Emotional Disclosure in HIV

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Gail Ironson, University of Miami
ClinicalTrials.gov Identifier:
NCT00067704
First received: August 25, 2003
Last updated: October 9, 2015
Last verified: October 2015
  Purpose
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 Intervention
HIV Infections
Behavioral: Trauma writing
Behavioral: Writing about daily events

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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Decrease in psychological distress [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 283
Study Start Date: February 2004
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

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

Responsible Party: Gail Ironson, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00067704     History of Changes
Other Study ID Numbers: 20020511  R01AT002035 
Study First Received: August 25, 2003
Last Updated: October 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 25, 2016