NCT03000478

Brief Summary

This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure Therapy in adult patients with combat related PTSD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

December 20, 2016

Last Update Submit

February 15, 2018

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

  • PTSD symptoms

    PTSD as measured by the CAPS

    6 months post treatment

Study Arms (2)

Prolonged Exposure

ACTIVE COMPARATOR

12 sessions of PE as per protocol

Behavioral: Prolonged Exposure

VRET

EXPERIMENTAL

12 sessions of Virtual Reality Exposure Therapy

Behavioral: Virtual Reality Exposure Therapy

Interventions

Prolonged ExposureBEHAVIORAL
Prolonged Exposure
Virtual Reality Exposure TherapyBEHAVIORAL
VRET

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • combat related PTSD; Hebrew first language

You may not qualify if:

  • suicidality, other psychiatric diagnosis requiring treatment, concurrent treatment,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bar Ilan University

Ramat Gan, 52900, Israel

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Sara Freedman, PhD

CONTACT

544704636sarafreedman@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sara Freedman

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 22, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)