Trial Outcomes & Findings for Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD (NCT NCT01965366)
NCT ID: NCT01965366
Last Updated: 2018-07-12
Results Overview
The Clinician Administered PTSD Scale (CAPS) provides a diagnostic measure of PTSD and a continuous measure of the severity, frequency, and intensity of the three symptom clusters (intrusion, avoidance, and arousal) and overall PTSD. The assessor combines information about frequency and intensity of an item into a single severity rating. Severity Rating: 0. Absent; 1. Mild / subthreshold;2. Moderate / threshold; 3. Severe / markedly elevated; 4.Extreme / incapacitating. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Scores may range from 0-80, with a higher score indicating more reported symptoms of PTSD.
COMPLETED
PHASE4
27 participants
Baseline and immediate post treatment (up to 12 weeks from baseline)
2018-07-12
Participant Flow
Participant milestones
| Measure |
Dexamethasone + VRE
0.5 mg DEX + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions.
|
Placebo + VRE
Placebo + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD
Baseline characteristics by cohort
| Measure |
Dexamethasone + VRE
n=13 Participants
0.5 mg DEX + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions.
|
Placebo + VRE
n=14 Participants
Placebo + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
black
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and immediate post treatment (up to 12 weeks from baseline)The Clinician Administered PTSD Scale (CAPS) provides a diagnostic measure of PTSD and a continuous measure of the severity, frequency, and intensity of the three symptom clusters (intrusion, avoidance, and arousal) and overall PTSD. The assessor combines information about frequency and intensity of an item into a single severity rating. Severity Rating: 0. Absent; 1. Mild / subthreshold;2. Moderate / threshold; 3. Severe / markedly elevated; 4.Extreme / incapacitating. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Scores may range from 0-80, with a higher score indicating more reported symptoms of PTSD.
Outcome measures
| Measure |
Dexamethasone + VRE
n=3 Participants
0.5 mg DEX + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions.
|
Placebo + VRE
n=9 Participants
Placebo + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
|
|---|---|---|
|
Change in The Clinician Administered PTSD Scale (CAPS)Scores
|
-11 units on a scale
Standard Deviation 10.44
|
-15.22 units on a scale
Standard Deviation 12.40
|
SECONDARY outcome
Timeframe: Baseline and immediate post treatment (up to 12 weeks from baseline)The PTSD Symptom Scale (PSS) is a 17-item interview used to aid in the detection and diagnosis of PTSD. The structure and content of the PSS mirror the DSM-IV criteria for PTSD. For each item, the interviewer assigns a rating to reflect a combination of frequency and severity (from O = "not at all" to 3 = "5 or more times per week/very much"). Scores range from 0-51, with higher scores indicating more reported symptoms of PTSD. A score of 13 or higher indicates the likelihood of PTSD.
Outcome measures
| Measure |
Dexamethasone + VRE
n=3 Participants
0.5 mg DEX + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
0.5 mg DEX: A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions.
|
Placebo + VRE
n=9 Participants
Placebo + virtual reality exposure therapy
Virtual reality exposure therapy: Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
|
|---|---|---|
|
Change in The PTSD Symptom Scale Scores
|
-9 units on a scale
Standard Deviation 16.97
|
-16.65 units on a scale
Standard Deviation 12.69
|
Adverse Events
Dexamethasone + VRE
Placebo + VRE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place