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Emotional Disclosure in HIV

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00067704
First Posted: August 27, 2003
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gail Ironson, University of Miami
August 25, 2003
August 27, 2003
October 14, 2015
February 2004
November 2012   (Final data collection date for primary outcome measure)
Decrease in psychological distress [ Time Frame: 1 year ]
Not Provided
Complete list of historical versions of study NCT00067704 on ClinicalTrials.gov Archive Site
  • Increase in CD4 T-lymphocytes [ Time Frame: 1 year ]
  • Decrease in the number of HIV symptoms [ Time Frame: 1 year ]
Not Provided
Not Provided
Not Provided
 
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
 
Completed
283
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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00067704
20020511
R01AT002035 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
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