Trial Outcomes & Findings for Prevention of Post Sexual Assault Stress (NCT NCT01430624)
NCT ID: NCT01430624
Last Updated: 2016-04-13
Results Overview
quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
245 participants
Primary outcome timeframe
14 days preceding 6 week, 3 month and 6 month follow-up
Results posted on
2016-04-13
Participant Flow
Participant milestones
| Measure |
PPRS Video
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
Treatment as usual
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
81
|
|
Overall Study
Eligible Baseline Completes
|
77
|
77
|
79
|
|
Overall Study
COMPLETED
|
54
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
28
|
34
|
29
|
Reasons for withdrawal
| Measure |
PPRS Video
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
Treatment as usual
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
29
|
27
|
|
Overall Study
technical or eligibility
|
5
|
5
|
2
|
Baseline Characteristics
Prevention of Post Sexual Assault Stress
Baseline characteristics by cohort
| Measure |
PPRS (Completing Baseline)
n=77 Participants
Prevention of Post-Sexual Assault Stress
|
PIRI (Completing Baseline)
n=77 Participants
Pleasant Imagery and Relaxation Instruction
|
Standard Care (Completing Baseline)
n=79 Participants
Standard Care Condition completing baseline
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
223 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
26.79 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
27.99 years
STANDARD_DEVIATION 10.77 • n=7 Participants
|
27.52 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
27.43 years
STANDARD_DEVIATION 9.70 • n=4 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
77 participants
n=7 Participants
|
79 participants
n=5 Participants
|
233 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only includes participants with complete scale data at 6 months
total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months
Outcome measures
| Measure |
PPRS Video
n=34 Participants
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
n=39 Participants
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
n=39 Participants
Treatment as usual
|
|---|---|---|---|
|
Drug Abuse Screening Test (DAST-10)
|
1.97 units on a scale
Standard Deviation 2.65
|
2.03 units on a scale
Standard Deviation 2.85
|
1.18 units on a scale
Standard Deviation 1.62
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Includes only participants with full scale score information at 6 months
Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months
Outcome measures
| Measure |
PPRS Video
n=33 Participants
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
n=40 Participants
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
n=41 Participants
Treatment as usual
|
|---|---|---|---|
|
Alcohol Use Disorders Identification Test (AUDIT)
|
7.21 units on a scale
Standard Deviation 8.73
|
7.53 units on a scale
Standard Deviation 9.69
|
8.15 units on a scale
Standard Deviation 7.42
|
PRIMARY outcome
Timeframe: 14 days preceding 6 week, 3 month and 6 month follow-upPopulation: 1 participant missing 6 week cigarette smoking information
quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
Outcome measures
| Measure |
PPRS Video
n=53 Participants
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
n=48 Participants
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
n=52 Participants
Treatment as usual
|
|---|---|---|---|
|
Cigarettes (Estimated Number)
6 Week (n = 53, 48, 52)
|
49.94 cigarettes
Standard Error 80.19
|
87.29 cigarettes
Standard Error 141.20
|
118.04 cigarettes
Standard Error 114.94
|
|
Cigarettes (Estimated Number)
3 Month (n = 48, 44, 43)
|
54.63 cigarettes
Standard Error 121.22
|
67.73 cigarettes
Standard Error 129.01
|
84.47 cigarettes
Standard Error 100.54
|
|
Cigarettes (Estimated Number)
6 Month (n = 38, 41, 42)
|
42.68 cigarettes
Standard Error 76.78
|
71.71 cigarettes
Standard Error 126.15
|
84.64 cigarettes
Standard Error 92.67
|
PRIMARY outcome
Timeframe: 14 days prior to 6 week, 3 month, 6 month follow-upPopulation: 1 participant with missing data at 6 week follow-up
estimated number of drinks during the 14 days prior to each follow-up assessment
Outcome measures
| Measure |
PPRS Video
n=54 Participants
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
n=48 Participants
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
n=51 Participants
Treatment as usual
|
|---|---|---|---|
|
Amount of Alcohol Use
6 Week (n = 54, 48, 51)
|
15.33 Drinks
Standard Deviation 21.20
|
13.92 Drinks
Standard Deviation 28.17
|
19.90 Drinks
Standard Deviation 43.73
|
|
Amount of Alcohol Use
3 Month (n = 48, 44, 43)
|
8.29 Drinks
Standard Deviation 12.81
|
14.32 Drinks
Standard Deviation 22.47
|
11.49 Drinks
Standard Deviation 15.66
|
|
Amount of Alcohol Use
6 Month (n = 38, 41, 42)
|
10.16 Drinks
Standard Deviation 21.42
|
10.49 Drinks
Standard Deviation 21.58
|
14.60 Drinks
Standard Deviation 22.62
|
PRIMARY outcome
Timeframe: 14 days prior to 6 week, 3 month, 6 month follow-upNumber of days of use within the 14 days prior to follow-up assessment
Outcome measures
| Measure |
PPRS Video
n=54 Participants
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
n=48 Participants
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
n=52 Participants
Treatment as usual
|
|---|---|---|---|
|
Marijuana Use Frequency
6 Week (n = 54, 48, 52)
|
1.98 days of use
Standard Deviation 3.85
|
2.48 days of use
Standard Deviation 4.52
|
2.12 days of use
Standard Deviation 4.42
|
|
Marijuana Use Frequency
3 Month (n = 48, 44, 43)
|
2.75 days of use
Standard Deviation 4.94
|
1.39 days of use
Standard Deviation 2.81
|
2.12 days of use
Standard Deviation 4.28
|
|
Marijuana Use Frequency
6 Month (n = 38, 41, 42)
|
1.03 days of use
Standard Deviation 2.70
|
1.73 days of use
Standard Deviation 3.98
|
2.90 days of use
Standard Deviation 5.40
|
SECONDARY outcome
Timeframe: 14 days prior to 6 week, 3 month, 6 month follow-upAny reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up
Outcome measures
| Measure |
PPRS Video
n=54 Participants
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
n=48 Participants
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
n=52 Participants
Treatment as usual
|
|---|---|---|---|
|
Any Other Illicit Drug Use
6 Week (n = 54, 48, 52)
|
6 participants
|
0 participants
|
2 participants
|
|
Any Other Illicit Drug Use
3 Month (n = 48, 42, 43)
|
4 participants
|
3 participants
|
2 participants
|
|
Any Other Illicit Drug Use
6 Month (n = 38, 41, 42)
|
4 participants
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 14 days prior to 6 week, 3 month, 6 month follow-upPopulation: 2 participants had missing data at 6 month follow-up
Number of days of use within the 14 days prior to follow-up assessment
Outcome measures
| Measure |
PPRS Video
n=54 Participants
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
n=48 Participants
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
n=52 Participants
Treatment as usual
|
|---|---|---|---|
|
Non-medical Use of Prescription Drugs Frequency
6 Week (n = 54, 48, 52)
|
1.56 days of use
Standard Deviation 3.96
|
.08 days of use
Standard Deviation .35
|
.54 days of use
Standard Deviation 1.60
|
|
Non-medical Use of Prescription Drugs Frequency
3 Month (n = 48, 44, 43)
|
.81 days of use
Standard Deviation 2.57
|
.75 days of use
Standard Deviation 2.63
|
.16 days of use
Standard Deviation .62
|
|
Non-medical Use of Prescription Drugs Frequency
6 Month (n = 38, 40, 41)
|
.61 days of use
Standard Deviation 2.39
|
.40 days of use
Standard Deviation 1.19
|
.10 days of use
Standard Deviation .63
|
SECONDARY outcome
Timeframe: 2 weeks prior to 6 week, 3 month, 6 month followupPopulation: Only includes those with complete scale score information
Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.
Outcome measures
| Measure |
PPRS Video
n=52 Participants
Prevention of post sexual assault stress
PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
|
PIRI Video
n=43 Participants
Pleasant imagery and relaxation instruction
PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
|
Standard Care
n=49 Participants
Treatment as usual
|
|---|---|---|---|
|
PTSD Symptom Scale Self-Report (PSS-SR)
6 Week (n = 52, 43, 49)
|
26.98 units on a scale
Standard Deviation 10.42
|
29.07 units on a scale
Standard Deviation 11.48
|
24.49 units on a scale
Standard Deviation 11.63
|
|
PTSD Symptom Scale Self-Report (PSS-SR)
3 Month (n = 45, 42, 43)
|
23.98 units on a scale
Standard Deviation 11.09
|
23.33 units on a scale
Standard Deviation 13.03
|
21.70 units on a scale
Standard Deviation 12.56
|
|
PTSD Symptom Scale Self-Report (PSS-SR)
6 Month (n = 35, 37, 41)
|
17.66 units on a scale
Standard Deviation 11.83
|
21.65 units on a scale
Standard Deviation 12.80
|
19.83 units on a scale
Standard Deviation 12.47
|
Adverse Events
PPRS
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
PIRI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PPRS
n=82 participants at risk
Prevention of Post-Sexual Assault Stress
|
PIRI
n=82 participants at risk
Pleasant Imagery and Relaxation Instruction
|
Standard Care Condition
n=81 participants at risk
Standard Care Condition
|
|---|---|---|---|
|
General disorders
death
|
1.2%
1/82 • Number of events 1 • 6 months
Cause of death and cause of hospitalization unknown
|
0.00%
0/82 • 6 months
Cause of death and cause of hospitalization unknown
|
0.00%
0/81 • 6 months
Cause of death and cause of hospitalization unknown
|
|
Psychiatric disorders
Hospitalization
|
1.2%
1/82 • Number of events 1 • 6 months
Cause of death and cause of hospitalization unknown
|
0.00%
0/82 • 6 months
Cause of death and cause of hospitalization unknown
|
0.00%
0/81 • 6 months
Cause of death and cause of hospitalization unknown
|
Other adverse events
Adverse event data not reported
Additional Information
Heidi Resnick, Ph.D.
Medical University of South Carolina
Phone: 843-792-2945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place