Prevention of Post Sexual Assault Stress

Prevention of Postrape Drug Abuse: Replication Study

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01430624

Enrollment

245

Registered

2011-09-08

Start date

2009-05-31

Completion date

2013-12-31

Last updated

2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Abuse, Drug Use, Posttraumatic Stress Disorder

Keywords

Rape, Secondary prevention, Intervention

Brief summary

The purpose of this study is to evaluate whether a brief intervention in video format, that includes education about reactions to assault and modeling of adaptive coping strategies, designed to reduce post assault drug use or abuse and PTSD and shown to recent victims of sexual assault at the time of receipt of post assault medical care is associated with better post-assault outcomes as compared to a comparable length video that includes pleasant imagery and relaxation instruction or standard care.

Detailed description

Post assault outcomes include coping behaviors and PTSD symptoms.

Interventions

BEHAVIORALPPRS

Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.

BEHAVIORALPIRI

Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Seeking medical care after recent sexual assault

Exclusion criteria

* Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury

Design outcomes

Primary

Measure	Time frame	Description
Drug Abuse Screening Test (DAST-10)	6 months	total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months
Alcohol Use Disorders Identification Test (AUDIT)	6 months	Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months
Cigarettes (Estimated Number)	14 days preceding 6 week, 3 month and 6 month follow-up	quantity in 14 days prior to 6 week, 3 month and 6 month follow-up
Amount of Alcohol Use	14 days prior to 6 week, 3 month, 6 month follow-up	estimated number of drinks during the 14 days prior to each follow-up assessment
Marijuana Use Frequency	14 days prior to 6 week, 3 month, 6 month follow-up	Number of days of use within the 14 days prior to follow-up assessment

Secondary

Measure	Time frame	Description
Any Other Illicit Drug Use	14 days prior to 6 week, 3 month, 6 month follow-up	Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up
Non-medical Use of Prescription Drugs Frequency	14 days prior to 6 week, 3 month, 6 month follow-up	Number of days of use within the 14 days prior to follow-up assessment
PTSD Symptom Scale Self-Report (PSS-SR)	2 weeks prior to 6 week, 3 month, 6 month followup	Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.

Countries

United States

Participant flow

Participants by arm

Arm	Count
PPRS (Completing Baseline) Prevention of Post-Sexual Assault Stress	77
PIRI (Completing Baseline) Pleasant Imagery and Relaxation Instruction	77
Standard Care (Completing Baseline) Standard Care Condition completing baseline	79
Total	233

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	23	29	27
Overall Study	technical or eligibility	5	5	2

Baseline characteristics

Characteristic	PIRI (Completing Baseline)	Standard Care (Completing Baseline)	PPRS (Completing Baseline)	Total
Age, Categorical <=18 years	5 Participants	2 Participants	3 Participants	10 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	72 Participants	77 Participants	74 Participants	223 Participants
Age, Continuous	27.99 years STANDARD_DEVIATION 10.77	27.52 years STANDARD_DEVIATION 10.01	26.79 years STANDARD_DEVIATION 8.22	27.43 years STANDARD_DEVIATION 9.7
Region of Enrollment United States	77 participants	79 participants	77 participants	233 participants
Sex: Female, Male Female	77 Participants	79 Participants	77 Participants	233 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 82	0 / 82	0 / 81
serious Total, serious adverse events	2 / 82	0 / 82	0 / 81

Outcome results

Primary

Alcohol Use Disorders Identification Test (AUDIT)

Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months

Time frame: 6 months

Population: Includes only participants with full scale score information at 6 months

Arm	Measure	Value (MEAN)	Dispersion
PPRS Video	Alcohol Use Disorders Identification Test (AUDIT)	7.21 units on a scale	Standard Deviation 8.73
PIRI Video	Alcohol Use Disorders Identification Test (AUDIT)	7.53 units on a scale	Standard Deviation 9.69
Standard Care	Alcohol Use Disorders Identification Test (AUDIT)	8.15 units on a scale	Standard Deviation 7.42

p-value: 0.89ANOVA

Primary

Amount of Alcohol Use

estimated number of drinks during the 14 days prior to each follow-up assessment

Time frame: 14 days prior to 6 week, 3 month, 6 month follow-up

Population: 1 participant with missing data at 6 week follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
PPRS Video	Amount of Alcohol Use	6 Month (n = 38, 41, 42)	10.16 Drinks	Standard Deviation 21.42
PPRS Video	Amount of Alcohol Use	6 Week (n = 54, 48, 51)	15.33 Drinks	Standard Deviation 21.2
PPRS Video	Amount of Alcohol Use	3 Month (n = 48, 44, 43)	8.29 Drinks	Standard Deviation 12.81
PIRI Video	Amount of Alcohol Use	6 Month (n = 38, 41, 42)	10.49 Drinks	Standard Deviation 21.58
PIRI Video	Amount of Alcohol Use	6 Week (n = 54, 48, 51)	13.92 Drinks	Standard Deviation 28.17
PIRI Video	Amount of Alcohol Use	3 Month (n = 48, 44, 43)	14.32 Drinks	Standard Deviation 22.47
Standard Care	Amount of Alcohol Use	6 Month (n = 38, 41, 42)	14.60 Drinks	Standard Deviation 22.62
Standard Care	Amount of Alcohol Use	6 Week (n = 54, 48, 51)	19.90 Drinks	Standard Deviation 43.73
Standard Care	Amount of Alcohol Use	3 Month (n = 48, 44, 43)	11.49 Drinks	Standard Deviation 15.66

p-value: 0.63ANOVA

p-value: 0.25ANOVA

p-value: 0.59ANOVA

Primary

Cigarettes (Estimated Number)

quantity in 14 days prior to 6 week, 3 month and 6 month follow-up

Time frame: 14 days preceding 6 week, 3 month and 6 month follow-up

Population: 1 participant missing 6 week cigarette smoking information

Arm	Measure	Group	Value (MEAN)	Dispersion
PPRS Video	Cigarettes (Estimated Number)	3 Month (n = 48, 44, 43)	54.63 cigarettes	Standard Error 121.22
PPRS Video	Cigarettes (Estimated Number)	6 Week (n = 53, 48, 52)	49.94 cigarettes	Standard Error 80.19
PPRS Video	Cigarettes (Estimated Number)	6 Month (n = 38, 41, 42)	42.68 cigarettes	Standard Error 76.78
PIRI Video	Cigarettes (Estimated Number)	3 Month (n = 48, 44, 43)	67.73 cigarettes	Standard Error 129.01
PIRI Video	Cigarettes (Estimated Number)	6 Week (n = 53, 48, 52)	87.29 cigarettes	Standard Error 141.2
PIRI Video	Cigarettes (Estimated Number)	6 Month (n = 38, 41, 42)	71.71 cigarettes	Standard Error 126.15
Standard Care	Cigarettes (Estimated Number)	6 Week (n = 53, 48, 52)	118.04 cigarettes	Standard Error 114.94
Standard Care	Cigarettes (Estimated Number)	6 Month (n = 38, 41, 42)	84.64 cigarettes	Standard Error 92.67
Standard Care	Cigarettes (Estimated Number)	3 Month (n = 48, 44, 43)	84.47 cigarettes	Standard Error 100.54

p-value: 0.01ANOVA

p-value: 0.48ANOVA

p-value: 0.17ANOVA

Primary

Drug Abuse Screening Test (DAST-10)

total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months

Time frame: 6 months

Population: Only includes participants with complete scale data at 6 months

Arm	Measure	Value (MEAN)	Dispersion
PPRS Video	Drug Abuse Screening Test (DAST-10)	1.97 units on a scale	Standard Deviation 2.65
PIRI Video	Drug Abuse Screening Test (DAST-10)	2.03 units on a scale	Standard Deviation 2.85
Standard Care	Drug Abuse Screening Test (DAST-10)	1.18 units on a scale	Standard Deviation 1.62

p-value: 0.24ANOVA

Primary

Marijuana Use Frequency

Number of days of use within the 14 days prior to follow-up assessment

Time frame: 14 days prior to 6 week, 3 month, 6 month follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
PPRS Video	Marijuana Use Frequency	3 Month (n = 48, 44, 43)	2.75 days of use	Standard Deviation 4.94
PPRS Video	Marijuana Use Frequency	6 Week (n = 54, 48, 52)	1.98 days of use	Standard Deviation 3.85
PPRS Video	Marijuana Use Frequency	6 Month (n = 38, 41, 42)	1.03 days of use	Standard Deviation 2.7
PIRI Video	Marijuana Use Frequency	3 Month (n = 48, 44, 43)	1.39 days of use	Standard Deviation 2.81
PIRI Video	Marijuana Use Frequency	6 Week (n = 54, 48, 52)	2.48 days of use	Standard Deviation 4.52
PIRI Video	Marijuana Use Frequency	6 Month (n = 38, 41, 42)	1.73 days of use	Standard Deviation 3.98
Standard Care	Marijuana Use Frequency	6 Week (n = 54, 48, 52)	2.12 days of use	Standard Deviation 4.42
Standard Care	Marijuana Use Frequency	6 Month (n = 38, 41, 42)	2.90 days of use	Standard Deviation 5.4
Standard Care	Marijuana Use Frequency	3 Month (n = 48, 44, 43)	2.12 days of use	Standard Deviation 4.28

p-value: 0.83ANOVA

p-value: 0.29ANOVA

p-value: 0.13ANOVA

Secondary

Any Other Illicit Drug Use

Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up

Time frame: 14 days prior to 6 week, 3 month, 6 month follow-up

Arm	Measure	Group	Value (NUMBER)
PPRS Video	Any Other Illicit Drug Use	3 Month (n = 48, 42, 43)	4 participants
PPRS Video	Any Other Illicit Drug Use	6 Week (n = 54, 48, 52)	6 participants
PPRS Video	Any Other Illicit Drug Use	6 Month (n = 38, 41, 42)	4 participants
PIRI Video	Any Other Illicit Drug Use	3 Month (n = 48, 42, 43)	3 participants
PIRI Video	Any Other Illicit Drug Use	6 Week (n = 54, 48, 52)	0 participants
PIRI Video	Any Other Illicit Drug Use	6 Month (n = 38, 41, 42)	4 participants
Standard Care	Any Other Illicit Drug Use	6 Week (n = 54, 48, 52)	2 participants
Standard Care	Any Other Illicit Drug Use	6 Month (n = 38, 41, 42)	3 participants
Standard Care	Any Other Illicit Drug Use	3 Month (n = 48, 42, 43)	2 participants

p-value: 0.37Chi-squared

p-value: 0.15Chi-squared

p-value: 0.87Chi-squared

Secondary

Non-medical Use of Prescription Drugs Frequency

Number of days of use within the 14 days prior to follow-up assessment

Time frame: 14 days prior to 6 week, 3 month, 6 month follow-up

Population: 2 participants had missing data at 6 month follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
PPRS Video	Non-medical Use of Prescription Drugs Frequency	3 Month (n = 48, 44, 43)	.81 days of use	Standard Deviation 2.57
PPRS Video	Non-medical Use of Prescription Drugs Frequency	6 Week (n = 54, 48, 52)	1.56 days of use	Standard Deviation 3.96
PPRS Video	Non-medical Use of Prescription Drugs Frequency	6 Month (n = 38, 40, 41)	.61 days of use	Standard Deviation 2.39
PIRI Video	Non-medical Use of Prescription Drugs Frequency	3 Month (n = 48, 44, 43)	.75 days of use	Standard Deviation 2.63
PIRI Video	Non-medical Use of Prescription Drugs Frequency	6 Week (n = 54, 48, 52)	.08 days of use	Standard Deviation 0.35
PIRI Video	Non-medical Use of Prescription Drugs Frequency	6 Month (n = 38, 40, 41)	.40 days of use	Standard Deviation 1.19
Standard Care	Non-medical Use of Prescription Drugs Frequency	6 Week (n = 54, 48, 52)	.54 days of use	Standard Deviation 1.6
Standard Care	Non-medical Use of Prescription Drugs Frequency	6 Month (n = 38, 40, 41)	.10 days of use	Standard Deviation 0.63
Standard Care	Non-medical Use of Prescription Drugs Frequency	3 Month (n = 48, 44, 43)	.16 days of use	Standard Deviation 0.62

p-value: 0.012ANOVA

p-value: 0.31ANOVA

p-value: 0.35ANOVA

Secondary

PTSD Symptom Scale Self-Report (PSS-SR)

Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.

Time frame: 2 weeks prior to 6 week, 3 month, 6 month followup

Population: Only includes those with complete scale score information

Arm	Measure	Group	Value (MEAN)	Dispersion
PPRS Video	PTSD Symptom Scale Self-Report (PSS-SR)	3 Month (n = 45, 42, 43)	23.98 units on a scale	Standard Deviation 11.09
PPRS Video	PTSD Symptom Scale Self-Report (PSS-SR)	6 Week (n = 52, 43, 49)	26.98 units on a scale	Standard Deviation 10.42
PPRS Video	PTSD Symptom Scale Self-Report (PSS-SR)	6 Month (n = 35, 37, 41)	17.66 units on a scale	Standard Deviation 11.83
PIRI Video	PTSD Symptom Scale Self-Report (PSS-SR)	3 Month (n = 45, 42, 43)	23.33 units on a scale	Standard Deviation 13.03
PIRI Video	PTSD Symptom Scale Self-Report (PSS-SR)	6 Week (n = 52, 43, 49)	29.07 units on a scale	Standard Deviation 11.48
PIRI Video	PTSD Symptom Scale Self-Report (PSS-SR)	6 Month (n = 35, 37, 41)	21.65 units on a scale	Standard Deviation 12.8
Standard Care	PTSD Symptom Scale Self-Report (PSS-SR)	6 Week (n = 52, 43, 49)	24.49 units on a scale	Standard Deviation 11.63
Standard Care	PTSD Symptom Scale Self-Report (PSS-SR)	6 Month (n = 35, 37, 41)	19.83 units on a scale	Standard Deviation 12.47
Standard Care	PTSD Symptom Scale Self-Report (PSS-SR)	3 Month (n = 45, 42, 43)	21.70 units on a scale	Standard Deviation 12.56

p-value: 0.15ANOVA

p-value: 0.67ANOVA

p-value: 0.4ANOVA

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026

Prevention of Post Sexual Assault Stress

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Alcohol Use Disorders Identification Test (AUDIT)

Amount of Alcohol Use

Cigarettes (Estimated Number)

Drug Abuse Screening Test (DAST-10)

Marijuana Use Frequency

Any Other Illicit Drug Use

Non-medical Use of Prescription Drugs Frequency

PTSD Symptom Scale Self-Report (PSS-SR)