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Efficacy of Group Intervention to Reduce Stress Symptoms

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ClinicalTrials.gov Identifier: NCT00611338
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Cheryl Gore-Felton, 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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic HIV Infections Behavioral: HIV Skills-based Prevention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Prevention
Official Title: Efficacy of Group Intervention to Reduce Stress Symptoms
Actual Study Start Date : August 1, 2006
Actual Primary Completion Date : July 31, 2012
Actual Study Completion Date : July 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard of Care, Wait-List Control
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
Active Comparator: HIV Prevention
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
Active Comparator: HIV Prevention plus Trauma
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



Primary Outcome Measures :
  1. 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. [ Time Frame: immediate post intervention, 3 months, 6 months, and 12 months ]
    unprotected insertive and receptive sexual intercourse

  2. To determine if decreasing trauma-related stress symptoms improves HIV risk reduction behavior above a standard HIV risk reduction intervention alone [ Time Frame: immediate post intervention, 3 months, 6 months, and 12 months ]
    Mediation effect on trauma symptoms on HIV-related risk behavior


Secondary Outcome Measures :
  1. To determine whether key variables moderate the intervention's effects. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611338


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Cheryl Gore-Felton Ph.D. Stanford University

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Responsible Party: Cheryl Gore-Felton, Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT00611338     History of Changes
Other Study ID Numbers: SU-12192007-944
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

Keywords provided by Cheryl Gore-Felton, Stanford University:
Complementary Therapies

Additional relevant MeSH terms:
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HIV Infections
Stress Disorders, Post-Traumatic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders