Efficacy of Group Intervention to Reduce Stress Symptoms

HIV Infections Clinical Trial

Official title:

Efficacy of Group Intervention to Reduce Stress Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611338
• Other study ID #: SU-12192007-944
• Status: Completed
• Phase: N/A
• Start date: August 1, 2006
• Est. completion date: July 31, 2012

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: July 31, 2012
• Est. primary completion date: July 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• HIV Skills-based Prevention

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	unprotected insertive and receptive sexual intercourse	immediate post intervention, 3 months, 6 months, and 12 months
Primary	To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone	Mediation effect on trauma symptoms on HIV-related risk behavior	immediate post intervention, 3 months, 6 months, and 12 months
Secondary	To determine whether key variables moderate the intervention's effects.	Gender, age, ethnicity, or psychological distress (e.g. , depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.	immediate post intervention, 3 months, 6 months and 12 months