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Emotional Disclosure in HIV

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Center for Complementary and Integrative Health (NCCIH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
ClinicalTrials.gov Identifier:
NCT00067704
First received: August 25, 2003
Last updated: April 21, 2008
Last verified: April 2008
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Efficacy of an Emotional Disclosure Intervention in HIV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Integrative Health (NCCIH)
Investigators
Principal Investigator: Gail Ironson, MD University of Miami Dept. of Psychology & Behavioral Medicine
  More Information

No publications provided

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

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Complementary Therapies

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
 Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on February 26, 2015