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Emotional Disclosure in HIV

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ClinicalTrials.gov Identifier: NCT00067704
Recruitment Status : Completed
First Posted : August 27, 2003
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gail Ironson, University of Miami

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Trauma writing Behavioral: Writing about daily events Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Efficacy of an Emotional Disclosure Intervention in HIV
Study Start Date : February 2004
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Trauma writing
Four sessions of writing about traumatic experiences.
 Behavioral: Trauma writing
Sham Comparator: Writing about daily events
Four sessions of writing about their daily experiences.
 Behavioral: Writing about daily events


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Decrease in psychological distress [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Increase in CD4 T-lymphocytes [ Time Frame: 1 year ]
  2. Decrease in the number of HIV symptoms [ Time Frame: 1 year ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067704


Locations
United States, Florida
University of Miami Dept. of Psychology & Behavioral Medicine
Coral Gables, Florida, United States, 33124-2070
Sponsors and Collaborators
University of Miami
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Gail Ironson, MD University of Miami Dept. of Psychology & Behavioral Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Gail Ironson, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00067704     History of Changes
Other Study ID Numbers: 20020511
R01AT002035 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2003    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Gail Ironson, University of Miami:
Complementary Therapies

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