Emotional Disclosure in HIV

This study has been completed.
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gail Ironson, University of Miami
ClinicalTrials.gov Identifier:
First received: August 25, 2003
Last updated: October 9, 2015
Last verified: October 2015

August 25, 2003
October 9, 2015
February 2004
November 2012   (final data collection date for primary outcome measure)
Decrease in psychological distress [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00067704 on ClinicalTrials.gov Archive Site
  • Increase in CD4 T-lymphocytes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Decrease in the number of HIV symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
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Emotional Disclosure in HIV
Efficacy of an Emotional Disclosure Intervention in HIV
The specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for HIV infected individuals. The goal of the current study is to test the efficacy of emotional disclosure through writing in patients with HIV infection. We will compare emotional disclosure through writing about traumatic experiences (experimental intervention) to a control intervention (writing about emotionally neutral topics). [Note that HIV RNA viral load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and medication adherence are the 6 primary outcome variables.
Not Provided
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
HIV Infections
  • Behavioral: Trauma writing
  • Behavioral: Writing about daily events
  • Experimental: Trauma writing
    Four sessions of writing about traumatic experiences.
    Intervention: Behavioral: Trauma writing
  • Sham Comparator: Writing about daily events
    Four sessions of writing about their daily experiences.
    Intervention: Behavioral: Writing about daily events
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2012
November 2012   (final data collection date for primary outcome measure)

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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
20020511, R01AT002035
Gail Ironson, University of Miami
University of Miami
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Gail Ironson, MD University of Miami Dept. of Psychology & Behavioral Medicine
University of Miami
October 2015

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