Trial Outcomes & Findings for Comparing Virtual Reality Exposure Therapy to Prolonged Exposure (NCT NCT01459705)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

162 participants

Primary outcome timeframe

Screening Visit (Day 1)

Results posted on

2015-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Prolonged Exposure Therapy (PE) 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.	Virtual Reality Exposure Therapy (VRET) 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.	Waitlist 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 Study STARTED	54	54	54
Overall Study COMPLETED	32	30	47
Overall Study NOT COMPLETED	22	24	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Virtual Reality Exposure Therapy to Prolonged Exposure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prolonged Exposure Therapy (PE) n=54 Participants 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.	Virtual Reality Exposure Therapy (VRET) n=54 Participants 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.	Waitlist n=54 Participants 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 n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=93 Participants	54 Participants n=4 Participants	54 Participants n=27 Participants	162 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	30.89 years STANDARD_DEVIATION 7.09 • n=93 Participants	29.52 years STANDARD_DEVIATION 6.47 • n=4 Participants	30.39 years STANDARD_DEVIATION 6.45 • n=27 Participants	30.27 years STANDARD_DEVIATION 6.66 • n=483 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	6 Participants n=483 Participants
Sex: Female, Male Male	51 Participants n=93 Participants	52 Participants n=4 Participants	53 Participants n=27 Participants	156 Participants n=483 Participants
Region of Enrollment United States	54 participants n=93 Participants	54 participants n=4 Participants	54 participants n=27 Participants	162 participants n=483 Participants

PRIMARY outcome

Timeframe: Screening Visit (Day 1)

Population: Baseline scores on the CAPS-W (last week reference)

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.

Outcome measures

Outcome measures
Measure	Prolonged Exposure Therapy (PE) n=54 Participants 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.	Virtual Reality Exposure Therapy (VRET) n=54 Participants 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.	Waitlist n=54 Participants 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
Clinician-Administered PTSD Scale (CAPS)	78.28 units on scale Standard Deviation 16.35	80.44 units on scale Standard Deviation 16.23	78.89 units on scale Standard Deviation 16.87

PRIMARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

Population: Participants who provided data at mid treatment

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.

Outcome measures

Outcome measures
Measure	Prolonged Exposure Therapy (PE) n=39 Participants 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.	Virtual Reality Exposure Therapy (VRET) n=36 Participants 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.	Waitlist n=52 Participants 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
Clinician-Administered PTSD Scale (CAPS)	65.03 units on a scale Standard Deviation 29.19	71.19 units on a scale Standard Deviation 23.27	74.73 units on a scale Standard Deviation 21.78

PRIMARY outcome

Timeframe: 5 weeks (or after treatment session 10)

Population: Participants who provided outcome data at post treatment

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.

Outcome measures

Outcome measures
Measure	Prolonged Exposure Therapy (PE) n=32 Participants 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.	Virtual Reality Exposure Therapy (VRET) n=30 Participants 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.	Waitlist n=47 Participants 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
Clinician-Administered PTSD Scale (CAPS)	44.28 units on a scale Standard Deviation 33.73	57.07 units on a scale Standard Deviation 32.32	68.06 units on a scale Standard Deviation 24.27

PRIMARY outcome

Timeframe: 12 week follow up

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.

Outcome measures

Outcome measures
Measure	Prolonged Exposure Therapy (PE) n=27 Participants 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.	Virtual Reality Exposure Therapy (VRET) n=26 Participants 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.	Waitlist 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
Clinician-Administered PTSD Scale (CAPS)	36.63 units on a scale Standard Deviation 31.80	55.88 units on a scale Standard Deviation 31.10	—

PRIMARY outcome

Timeframe: 26 Week follow up

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.

Outcome measures

Outcome measures
Measure	Prolonged Exposure Therapy (PE) n=24 Participants 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.	Virtual Reality Exposure Therapy (VRET) n=17 Participants 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.	Waitlist 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
Clinician-Administered PTSD Scale (CAPS)	38.33 units on a scale Standard Deviation 28.49	54.47 units on a scale Standard Deviation 28.62	—

SECONDARY outcome

Timeframe: Screening Visit (Day 1)

The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit (Day 1)

The PC-PTSD is a four-item measure designed to screen for PTSD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit(Day 1)

This self report measure of depression contains 21 items that are rated on a 4 point scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit(Day 1)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit(Day 1)

Stigma will be measured using a 5 question assessment scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit(Day 1)

Due to the nature of the questions, this is deemed to be of safety nature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit(Day 1)

The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit(Day 1)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit (Day 1)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 1 (week 1)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 1(week 1)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 1 (week 1)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 1 (week 1)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks (or after treatment session 10)

The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

The PC-PTSD is a four-item measure designed to screen for PTSD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 week follow up

The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 week follow up

The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks (or after treatment session 10)

The PC-PTSD is a four-item measure designed to screen for PTSD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Week follow up

The PC-PTSD is a four-item measure designed to screen for PTSD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 Week follow up

The PC-PTSD is a four-item measure designed to screen for PTSD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

This self report measure of depression contains 21 items that are rated on a 4 point scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks (or after treatment session 10)

This self report measure of depression contains 21 items that are rated on a 4 point scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Week follow up

This self report measure of depression contains 21 items that are rated on a 4 point scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 Week follow up

This self report measure of depression contains 21 items that are rated on a 4 point scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks (or after treatment session 10)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Week follow up

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 Week follow up

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

Stigma will be measured using a 5 question assessment scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks (or after treatment session 10)

Stigma will be measured using a 5 question assessment scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 week follow up

Stigma will be measured using a 5 question assessment scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 week follow up

Stigma will be measured using a 5 question assessment scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

Due to the nature of the questions, this is deemed to be of safety nature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks (or after treatment session 10)

Due to the nature of the questions, this is deemed to be of safety nature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 Week follow up

Due to the nature of the questions, this is deemed to be of safety nature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 Week follow up

Due to the nature of the questions, this is deemed to be of safety nature.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks (or after treatment session 10)

The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 week follow up

The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 week follow up

The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 2 (week 1)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 3 (week 2)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 4 (week 2)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 5 (week 2.5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 6 (week 3)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 7 (week 4)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 8 (week 4)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 9 (week 5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 10 (week 5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks (or after treatment session 10)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 week follow up

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 week follow up

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 2 (week 1)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 3 (week 2)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 4 (week 2)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 5 (week 2.5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 6 (week 3)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 7 (week 4)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 8 (week 4)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 9 (week 5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 10 (week 5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 2 (week 1)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 3 (week 2)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 4 (week 2)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 5 (week 2.5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 6 (week 3)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 7 (week 4)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 8 (week 4)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 9 (week 5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 10 (week 5)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 2 (week 1)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 3 (week 2)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 4 (week 2)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 5 (week 2.5)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 6 (week 3)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 7 (week 4)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 8 (week 4)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 9 (week 5)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Treatment session 10 (week 5)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2.5 weeks (or after treatment session 5)

This is a measure to assess the intent to complete study procedures.

Outcome measures

Outcome data not reported

Adverse Events

Prolonged Exposure Therapy (PE)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Virtual Reality Exposure Therapy (VRET)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Waitlist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prolonged Exposure Therapy (PE) n=54 participants at risk 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.	Virtual Reality Exposure Therapy (VRET) n=54 participants at risk 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.	Waitlist n=54 participants at risk 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
Psychiatric disorders Hospitalization - psychiatric	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	5.6% 3/54 • Number of events 3 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit

Other adverse events

Additional Information

Gregory A. Gahm, PhD

DCoE

Phone: 253-320-5772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Prolonged Exposure Therapy (PE) n=54 participants at risk 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.	Virtual Reality Exposure Therapy (VRET) n=54 participants at risk 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.	Waitlist n=54 participants at risk 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
Psychiatric disorders increase in flashbacks	1.9% 1/54 • Number of events 3 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
General disorders Headache	13.0% 7/54 • Number of events 9 • 6 months. From time of baseline visit to final follow up visit	7.4% 4/54 • Number of events 8 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Musculoskeletal and connective tissue disorders Dislocated Shoulder	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Musculoskeletal and connective tissue disorders exacerbation of neck and back pain	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 2 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Cardiac disorders chest pain	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 2 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Gastrointestinal disorders Nausea	9.3% 5/54 • Number of events 6 • 6 months. From time of baseline visit to final follow up visit	5.6% 3/54 • Number of events 4 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Skin and subcutaneous tissue disorders Eczema	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 2 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
General disorders dizziness	3.7% 2/54 • Number of events 2 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Psychiatric disorders homicidal ideation	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	3.7% 2/54 • Number of events 2 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Gastrointestinal disorders intermittent stomach ache and diarrhea	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Psychiatric disorders increased intrusive memories	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Psychiatric disorders increased irritability	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Respiratory, thoracic and mediastinal disorders Shortness of Breath	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Psychiatric disorders increased anxiety around weapons	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
General disorders flu like symptoms	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 2 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
General disorders cold symptoms	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
General disorders syncopal episode	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Skin and subcutaneous tissue disorders rash from ECG lead	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
General disorders alcohol consumption	3.7% 2/54 • Number of events 2 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit
Psychiatric disorders self percieved persecution	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit	1.9% 1/54 • Number of events 1 • 6 months. From time of baseline visit to final follow up visit	0.00% 0/54 • 6 months. From time of baseline visit to final follow up visit