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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA023099 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
Post assault outcomes include coping behaviors and PTSD symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPRS video | Experimental | Prevention of post sexual assault stress |
|
| PIRI video | Active Comparator | Pleasant imagery and relaxation instruction |
|
| Standard care | No Intervention | Treatment as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPRS | Behavioral | Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Abuse Screening Test (DAST-10) | total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months | 6 months |
| Alcohol Use Disorders Identification Test (AUDIT) | Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months | 6 months |
| Cigarettes (Estimated Number) | quantity in 14 days prior to 6 week, 3 month and 6 month follow-up | 14 days preceding 6 week, 3 month and 6 month follow-up |
| Amount of Alcohol Use | estimated number of drinks during the 14 days prior to each follow-up assessment | 14 days prior to 6 week, 3 month, 6 month follow-up |
| Marijuana Use Frequency | Number of days of use within the 14 days prior to follow-up assessment | 14 days prior to 6 week, 3 month, 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days prior to 6 week, 3 month, 6 month follow-up |
| Non-medical Use of Prescription Drugs Frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Resnick, Ph.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55404 | United States | ||
| North Memorial Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37795783 | Derived | O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2. | |
| 37286883 | Derived | Walsh K, Gilmore AK, Jaffe AE, Frazier P, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. A preliminary examination of sexual and physical victimization 6 months after recent rape. Arch Womens Ment Health. 2023 Aug;26(4):495-501. doi: 10.1007/s00737-023-01335-y. Epub 2023 Jun 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | PIRI Video | Pleasant imagery and relaxation instruction PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam. |
| FG002 | Standard Care | Treatment as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PPRS (Completing Baseline) | Prevention of Post-Sexual Assault Stress |
| BG001 | PIRI (Completing Baseline) | Pleasant Imagery and Relaxation Instruction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Only includes participants with complete scale data at 6 months | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
6 months
Cause of death and cause of hospitalization unknown
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PPRS | Prevention of Post-Sexual Assault Stress |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment | unanticipated, unlikely/unrelated to study - no information about cause, identified over course of study and not related to study procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heidi Resnick, Ph.D. | Medical University of South Carolina | 843-792-2945 | resnickh@musc.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| PIRI | Behavioral | Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam. |
|
Number of days of use within the 14 days prior to follow-up assessment
| 14 days prior to 6 week, 3 month, 6 month follow-up |
| 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. | 2 weeks prior to 6 week, 3 month, 6 month followup |
| Minneapolis |
| Minnesota |
| 55422 |
| United States |
| 31622944 | Derived | Walsh K, Gilmore AK, Schumacher JA, Coffey SF, Frazier PA, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. Post-sexual assault cigarette smoking: Findings from a randomized clinical trial of a video-based intervention. Addict Behav. 2020 Jan;100:106121. doi: 10.1016/j.addbeh.2019.106121. Epub 2019 Sep 5. |
| 31242340 | Derived | Gilmore AK, Walsh K, Frazier P, Ledray L, Acierno R, Ruggiero KJ, Kilpatrick DG, Resnick HS. Prescription Opioid Misuse After a Recent Sexual Assault: A Randomized Clinical Trial of a Video Intervention. Am J Addict. 2019 Sep;28(5):376-381. doi: 10.1111/ajad.12922. Epub 2019 Jun 26. |
| BG002 | Standard Care (Completing Baseline) | Standard Care Condition completing baseline |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Standard Care | Treatment as usual |
|
|
|
| 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 | Includes only participants with full scale score information at 6 months | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Primary | Cigarettes (Estimated Number) | quantity in 14 days prior to 6 week, 3 month and 6 month follow-up | 1 participant missing 6 week cigarette smoking information | Posted | Mean | Standard Error | cigarettes | 14 days preceding 6 week, 3 month and 6 month follow-up |
|
|
|
|
| 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 | Posted | Number | participants | 14 days prior to 6 week, 3 month, 6 month follow-up |
|
|
|
|
| Primary | Amount of Alcohol Use | estimated number of drinks during the 14 days prior to each follow-up assessment | 1 participant with missing data at 6 week follow-up | Posted | Mean | Standard Deviation | Drinks | 14 days prior to 6 week, 3 month, 6 month follow-up |
|
|
|
|
| Primary | Marijuana Use Frequency | Number of days of use within the 14 days prior to follow-up assessment | Posted | Mean | Standard Deviation | days of use | 14 days prior to 6 week, 3 month, 6 month follow-up |
|
|
|
|
| Secondary | Non-medical Use of Prescription Drugs Frequency | Number of days of use within the 14 days prior to follow-up assessment | 2 participants had missing data at 6 month follow-up | Posted | Mean | Standard Deviation | days of use | 14 days prior to 6 week, 3 month, 6 month follow-up |
|
|
|
|
| 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. | Only includes those with complete scale score information | Posted | Mean | Standard Deviation | units on a scale | 2 weeks prior to 6 week, 3 month, 6 month followup |
|
|
|
|
| 2 |
| 82 |
| 0 |
| 82 |
| EG001 | PIRI | Pleasant Imagery and Relaxation Instruction | 0 | 82 | 0 | 82 |
| EG002 | Standard Care Condition | Standard Care Condition | 0 | 81 | 0 | 81 |
|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Unlikely/unrelated to study. |
|
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|
| 6 Month (n = 38, 41, 42) |
|
| .48 |
3 month comparison |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA | .17 | 6 month comparison | 2-Sided | No | Superiority or Other |
|
| 6 Month (n = 38, 41, 42) |
|
df = 2, 135 |
| .15 |
3 month comparison |
| 2-Sided |
| No |
| Superiority or Other |
| Chi-squared | df = 2, 121 | .87 | 6 month comparison | 2-Sided | No | Superiority or Other |
|
| 6 Month (n = 38, 41, 42) |
|
df = 2, 132 |
| .25 |
3 month comparison |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA | df = 2, 118 | .59 | 6 month comparison | 2-Sided | No | Superiority or Other |
|
| 6 Month (n = 38, 41, 42) |
|
df = 2, 132 |
| .29 |
3 month comparison |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA | df = 2, 118 | .13 | 6 month comparison | 2-Sided | No | Superiority or Other |
|
| 6 Month (n = 38, 40, 41) |
|
df = 2, 132 |
| .31 |
3 month comparison |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA | df = 2,116 | .35 | 6 month comparison | 2-Sided | No | Superiority or Other |
|
| 6 Month (n = 35, 37, 41) |
|
df = 2, 127 |
| .67 |
3 month comparison |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA | df = 2, 110 | .40 | 6 month comparison | 2-Sided | No | Superiority or Other |