Efficacy of Group Intervention to Reduce Stress Symptoms - Full Text View

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00611338

Purpose

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.

Condition	Intervention	Phase
Stress Disorders, Post-Traumatic HIV Infections	Behavioral: HIV Skills-based Prevention	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Group Intervention to Reduce Stress Symptoms

Resource links provided by NLM:

MedlinePlus related topics: AIDS Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	290
Study Start Date:	July 2006
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611338

Contacts

Contact: Susanne Lee, MPH

(650) 724-7025

susannel@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Susanne Lee, MPH 650-724-7025 susannel@stanford.edu
Principal Investigator: Cheryl Gore-Felton Ph.D.
Sub-Investigator: Cheryl Koopman

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Cheryl Gore-Felton Ph.D.

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University School of Medicine ( Cheryl Gore-Felton Ph.D. )
Study ID Numbers:	SU-12192007-944
Study First Received:	January 25, 2008
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00611338 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:

Complementary Therapies

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Stress
Infection
Stress Disorders, Traumatic
Immunologic Deficiency Syndromes

Virus Diseases
Pathologic Processes
Anxiety Disorders
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Stress Disorders, Post-Traumatic
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010