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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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Group Intervention to Reduce Stress Symptoms

Resource links provided by NLM:

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

Keywords provided by Stanford University:
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013