Trial Outcomes & Findings for Enhancing Exposure Therapy for Post Traumatic Stress Disorder (PTSD): Virtual Reality and Imaginal Exposure With a Cognitive Enhancer (NCT NCT01352637)
NCT ID: NCT01352637
Last Updated: 2019-07-02
Results Overview
Clinician Administered PTSD Scale (CAPS) for the DSM-IV \[34\]. The CAPS-IV is a structured clinical interview designed to assess the 17 DSM-IV PTSD symptoms. CAPS-IV provides categorical ratings of diagnostic status as well as a quantitative index of symptom severity. The CAPS total severity score is based on response to the 17 items that assess the frequency and intensity of current PTSD symptoms. Symptom severity is assessed separately for past month and past week time frames. CAPS-IV range is 0-136, higher scores mean a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
after weekly treatment session 9 (at posttreatment assessment)
Results posted on
2019-07-02
Participant Flow
Total sample size is n=192. Randomization allocation ratio was 1:1:1:1 to VRE vs. PE and DCS vs. placebo. Study had 2 co-primary aims to examine: 1. the effects of DCS (n=95) vs placebo (n=97) augmentation of exposure therapy 2. the relative efficacy of VRE (n=97) and PE (n=95) on PTSD symptoms.
Participant milestones
| Measure |
Virtual Reality Exposure (VRE)
Virtual Reality Exposure (VRE): PTSD treatment
|
Prolonged Imaginal Exposure (PE)
Drug: Placebo (sugar pill) + Virtual Reality Exposure (VR) PTSD treatment
Prolonged Imaginal Exposure (PE): PTSD treatment
|
Drug: D-Cycloserine (DCS)
D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
|
Drug: Placebo
Drug: Placebo (sugar pill) (taken once a week on the day of the therapy session)
|
|---|---|---|---|---|
|
Exposure Therapy
STARTED
|
97
|
95
|
0
|
0
|
|
Exposure Therapy
COMPLETED
|
70
|
62
|
0
|
0
|
|
Exposure Therapy
NOT COMPLETED
|
27
|
33
|
0
|
0
|
|
Drug
STARTED
|
0
|
0
|
95
|
97
|
|
Drug
COMPLETED
|
0
|
0
|
70
|
62
|
|
Drug
NOT COMPLETED
|
0
|
0
|
25
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Exposure Therapy for Post Traumatic Stress Disorder (PTSD): Virtual Reality and Imaginal Exposure With a Cognitive Enhancer
Baseline characteristics by cohort
| Measure |
Virtual Reality Exposure (VRE)+Drug: DCycloserine (DCS)
n=47 Participants
Virtual Reality Exposure (VRE): PTSD treatment + D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
|
Prolonged Imaginal Exposure (PE)+Drug: DCycloserine (DCS)
n=48 Participants
Prolonged Imaginal Exposure (PE): PTSD treatment + D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
|
Virtual Reality Exposure (VRE)+Drug: Placebo
n=50 Participants
Virtual Reality Exposure (VRE): PTSD treatment + Placebo (sugar pill) (taken once a week on the day of the therapy session)
|
Prolonged Imaginal Exposure (PE)+Drug: Placebo
n=47 Participants
Prolonged Imaginal Exposure (PE): PTSD treatment + Placebo (sugar pill) (taken once a week on the day of the therapy session)
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.74 years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
36.17 years
STANDARD_DEVIATION 8.53 • n=7 Participants
|
34.80 years
STANDARD_DEVIATION 6.99 • n=5 Participants
|
33.70 years
STANDARD_DEVIATION 7.95 • n=4 Participants
|
34.62 years
STANDARD_DEVIATION 7.80 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
172 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
CAPS-IV, past week
|
71.72 units on a scale
STANDARD_DEVIATION 19.98 • n=5 Participants
|
75.08 units on a scale
STANDARD_DEVIATION 18.69 • n=7 Participants
|
74.46 units on a scale
STANDARD_DEVIATION 19.11 • n=5 Participants
|
70.74 units on a scale
STANDARD_DEVIATION 200.37 • n=4 Participants
|
73.04 units on a scale
STANDARD_DEVIATION 19.47 • n=21 Participants
|
PRIMARY outcome
Timeframe: after weekly treatment session 9 (at posttreatment assessment)Population: Total sample size is n=192. Randomization allocation ratio was 1:1:1:1 to VRE vs. PE and DCS vs. placebo. Study had 2 co-primary aims to examine: 1. the effects of DCS (n=95) vs placebo (n=97) augmentation of exposure therapy 2. the relative efficacy of VRE (n=97) and PE (n=95) on PTSD symptoms.
Clinician Administered PTSD Scale (CAPS) for the DSM-IV \[34\]. The CAPS-IV is a structured clinical interview designed to assess the 17 DSM-IV PTSD symptoms. CAPS-IV provides categorical ratings of diagnostic status as well as a quantitative index of symptom severity. The CAPS total severity score is based on response to the 17 items that assess the frequency and intensity of current PTSD symptoms. Symptom severity is assessed separately for past month and past week time frames. CAPS-IV range is 0-136, higher scores mean a worse outcome.
Outcome measures
| Measure |
Virtual Reality Exposure (VRE)
n=97 Participants
Virtual Reality Exposure (VRE): PTSD treatment
|
Prolonged Imaginal Exposure (PE)
n=95 Participants
Prolonged Imaginal Exposure (PE): PTSD treatment
|
Drug: D-Cycloserine (DCS)
n=95 Participants
D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
|
Drug: Placebo
n=97 Participants
Drug: Placebo (sugar pill) (taken once a week on the day of the therapy session)
|
|---|---|---|---|---|
|
CAPS-IV at the End of Treatment
|
52.42 units on a scale
Standard Deviation 26.55
|
50.61 units on a scale
Standard Deviation 25.22
|
54.20 units on a scale
Standard Deviation 26.72
|
48.59 units on a scale
Standard Deviation 24.71
|
Adverse Events
Virtual Reality Exposure (VRE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prolonged Imaginal Exposure (PE)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Drug: D-Cycloserine (DCS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Drug: Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Virtual Reality Exposure (VRE)
n=97 participants at risk
Virtual Reality Exposure (VRE): PTSD treatment
|
Prolonged Imaginal Exposure (PE)
n=95 participants at risk
Prolonged Imaginal Exposure (PE): PTSD treatment
|
Drug: D-Cycloserine (DCS)
n=95 participants at risk
D-Cycloserine (DCS) (taken once a week on the day of the therapy session)
|
Drug: Placebo
n=97 participants at risk
Drug: Placebo (sugar pill) (taken once a week on the day of the therapy session)
|
|---|---|---|---|---|
|
Infections and infestations
Hospitalization
|
0.00%
0/97 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
1.1%
1/95 • Number of events 1 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
0.00%
0/95 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
0.00%
0/97 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/97 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
1.1%
1/95 • Number of events 1 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
0.00%
0/95 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
0.00%
0/97 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
|
Injury, poisoning and procedural complications
Hopitalization
|
0.00%
0/97 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
1.1%
1/95 • Number of events 1 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
0.00%
0/95 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
1.0%
1/97 • Number of events 1 • During treatment (9 weekly therapy sessions).
18-item Side Effect Screening Checklist was administered at each therapy session to identify possible medication-related side effects and specific adverse symptoms.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place