Efficacy of Group Intervention to Reduce Stress Symptoms

NCT00611338 | Completed

• 1 other identifier: SU-12192007-944
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; HIV Infections

Keywords

Complementary Therapies

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• To determine whether key variables moderate the intervention's effects.

  immediate post intervention, 3 months, 6 months and 12 months

Study Arms (3)

Standard of Care, Wait-List Control

ACTIVE COMPARATOR

Participants received standard medical care, which in most clinics included informational brochures provided by physicians and clinic staff. Participants were given HIV prevention information and materials in English and Spanish and were provided referrals for services. Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months. At the end of the 12-month assessment, the wait-list control participants participated in the Trauma + HIV group arm.

Behavioral: HIV Skills-based Prevention

HIV Prevention

ACTIVE COMPARATOR

Eight, 90 minute group sessions. Three of the sessions focused on health education (e.g., medication adherence, nutrition, exercise) and five focused on HIV prevention skills (e.g., condom skills, communication, social support). Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months. At the end of the 12-month assessment, the participants in this arm were given the option to receive the 3 trauma-focused sessions from the Trauma + HIV group arm.

Behavioral: HIV Skills-based Prevention

HIV Prevention plus Trauma

ACTIVE COMPARATOR

The same format as the HIV Prevention arm with eight, 90 minute group sessions. The participants received the same five HIV prevention skills sessions along with three sessions that focused on reducing trauma-related stress (e.g., breathing training, relaxation exercises, grounding exercises, coping, trauma-related triggers). Each individual completed assessments at immediate post intervention, 3-, 6-, and 12- months.

Behavioral: HIV Skills-based Prevention

Interventions

HIV Skills-based Prevention BEHAVIORAL

HIV Prevention; HIV Prevention plus Trauma; Standard of Care, Wait-List Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; HIV Infections

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Cheryl Gore-Felton Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study investigators were blind to the condition of study participants until all intervention sessions and assessments were completed. The data were coded to mask the intervention conditions for all data analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 8, 2008
• Study Start: August 1, 2006
• Primary Completion: July 31, 2012
• Study Completion: July 31, 2012
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

US (1)