Changes in Digital Phenotype During PE Therapy

Nadav Goldental

Status: Unknown

Conditions: PTSD

Study type: Observational

Funder types: Other

Identifiers

NCT04056767

6269-19-SMC

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

100 participants in 2 patient groups

Imaginal PE

Writing PE