Respiratory rate Changes in Respiratory rate 3 months
Primary Changes in Stroke Volume Changes in Stroke Volume 3 months
Primary Changes in Systemic Vascular Resistance Changes in Systemic Vascular Resistance 3 months
Primary Changes in sweat Changes in Sweat 3 months
Primary Changes in Body Temperature Changes in Body Temperature 3 months
Primary Changes in Cardiac Output Changes in Cardiac Output 3 months
Secondary 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. 3 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03962504 - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial N/A
Completed NCT01995123 - Behavioral Activation for Smoking Cessation in PTSD N/A
Not yet recruiting NCT06278922 - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma N/A
Completed NCT04597450 - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03593772 - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD N/A
Completed NCT03429166 - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas N/A
Recruiting NCT04317820 - Deep Brain Reorienting in Post-traumatic Stress Disorder N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT03504722 - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD N/A
Completed NCT04305353 - Intensive Care Unit (ICU) Diary Project N/A
Completed NCT03113890 - McLean and Genomind Prospective Study N/A
Withdrawn NCT05173831 - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans Phase 2
Withdrawn NCT03924297 - Chilipad for Sleep and Symptoms of PTSD N/A
Completed NCT03343028 - Biomarker Establishment for Superior Treatment of PTSD
Withdrawn NCT03216356 - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD Phase 2/Phase 3
Completed NCT03158558 - Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD N/A
Completed NCT02370173 - A Non-Pharmacological Method for Enhancing Sleep in PTSD N/A
Completed NCT01955538 - The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees. Phase 3
Withdrawn NCT01957371 - Mindful Yoga Therapy for Veterans With PTSD and Pain N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A