Acute Intervention to Reduce Distress Following Sexual As... | NCT01622855

Studies
Acute Intervention to Reduce Distress Following Sexual Assault

NCT01622855

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Apr 22, 2015Estimated

Enrollment

442Actual

Phase

Phase 1Phase 2

Conditions

Drug Use
Drug Abuse
Posttraumatic Stress Disorder

Interventions

PPRS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA011158	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1997

Primary Completion Date

Sep 2005Actual

Completion Date

Sep 2005Actual

First Submitted Date

Jun 15, 2012

First Submission Date that Met QC Criteria

Jun 15, 2012

First Posted Date

Jun 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2015

Last Update Posted Date

Apr 22, 2015Estimated

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study was to evaluate whether a brief intervention in video format delivered in the post assault medical exam setting and including education about assault reactions and instruction in and modeling of successful coping strategies would reduce post assault drug use or abuse and PTSD symptoms as compared to standard care.

Detailed Description

The intervention being evaluated was shown at the time of the post assault medical exam and includes two main components: preparation for the medical exam; and information about and modelling of coping strategies that may help women cope in the aftermath of assault. The intervention content is delivered via video. Intervention and standard care groups were compared with regard to measures of substance use and abuse and symptoms of PTSD and other potentially comorbid problems including symptoms of depression or other anxiety.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

442Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PPRS video	Experimental	Prevention of post sexual assault stress	Behavioral: PPRS
Standard care	No Intervention	Receipt of standard services

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PPRS	Behavioral	Video including psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.	PPRS video

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of specific drug use	Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups	14 days

Secondary Outcomes

Measure	Description	Time Frame
Specific Drug Abuse	Criteria for DSM-IV substance abuse based on structured interview	1.5, 3, 6 months
PSS-SR	Measure of PTSD symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Seeking medical care after recent sexual assault

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heidi Resnick, Ph.D.	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29412	United States

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided