Enhancing Exposure Therapy for Post Traumatic Stress Disorder (PTSD): Virtual Reality and Imaginal Exposure With a Cognitive Enhancer

NCT ID: NCT01352637

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2018-09-30

Brief Summary

The purpose of this study is to test the differences between four active treatment conditions for combat-related Post Traumatic Stress Disorder (PTSD): virtual reality exposure therapy (VRE) or prolonged imaginal exposure therapy (PE), both with DCS or placebo, as well as to examine predictors for PTSD and response to treatment in active duty military personnel, veterans, and civilians who served in Iraq and Afghanistan.

Detailed Description

Post Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop following exposure to traumatic events and includes symptoms of re-experiencing the trauma, such as through nightmares and flashbacks, avoidance and numbing, and physical hyperarousal. PTSD has been estimated to affect 10-20% of returning Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) veterans. The most effective intervention found for PTSD is exposure therapy, which can be delivered in different formats, e. g. via virtual reality (VR) and as imaginal exposure. The goal of this study is to test the difference between 4 study conditions: virtual reality exposure therapy (VRE) or prolonged imaginal exposure therapy (PE), both combined with an antibiotic drug, DCS (active pill vs. placebo). D-Cycloserine (DCS), a drug that has been FDA approved for over 20 years, has been hypothesized to enhance the therapeutic effects of exposure therapy.). A secondary purpose of this study is to examine predictors for PTSD and response to PTSD intervention in active duty military personnel, veterans, and civilians who served in Iraq/Afghanistan. Psychophysiological factors (e.g. heart rate, blood pressure) and/or a genetic polymorphism (BDNF Val66Met) obtained from a saliva sample will be examined.

The two primary co-aims are

1. to examine the effects of DCS versus placebo (PLA) augmentation of exposure therapy on PTSD symptoms, and

2. to examine the relative efficacy of virtual reality enhanced exposure therapy (VRE) and exposure therapy (PE) on PTSD symptoms.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo + Prolonged Imaginal Exposure

Drug: Placebo (sugar pill) + Prolonged Imaginal Exposure (PE) PTSD treatment

Group Type: PLACEBO_COMPARATOR

Placebo + Prolonged Imaginal Exposure

Intervention Type: DRUG

Placebo (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure

Placebo + VR exposure

Drug: Placebo (sugar pill) + Virtual Reality Exposure (VR) PTSD treatment

Group Type: PLACEBO_COMPARATOR

Placebo (sugar pill) + Virtual Reality Exposure

Intervention Type: DRUG

Placebo (taken once a week on the day of the therapy session) + Virtual Reality Exposure

DCS + Prolonged Imaginal Exposure

Drug: 50mg DCS (D-Cycloserine ) + Prolonged Imaginal Exposure (PE) PTSD treatment

Group Type: ACTIVE_COMPARATOR

DCS (D-Cycloserine ) + Prolonged Imaginal Exposure

Intervention Type: DRUG

50mg DCS (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure

DCS+VR exposure

Drug: 50mg DCS (D-Cycloserine ) + Virtual Reality Exposure (VR) PTSD treatment

Group Type: ACTIVE_COMPARATOR

DCS (D-Cycloserine ) + Virtual Reality Exposure

Intervention Type: DRUG

50mg DCS (taken once a week on the day of the therapy session) + Virtual Reality Exposure

Interventions

DCS (D-Cycloserine ) + Prolonged Imaginal Exposure

50mg DCS (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure

Intervention Type: DRUG

DCS (D-Cycloserine ) + Virtual Reality Exposure

50mg DCS (taken once a week on the day of the therapy session) + Virtual Reality Exposure

Intervention Type: DRUG

Placebo + Prolonged Imaginal Exposure

Placebo (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure

Intervention Type: DRUG

Placebo (sugar pill) + Virtual Reality Exposure

Placebo (taken once a week on the day of the therapy session) + Virtual Reality Exposure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of OEF-OIF (Operations Enduring Freedom or Iraqi Freedom) Combat Related PTSD;

2. Female participants of childbearing potential must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide) during the course of the study, or to remain abstinent from sex, to ensure they do not become pregnant during the course of the study;

3. Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments;

4. Participants must be literate in English;

5. Patients must be medically healthy and willing to take the study drug;

6. VRE stimuli available must be consistent with subject's trauma.

Exclusion Criteria

1. Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder;

2. Participation in a clinical trial during the previous 3 months;

3. Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, CNS tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment;

4. Patients who in the investigator's judgment pose a current suicidal or homicidal risk;

5. Alcohol, medication, or illegal substance dependence within the past 90 days;

6. Treatment with any other concomitant medication with primarily CNS activity, or treatment with any medication that the PI judges not acceptable for this study;

7. history of seizures;

8. Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: collaborator

VA Long Beach Healthcare System

FED

Sponsor Role: collaborator

National Intrepid Center of Excellence

FED

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JoAnn Difede, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Barbara Rothbaum, Ph.D., ABPP

Role: PRINCIPAL_INVESTIGATOR

Emory University

Skip Rizzo, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

VA Long Beach Healthcare System

Long Beach, California, United States

University of Southern California

Los Angeles, California, United States

Emory University

Atlanta, Georgia, United States

Walter Reed Army Medical Center/National Intrepid Center of Excellence (NICoE)

Bethesda, Maryland, United States

Weill Cornell Medical College

New York, New York, United States

Countries

United States

References

Difede J, Rothbaum BO, Rizzo AA, Wyka K, Spielman L, Reist C, Roy MJ, Jovanovic T, Norrholm SD, Cukor J, Olden M, Glatt CE, Lee FS. Enhancing exposure therapy for posttraumatic stress disorder (PTSD): a randomized clinical trial of virtual reality and imaginal exposure with a cognitive enhancer. Transl Psychiatry. 2022 Jul 27;12(1):299. doi: 10.1038/s41398-022-02066-x.

Reference Type: DERIVED

PMID: 35896533 (View on PubMed)

Difede J, Rothbaum BO, Rizzo AA, Wyka K, Spielman L, Jovanovic T, Reist C, Roy MJ, Norrholm SD, Glatt C, Lee F. Enhanced exposure therapy for combat-related Posttraumatic Stress Disorder (PTSD): Study protocol for a randomized controlled trial. Contemp Clin Trials. 2019 Dec;87:105857. doi: 10.1016/j.cct.2019.105857. Epub 2019 Oct 24.

Reference Type: DERIVED

PMID: 31669451 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.patss.com

Related Info

Other Identifiers

1005011047

Identifier Type: -

Identifier Source: org_study_id