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Efficacy of Group Intervention to Reduce Stress Symptoms

Primary Purpose

Stress Disorders, Post-Traumatic, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV Skills-based Prevention
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorders, Post-Traumatic focused on measuring Complementary Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard of Care, Wait-List Control

HIV Prevention

HIV Prevention plus Trauma

Arm Description

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.

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.

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.

Outcomes

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.
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
Mediation effect on trauma symptoms on HIV-related risk behavior

Secondary Outcome Measures

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.

Full Information

First Posted
January 25, 2008
Last Updated
March 16, 2020
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00611338
Brief Title
Efficacy of Group Intervention to Reduce Stress Symptoms
Official Title
Efficacy of Group Intervention to Reduce Stress Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2006 (Actual)
Primary Completion Date
July 31, 2012 (Actual)
Study Completion Date
July 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, HIV Infections
Keywords
Complementary Therapies

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care, Wait-List Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HIV Prevention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HIV Prevention plus Trauma
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIV Skills-based Prevention
Primary Outcome Measure Information:
Title
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.
Description
unprotected insertive and receptive sexual intercourse
Time Frame
immediate post intervention, 3 months, 6 months, and 12 months
Title
To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone
Description
Mediation effect on trauma symptoms on HIV-related risk behavior
Time Frame
immediate post intervention, 3 months, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
To determine whether key variables moderate the intervention's effects.
Description
Gender, age, ethnicity, or psychological distress (e.g. , depression, anxiety) may interact with the intervention to affect risky sexual or drug-related behavior.
Time Frame
immediate post intervention, 3 months, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Gore-Felton Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Efficacy of Group Intervention to Reduce Stress Symptoms

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