Efficacy of Group Intervention to Reduce Stress Symptoms

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic; HIV Infections

• Registration Number: NCT00611338
• Lead Sponsor: Stanford University

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

This is a risk reduction intervention for adults who are living with HIV, are experiencing trauma-related stress symptoms, and are at risk for HIV transmission. By first treating trauma symptoms, the effects of a skills-building HIV risk reduction intervention for adults experiencing trauma-related symptoms such as hyperarousal, dissociation, and avoidance will be enhanced. This is based on a model the proposes trauma-related symptoms have direct effects on HIV risk behavior. Therefore, the successful treatment of trauma-related symptoms will facilitate HIV risk behavior change.

Study Timeline

• Study Start: 2006-08-01
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-02-08
• Primary Completion: 2012-07-31
• Study Completion: 2012-07-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	immediate post intervention, 3 months, 6 months, and 12 months	unprotected insertive and receptive sexual intercourse
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone	immediate post intervention, 3 months, 6 months, and 12 months	Mediation effect on trauma symptoms on HIV-related risk behavior

Secondary Outcome Measures

Name	Time	Method
To determine whether key variables moderate the intervention's effects.	immediate post intervention, 3 months, 6 months and 12 months	Gender, age, ethnicity, or psychological distress (e.g. , depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States