Prevention of Post Sexual Assault Stress

NCT ID: NCT01430624

Last Updated: 2016-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Post assault outcomes include coping behaviors and PTSD symptoms.

Conditions

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Drug Use Drug Abuse Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PPRS video

Prevention of post sexual assault stress

Group Type EXPERIMENTAL

PPRS

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

PIRI

Intervention Type BEHAVIORAL

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

Standard care

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PPRS

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

Intervention Type BEHAVIORAL

PIRI

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Seeking medical care after recent sexual assault

Exclusion Criteria

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

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heidi Resnick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

North Memorial Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37795783 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37286883 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31622944 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31242340 (View on PubMed)

Other Identifiers

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R01DA023099

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA023099

Identifier Type: NIH

Identifier Source: org_study_id

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