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 Alternative Medicine (NCCAM).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00067704
First received: August 25, 2003
Last updated: April 21, 2008
Last verified: April 2008

August 25, 2003
April 21, 2008
February 2004
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Complete list of historical versions of study NCT00067704 on ClinicalTrials.gov Archive Site
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Emotional Disclosure in HIV
Efficacy of an Emotional Disclosure Intervention in HIV

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.

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Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
HIV Infections
Behavioral: Emotional disclosure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
April 2008
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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
Both
18 Years to 65 Years
No
Contact: Gail Ironson, MD 305-284-5299 gironson@aol.com
United States
 
NCT00067704
R01 AT002035, IronsonG
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Gail Ironson, MD University of Miami Dept. of Psychology & Behavioral Medicine
National Center for Complementary and Alternative Medicine (NCCAM)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP