Comparing Virtual Reality Exposure Therapy to Prolonged Exposure

NCT01459705 | Completed Results DMC

• 2 other identifiers: 112226W81XWH-11-2-0007
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by comparing it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypothesis that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.

Conditions

Stress Disorders; Post-Traumatic Stress Disorder

Keywords

Combat Disorders; Exposure Therapy; Army Personnel

Outcome Measures

Primary Outcomes (5)

• Clinician-Administered PTSD Scale (CAPS)

  The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) PTSD criteria in terms of frequency and intensity. We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.

  Screening Visit (Day 1)

• Clinician-Administered PTSD Scale (CAPS)

  The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.

  2.5 weeks (or after treatment session 5)

• Clinician-Administered PTSD Scale (CAPS)

  The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.

  5 weeks (or after treatment session 10)

• Clinician-Administered PTSD Scale (CAPS)

  The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.

  12 week follow up

• Clinician-Administered PTSD Scale (CAPS)

  The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.

  26 Week follow up

Secondary Outcomes (82)

• PTSD Checklist- Civilian (PCL-C)

  Screening Visit (Day 1)

• Primary Care PTSD Screen (PC-PTSD)

  Screening Visit (Day 1)

• Beck Depression Inventory-II (BDI-II)

  Screening Visit(Day 1)

• Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)

  Screening Visit(Day 1)

• Perceived Stigma Measure (PSS)

  Screening Visit(Day 1)

Study Arms (3)

Prolonged Exposure Therapy (PE)

ACTIVE COMPARATOR

The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.

Behavioral: Prolonged Exposure Therapy (PE)

Virtual Reality Exposure Therapy (VRET)

EXPERIMENTAL

The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.

Behavioral: Virtual Reality Exposure Therapy (VRET)

Waitlist

PLACEBO COMPARATOR

The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.

Behavioral: Waitlist

Interventions

Prolonged Exposure Therapy (PE) BEHAVIORAL

Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

Also known as: PE

Prolonged Exposure Therapy (PE)

Virtual Reality Exposure Therapy (VRET) BEHAVIORAL

Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.

Also known as: VRE, VRET

Virtual Reality Exposure Therapy (VRET)

Waitlist BEHAVIORAL

This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation

Also known as: WL, Waitlist Control Group

Waitlist

Eligibility Criteria

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

You may qualify if:

• PTSD diagnosis as assessed by CAPS
• history of deployment in support of Operation Iraqi Freedom/ Operation Enduring Freedom(OIF/OEF)
• non sexually based deployment related trauma
• three or more months since index trauma
• stable on psychotropic medication for 30 days

You may not qualify if:

• index trauma in the last three months
• history of schizophrenia, other psychotic or bipolar disorder
• history of organic brain disorder
• suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months
• ongoing threatening situation
• current drug or alcohol dependence
• history of seizures
• prior history of PE for PTSD
• other current psychotherapy
• physical condition that interferes with proper use of Virtual Reality head mounted display
• history of loss of consciousness since entering active duty service greater than 15 minutes history of schizophrenia, other psychotic or bipolar disorder

Sponsors & Collaborators

• National Center for Telehealth and Technology: lead
• The Geneva Foundation: collaborator

Study Sites (1)

Womack Clinical Psychology Service

Fort Bragg, North Carolina, 28307, United States

Location

Related Publications (77)

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MeSH Terms

Conditions

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders

Interventions

Virtual Reality Exposure Therapy; Waiting Lists

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Gregory A. Gahm, PhD
• Organization: DCoE

gregory.a.gahm.civ@mail.mil

253-320-5772

Study Officials

• Gregory A Gahm, PhD

  DCoE- National Center for Telehealth and Technology

  PRINCIPAL INVESTIGATOR

• Greg Reger, PhD

  DCoE - National Center for Telehealth and Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 14, 2015
• Results First Posted: December 14, 2015

Record last verified: 2015-11

Locations

US (1)