We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Group Intervention to Reduce Stress Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00611338
Recruitment Status : Unknown
Verified December 2009 by Stanford University.
Recruitment status was:  Recruiting
First Posted : February 8, 2008
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic HIV Infections Behavioral: HIV Skills-based Prevention Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Group Intervention to Reduce Stress Symptoms
Study Start Date : July 2006
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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.
  2. 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 ]

Secondary Outcome Measures :
  1. 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.
  2. To determine whether key variables moderate the intervention's effects. [ Time Frame: 15 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cheryl Gore-Felton Ph.D., Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00611338     History of Changes
Other Study ID Numbers: SU-12192007-944
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

Keywords provided by Stanford University:
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Stress Disorders, Post-Traumatic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders