Efficacy of Group Intervention to Reduce Stress Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Stanford University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Stanford University

ClinicalTrials.gov Identifier:

NCT00611338

First received: January 25, 2008

Last updated: December 11, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

January 25, 2008

Last Updated Date

December 11, 2009

Start Date ^ICMJE

July 2006

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post -intervention 3, 6, and 12 months after the group intervention sessions. [ Designated as safety issue: No ]
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone post -intervention 3, 6, and 12 months after the group intervention sessions.

Change History

Complete list of historical versions of study NCT00611338 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine whether key variables moderate the intervention's effects. For instance gender, age, ethnicity, or psychological distress (e.g. , depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior. [ Designated as safety issue: No ]
To determine whether key variables moderate the intervention's effects. [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To determine whether key variables moderate the intervention's effects. For instance gender, age, ethnicity, or psychological distress (e.g. , depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.
To determine whether there is evidence that the theoretical mediator variables mediate the intervention's effect on outcomes.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy of Group Intervention to Reduce Stress Symptoms

Official Title ^ICMJE

Efficacy of Group Intervention to Reduce Stress Symptoms

Brief Summary

This research study will examine the usefulness of groups in reducing stress and helping individuals with HIV to stay healthy and avoid problems associated with sexually transmitted diseases. We hope to discover whether being in a group is effective in reducing stress-related symptoms and promoting healthy behaviors.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Stress Disorders, Post-Traumatic
HIV Infections

Intervention ^ICMJE

Behavioral: HIV Skills-based Prevention

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

290

Estimated Completion Date

August 2011

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:Must be 18 years or older, must be HIV-positive, report engaging in behavior that could put them at risk for HIV transmission in the past three months, report experiencing one or more trauma-related symptoms within the past three months.

Exclusion Criteria:Exclusion criteria include the presence of gross cognitive impairment, dementia, acute psychosis, or severe physical impairment that would preclude adequate comprehension of assessment material and participation in small group intervention.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Susanne Lee, MPH

(650) 724-7025

susannel@stanford.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00611338

Other Study ID Numbers ^ICMJE

SU-12192007-944

Has Data Monitoring Committee

Not Provided

Responsible Party

Cheryl Gore-Felton Ph.D., Stanford University School of Medicine

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Cheryl Gore-Felton Ph.D.

Stanford University

Information Provided By

Stanford University

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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