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

January 25, 2008
December 11, 2009
July 2006
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
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.
Complete list of historical versions of study NCT00611338 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Efficacy of Group Intervention to Reduce Stress Symptoms
Efficacy of Group Intervention to Reduce Stress Symptoms

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Stress Disorders, Post-Traumatic
  • HIV Infections
Behavioral: HIV Skills-based Prevention
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
290
August 2011
August 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Susanne Lee, MPH (650) 724-7025 susannel@stanford.edu
United States
 
NCT00611338
SU-12192007-944
Not Provided
Cheryl Gore-Felton Ph.D., Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Cheryl Gore-Felton Ph.D. Stanford University
Stanford University
December 2009

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