ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Virtual Reality Exposure Therapy to Prolonged Exposure (VRPE Extension)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01459705
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
The Geneva Foundation
Information provided by (Responsible Party):
National Center for Telehealth and Technology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stress Disorders
Post-Traumatic Stress Disorder
Interventions Behavioral: Prolonged Exposure Therapy (PE)
Behavioral: Virtual Reality Exposure Therapy (VRET)
Behavioral: Waitlist
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist
Hide Arm/Group Description

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.

Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

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.

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

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

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

Period Title: Overall Study
Started 54 54 54
Completed 32 30 47
Not Completed 22 24 7
Arm/Group Title Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist Total
Hide Arm/Group Description

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.

Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

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.

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 54 54 54 162
Hide Baseline Analysis Population Description
All participants randomized to a treatment arm included in baseline data analysis
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 54 participants 162 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
54
 100.0%
54
 100.0%
54
 100.0%
162
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 54 participants 54 participants 162 participants
30.89  (7.09) 29.52  (6.47) 30.39  (6.45) 30.27  (6.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 54 participants 162 participants
Female
3
   5.6%
2
   3.7%
1
   1.9%
6
   3.7%
Male
51
  94.4%
52
  96.3%
53
  98.1%
156
  96.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants 54 participants 54 participants 162 participants
54 54 54 162
1.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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.
Time Frame Screening Visit (Day 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Baseline scores on the CAPS-W (last week reference)
Arm/Group Title Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist
Hide Arm/Group Description:

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.

Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

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.

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

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

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

Overall Number of Participants Analyzed 54 54 54
Mean (Standard Deviation)
Unit of Measure: units on scale
78.28  (16.35) 80.44  (16.23) 78.89  (16.87)
2.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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.
Time Frame 2.5 weeks (or after treatment session 5)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who provided data at mid treatment
Arm/Group Title Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist
Hide Arm/Group Description:

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.

Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

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.

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

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

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

Overall Number of Participants Analyzed 39 36 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
65.03  (29.19) 71.19  (23.27) 74.73  (21.78)
3.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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.
Time Frame 5 weeks (or after treatment session 10)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who provided outcome data at post treatment
Arm/Group Title Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist
Hide Arm/Group Description:

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.

Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

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.

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

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

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

Overall Number of Participants Analyzed 32 30 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
44.28  (33.73) 57.07  (32.32) 68.06  (24.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolonged Exposure Therapy (PE), Waitlist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -22.34
Parameter Dispersion
Type: Standard Deviation
Value: 4.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Virtual Reality Exposure Therapy (VRET), Waitlist
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -13.30
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.77
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 9.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.11
Estimation Comments [Not Specified]
4.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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.
Time Frame 12 week follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET)
Hide Arm/Group Description:

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.

Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

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.

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

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
36.63  (31.80) 55.88  (31.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 15.07
Parameter Dispersion
Type: Standard Deviation
Value: 6.03
Estimation Comments [Not Specified]
5.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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.
Time Frame 26 Week follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET)
Hide Arm/Group Description:

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.

Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

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.

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

Overall Number of Participants Analyzed 24 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
38.33  (28.49) 54.47  (28.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 13.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.70
Estimation Comments [Not Specified]
6.Secondary Outcome
Title PTSD Checklist- Civilian (PCL-C)
Hide Description The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame Screening Visit (Day 1)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Primary Care PTSD Screen (PC-PTSD)
Hide Description The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame Screening Visit (Day 1)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide Description This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame Screening Visit(Day 1)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Hide Description The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Time Frame Screening Visit(Day 1)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Perceived Stigma Measure (PSS)
Hide Description Stigma will be measured using a 5 question assessment scale.
Time Frame Screening Visit(Day 1)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Suicide Risk Assessment
Hide Description Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Screening Visit(Day 1)
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame Screening Visit(Day 1)
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Behavior and Sympton Identification Scale (BASIS-24)
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Screening Visit(Day 1)
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Screening Visit (Day 1)
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 1 (week 1)
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 1(week 1)
Outcome Measure Data Not Reported
17.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 1 (week 1)
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 1 (week 1)
Outcome Measure Data Not Reported
19.Secondary Outcome
Title PTSD Checklist (PCL-C)
Hide Description The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
20.Secondary Outcome
Title PTSD Checklist (PCL-C)
Hide Description The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame 5 weeks (or after treatment session 10)
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Primary Care PTSD Screen (PC-PTSD)
Hide Description The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
22.Secondary Outcome
Title PTSD Checklist (PCL-C)
Hide Description The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame 12 week follow up
Outcome Measure Data Not Reported
23.Secondary Outcome
Title PTSD Checklist (PCL-C)
Hide Description The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame 26 week follow up
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Primary Care PTSD Screen (PC-PTSD)
Hide Description The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame 5 weeks (or after treatment session 10)
Outcome Measure Data Not Reported
25.Secondary Outcome
Title Primary Care PTSD Screen (PC-PTSD)
Hide Description The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame 12 Week follow up
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Primary Care PTSD Screen (PC-PTSD)
Hide Description The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame 26 Week follow up
Outcome Measure Data Not Reported
27.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide Description This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
28.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide Description This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame 5 weeks (or after treatment session 10)
Outcome Measure Data Not Reported
29.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide Description This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame 12 Week follow up
Outcome Measure Data Not Reported
30.Secondary Outcome
Title Beck Depression Inventory-II (BDI-II)
Hide Description This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame 26 Week follow up
Outcome Measure Data Not Reported
31.Secondary Outcome
Title Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Hide Description The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
32.Secondary Outcome
Title Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Hide Description The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Time Frame 5 weeks (or after treatment session 10)
Outcome Measure Data Not Reported
33.Secondary Outcome
Title Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Hide Description The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Time Frame 12 Week follow up
Outcome Measure Data Not Reported
34.Secondary Outcome
Title Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Hide Description The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Time Frame 26 Week follow up
Outcome Measure Data Not Reported
35.Secondary Outcome
Title Perceived Stigma Measure (PSS)
Hide Description Stigma will be measured using a 5 question assessment scale.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
36.Secondary Outcome
Title Perceived Stigma Measure (PSS)
Hide Description Stigma will be measured using a 5 question assessment scale.
Time Frame 5 weeks (or after treatment session 10)
Outcome Measure Data Not Reported
37.Secondary Outcome
Title Perceived Stigma Measure (PSS)
Hide Description Stigma will be measured using a 5 question assessment scale.
Time Frame 12 week follow up
Outcome Measure Data Not Reported
38.Secondary Outcome
Title Perceived Stigma Measure (PSS)
Hide Description Stigma will be measured using a 5 question assessment scale.
Time Frame 26 week follow up
Outcome Measure Data Not Reported
39.Secondary Outcome
Title Suicide Risk Assessment
Hide Description Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
40.Secondary Outcome
Title Suicide Risk Assessment
Hide Description Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame 5 weeks (or after treatment session 10)
Outcome Measure Data Not Reported
41.Secondary Outcome
Title Suicide Risk Assessment
Hide Description Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame 12 Week follow up
Outcome Measure Data Not Reported
42.Secondary Outcome
Title Suicide Risk Assessment
Hide Description Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame 26 Week follow up
Outcome Measure Data Not Reported
43.Secondary Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
44.Secondary Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame 5 weeks (or after treatment session 10)
Outcome Measure Data Not Reported
45.Secondary Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame 12 week follow up
Outcome Measure Data Not Reported
46.Secondary Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame 26 week follow up
Outcome Measure Data Not Reported
47.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 2 (week 1)
Outcome Measure Data Not Reported
48.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 3 (week 2)
Outcome Measure Data Not Reported
49.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 4 (week 2)
Outcome Measure Data Not Reported
50.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 5 (week 2.5)
Outcome Measure Data Not Reported
51.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 6 (week 3)
Outcome Measure Data Not Reported
52.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 7 (week 4)
Outcome Measure Data Not Reported
53.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 8 (week 4)
Outcome Measure Data Not Reported
54.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 9 (week 5)
Outcome Measure Data Not Reported
55.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame Treatment session 10 (week 5)
Outcome Measure Data Not Reported
56.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame 5 weeks (or after treatment session 10)
Outcome Measure Data Not Reported
57.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
58.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame 12 week follow up
Outcome Measure Data Not Reported
59.Secondary Outcome
Title BASIS-24
Hide Description To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame 26 week follow up
Outcome Measure Data Not Reported
60.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 2 (week 1)
Outcome Measure Data Not Reported
61.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 3 (week 2)
Outcome Measure Data Not Reported
62.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 4 (week 2)
Outcome Measure Data Not Reported
63.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 5 (week 2.5)
Outcome Measure Data Not Reported
64.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 6 (week 3)
Outcome Measure Data Not Reported
65.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 7 (week 4)
Outcome Measure Data Not Reported
66.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 8 (week 4)
Outcome Measure Data Not Reported
67.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 9 (week 5)
Outcome Measure Data Not Reported
68.Secondary Outcome
Title Subjective Units of Distress (SUDs)
Hide Description Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Time Frame Treatment session 10 (week 5)
Outcome Measure Data Not Reported
69.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 2 (week 1)
Outcome Measure Data Not Reported
70.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 3 (week 2)
Outcome Measure Data Not Reported
71.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 4 (week 2)
Outcome Measure Data Not Reported
72.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 5 (week 2.5)
Outcome Measure Data Not Reported
73.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 6 (week 3)
Outcome Measure Data Not Reported
74.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 7 (week 4)
Outcome Measure Data Not Reported
75.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 8 (week 4)
Outcome Measure Data Not Reported
76.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 9 (week 5)
Outcome Measure Data Not Reported
77.Secondary Outcome
Title Side Effects Questionnaire
Hide Description The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Time Frame Treatment session 10 (week 5)
Outcome Measure Data Not Reported
78.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 2 (week 1)
Outcome Measure Data Not Reported
79.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 3 (week 2)
Outcome Measure Data Not Reported
80.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 4 (week 2)
Outcome Measure Data Not Reported
81.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 5 (week 2.5)
Outcome Measure Data Not Reported
82.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 6 (week 3)
Outcome Measure Data Not Reported
83.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 7 (week 4)
Outcome Measure Data Not Reported
84.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 8 (week 4)
Outcome Measure Data Not Reported
85.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 9 (week 5)
Outcome Measure Data Not Reported
86.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame Treatment session 10 (week 5)
Outcome Measure Data Not Reported
87.Secondary Outcome
Title Intent to Attend
Hide Description This is a measure to assess the intent to complete study procedures.
Time Frame 2.5 weeks (or after treatment session 5)
Outcome Measure Data Not Reported
Time Frame 6 months. From time of baseline visit to final follow up visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist
Hide Arm/Group Description

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.

Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

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.

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

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

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

All-Cause Mortality
Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/54 (0.00%)      3/54 (5.56%)      0/54 (0.00%)    
Psychiatric disorders       
Hospitalization - psychiatric * [1]  0/54 (0.00%)  0 3/54 (5.56%)  3 0/54 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
All three SAE's were for psychiatric hospitalization - not related to study
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prolonged Exposure Therapy (PE) Virtual Reality Exposure Therapy (VRET) Waitlist
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/54 (22.22%)      15/54 (27.78%)      0/54 (0.00%)    
Cardiac disorders       
chest pain *  1/54 (1.85%)  1 1/54 (1.85%)  2 0/54 (0.00%)  0
Gastrointestinal disorders       
Nausea *  5/54 (9.26%)  6 3/54 (5.56%)  4 0/54 (0.00%)  0
intermittent stomach ache and diarrhea *  0/54 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
General disorders       
Headache * [1]  7/54 (12.96%)  9 4/54 (7.41%)  8 0/54 (0.00%)  0
dizziness *  2/54 (3.70%)  2 1/54 (1.85%)  1 0/54 (0.00%)  0
flu like symptoms *  0/54 (0.00%)  0 1/54 (1.85%)  2 0/54 (0.00%)  0
cold symptoms *  0/54 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
syncopal episode *  1/54 (1.85%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
alcohol consumption * [2]  2/54 (3.70%)  2 0/54 (0.00%)  0 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Dislocated Shoulder * [3]  0/54 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
exacerbation of neck and back pain *  0/54 (0.00%)  0 1/54 (1.85%)  2 0/54 (0.00%)  0
Psychiatric disorders       
increase in flashbacks *  1/54 (1.85%)  3 0/54 (0.00%)  0 0/54 (0.00%)  0
homicidal ideation *  0/54 (0.00%)  0 2/54 (3.70%)  2 0/54 (0.00%)  0
increased intrusive memories *  0/54 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
increased irritability *  0/54 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
increased anxiety around weapons *  0/54 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
self percieved persecution * [4]  0/54 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Shortness of Breath *  1/54 (1.85%)  1 0/54 (0.00%)  0 0/54 (0.00%)  0
Skin and subcutaneous tissue disorders       
Eczema *  0/54 (0.00%)  0 1/54 (1.85%)  2 0/54 (0.00%)  0
rash from ECG lead *  0/54 (0.00%)  0 1/54 (1.85%)  1 0/54 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Headaches
[2]
Alcohol consumption after session
[3]
Shoulder dislocation during racket ball which was in in vivo homework exercise
[4]
starving self, vague suicidal ideation and homicidal ideation
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gregory A. Gahm, PhD
Organization: DCoE
Phone: 253-320-5772
Publications of Results:
Other Publications:
Bryant RA. Cognitive behavior therapy of violence-related posttraumatic stress disorder. Aggression and Violent Behavior. 2000;5:79-97.
Foa EB,Steketee GS, Rothbaum BO. Behavioral/cognitive conceptualizations of post-traumatic stress disorder. Behavior Therapy. 1989;20:155-176.
Foa EB, Hearst-Ikeda D. Emotional Dissociation in Response to Trauma: An Information-Processing Approach. In: Michelson LK, Ray WJ, eds. Handbook of Dissociation: Theoretical and Clinical Perspectives. New York: Plenum Press; 1996:207-222.
Lating JM, Everly GS, Jr. Psychophysiological assessment of PTSD. In: Everly, GS, Jr., Lating LM, eds. Psychotraumatology: Key papers and core concepts in post-traumatic stress. New York: Plenum Press; 1995:129-145.
Boudewyns P, Hyer L. Physiological response to combat memories and preliminary treatment outcome in Vietnam veteran PTSD patients treated with direct therapeutic exposure. Behavior Therapy. 1990;21 (1):63-87.
Britt TW. The stigma of psychological problems in a work environment: Evidence from the screening of Service Members returning from Bosnia. J of Applied Psych. 2000;30(8):1599-1618
Foa EB, Riggs DS, Massie ED, Yarczower M. The impact of fear activation and anger on the efficacy of exposure treatment for PTSD. Behavior Therapy. 1995;26:487-499.
Rizzo AA, Buckwalter JG, van der Zaag C. Virtual Environment Applications for Neuropsychological Assessment and Rehabilitation. In: Stanney K, ed. Handbook of Virtual Environments. New York: L.A. Earlbaum; 2002:1027-1064.
Smith SG, Rothbaum BO, Hodges L. Treatment of fear of flying using virtual reality exposure therapy: A single case study. The Behavior Therapist. 1999;22(8):154-158,160.
Anderson P, Rothbaum BO, Hodges LF. Virtual reality exposure in the treatment of social anxiety: Two case reports. Cognitive and Behavioral Practice. 2003;10:240-247.
Glantz K, Rizzo AA, Graap K. Virtual reality for psychotherapy: Current reality and future possibilities. Psychotherapy: Theory, Research, Practice, Training. 2003;40(1/2):55-67.
Rizzo AA, Schultheis MT, Kerns K, Mateer C. Analysis of assets for virtual applications in neuropsychology. Neuropsychological Rehabilitation. 2004;14(1/2):207-239.
Rizzo AA, Rothbaum BO, Graap K. Virtual Reality Applications for Combat-Related Posttraumatic Stress Disorder. In: Figley CR, Nash WP, eds. For Those Who Bore the Battle: Combat Stress Injury Theory, Research, and Management. New York: Taylor and Francis Books; 2006.
Rothbaum BO, Ruef AM, Litz BT, Han H, Hodges L. Virtual reality exposure therapy of combat-related PTSD: A case study using psychophysiological indicators of outcome. Journal of Cognitive Psychotherapy. 2003;17(2):163-177.
Cohen J. Statistical Power Analysis for the Behavioral Sciences. Hillsdale: Lawrence Earlbaum Associates; 1988.
Cohen J, Cohen P. Applied Multiple Regression/Correlation Analysis for the Behavioral Sciences. Hillsdale: Lawrence Earlbaum; 1983.
Foa EB, Hembree E, Rothbaum BO. Prolonged Exposure Therapy for PTSD: Emotional Processing of Traumatic Experiences. New York: Oxford University Press; 2007.
Nishith P, Resick PA. Adherence and competence rating scales for prolonged exposure treatment: Unpublished Rating Scale, University of Missouri-St. Louis; 1994.
Ajzen I. From intentions to actions: A theory of planned behavior. In: Kuhl J, Beckman, J, eds. Action-Control: From Cognition to Behavior. Heidelberg: Springer; 1985:11-39.
Komiya N, Good GE, Sherrod NB. Emotional openness as a predictor of college students' attitudes toward seeking psychological help. J Counsel Psychol. 2000;47(1):138-143.
Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG. Simulator Sickness Questionnaire: An enhanced method for quantifying simulator sickness. International Journal of Aviation Psychology. 1993;3(3):203-220.
Responsible Party: National Center for Telehealth and Technology
ClinicalTrials.gov Identifier: NCT01459705     History of Changes
Other Study ID Numbers: 112226
W81XWH-11-2-0007 ( Other Grant/Funding Number: USMRMC )
First Submitted: October 24, 2011
First Posted: October 26, 2011
Results First Submitted: October 9, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015