Emotional Disclosure in HIV
Efficacy of an Emotional Disclosure Intervention in HIV
2 other identifiers
interventional
283
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Feb 2004
Longer than P75 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2003
CompletedFirst Posted
Study publicly available on registry
August 27, 2003
CompletedStudy Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedOctober 14, 2015
October 1, 2015
8.8 years
August 25, 2003
October 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease in psychological distress
1 year
Secondary Outcomes (2)
Increase in CD4 T-lymphocytes
1 year
Decrease in the number of HIV symptoms
1 year
Study Arms (2)
Trauma writing
EXPERIMENTALFour sessions of writing about traumatic experiences.
Writing about daily events
SHAM COMPARATORFour sessions of writing about their daily experiences.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Dept. of Psychology & Behavioral Medicine
Coral Gables, Florida, 33124-2070, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail Ironson, MD
University of Miami Dept. of Psychology & Behavioral Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2003
First Posted
August 27, 2003
Study Start
February 1, 2004
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
October 14, 2015
Record last verified: 2015-10