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

NCT01352637 | Completed Phase 3 Results DMC

• 1 other identifier: 1005011047
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 5

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Traumatic Event; Trauma Survivor; Exposure Therapy; PTSD DCS; Virtual Reality Exposure; Veteran; Combat-related PTSD

Outcome Measures

Primary Outcomes (1)

• CAPS-IV at the End of Treatment

  Clinician Administered PTSD Scale (CAPS) for the DSM-IV \[34\]. The CAPS-IV is a structured clinical interview designed to assess the 17 DSM-IV PTSD symptoms. CAPS-IV provides categorical ratings of diagnostic status as well as a quantitative index of symptom severity. The CAPS total severity score is based on response to the 17 items that assess the frequency and intensity of current PTSD symptoms. Symptom severity is assessed separately for past month and past week time frames. CAPS-IV range is 0-136, higher scores mean a worse outcome.

  after weekly treatment session 9 (at posttreatment assessment)

Study Arms (4)

Placebo + Prolonged Imaginal Exposure

PLACEBO COMPARATOR

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

Drug: Placebo + Prolonged Imaginal Exposure

Placebo + VR exposure

PLACEBO COMPARATOR

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

Drug: Placebo (sugar pill) + Virtual Reality Exposure

DCS + Prolonged Imaginal Exposure

ACTIVE COMPARATOR

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

Drug: DCS (D-Cycloserine ) + Prolonged Imaginal Exposure

DCS+VR exposure

ACTIVE COMPARATOR

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

Drug: DCS (D-Cycloserine ) + Virtual Reality Exposure

Interventions

DCS (D-Cycloserine ) + Prolonged Imaginal Exposure DRUG

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

DCS + Prolonged Imaginal Exposure

DCS (D-Cycloserine ) + Virtual Reality Exposure DRUG

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

DCS+VR exposure

Placebo + Prolonged Imaginal Exposure DRUG

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

Placebo + Prolonged Imaginal Exposure

Placebo (sugar pill) + Virtual Reality Exposure DRUG

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

Placebo + VR exposure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of OEF-OIF (Operations Enduring Freedom or Iraqi Freedom) Combat Related PTSD;
• 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;
• Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments;
• Participants must be literate in English;
• Patients must be medically healthy and willing to take the study drug;
• VRE stimuli available must be consistent with subject's trauma.

You may not qualify if:

• Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder;
• Participation in a clinical trial during the previous 3 months;
• 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;
• Patients who in the investigator's judgment pose a current suicidal or homicidal risk;
• Alcohol, medication, or illegal substance dependence within the past 90 days;
• Treatment with any other concomitant medication with primarily CNS activity, or treatment with any medication that the PI judges not acceptable for this study;
• history of seizures;
• Pregnancy or lactation.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• United States Department of Defense: collaborator
• Emory University: collaborator
• University of Southern California: collaborator
• VA Long Beach Healthcare System: collaborator
• National Intrepid Center of Excellence: collaborator

Study Sites (5)

VA Long Beach Healthcare System

Long Beach, California, United States

Location

University of Southern California

Los Angeles, California, United States

Location

Emory University

Atlanta, Georgia, United States

Location

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

Bethesda, Maryland, United States

Location

Weill Cornell Medical College

New York, New York, United States

Location

Related Publications (2)

• 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.

  PMID: 35896533 DERIVED

• 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.

  PMID: 31669451 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. JoAnn Difede
• Organization: Weill Cornell Medical College

jdifede@med.cornell.edu

212 746 3079

Study Officials

• JoAnn Difede, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Barbara Rothbaum, Ph.D., ABPP

  Emory University

  PRINCIPAL INVESTIGATOR

• Skip Rizzo, Ph. D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The two primary co-aims of this study 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.

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: May 12, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

US (5)