Emotional Disclosure in HIV

This study is currently recruiting participants.

Verified by National Center for Complementary and Alternative Medicine (NCCAM), April 2008

First Received: August 25, 2003 Last Updated: April 21, 2008 History of Changes

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00067704

Purpose

Due to longer lifespans as a result of antiretroviral therapy, persons with HIV now face the longer-term issue of living with chronic illness. Persons with HIV must deal with not just the distress of chronic illness, but also have higher incidences of abuse, depression, and other life stresses/trauma.

These negative factors have been shown in previous research to have a detrimental impact on immune changes and disease progression in HIV infection.

Research in both normal and chronically ill adults has shown that medical symptoms and cellular immune response may improve when traumatic events are disclosed through writing.

Condition	Intervention	Phase
HIV Infections	Behavioral: Emotional disclosure	Phase I Phase II

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of an Emotional Disclosure Intervention in HIV

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	200
Study Start Date:	February 2004
Estimated Study Completion Date:	April 2008

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

18-65 years of age inclusive
At least 8 years of formal education
Literate
Fluent in English

All of the following three must apply:

No active Category C HIV AIDS-defining symptoms
CD4 T-lymphocyte count between 150-499
Viral load >1000

Exclusion Criteria

Less than 8 years formal education
Illiterate or non-English speaking
Active systemic diseases that would interfere with participation
Current alcohol or substance dependence
Planned change in HIV medication in the next 6 months, or recent change in past 2 months
Introduction of antidepressant medication within 30 days of study start
Current psychological counseling, cognitive behavior therapy, support group or other psychological therapy, or plans to start any of the above
Diagnosis of PTSD or major depression
Unable to attend at least 4 treatment sessions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067704

Contacts

Contact: Gail Ironson, MD

305-284-5299

gironson@aol.com

Locations

United States, Florida
University of Miami Dept. of Psychology & Behavioral Medicine	Recruiting
Coral Gables, Florida, United States, 33124-2070
Contact: Gail Ironson, MD 305-284-5299 gironson@aol.com
Principal Investigator: Gail Ironson, MD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Gail Ironson, MD

University of Miami Dept. of Psychology & Behavioral Medicine

More Information

No publications provided

Study ID Numbers:	R01 AT002035, IronsonG
Study First Received:	August 25, 2003
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00067704 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Complementary Therapies

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009