Back to resultsEmotional Disclosure in HIV
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma writing
Writing about daily events
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Complementary Therapies
Eligibility 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
Sites / Locations
- University of Miami Dept. of Psychology & Behavioral Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Trauma writing
Writing about daily events
Arm Description
Four sessions of writing about traumatic experiences.
Four sessions of writing about their daily experiences.
Outcomes
Primary Outcome Measures
Decrease in psychological distress
Secondary Outcome Measures
Increase in CD4 T-lymphocytes
Decrease in the number of HIV symptoms
Full Information
NCT ID
NCT00067704
First Posted
August 25, 2003
Last Updated
October 9, 2015
Sponsor
University of Miami
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00067704
Brief Title
Emotional Disclosure in HIV
Official Title
Efficacy of an Emotional Disclosure Intervention in HIV
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Complementary Therapies
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
283 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trauma writing
Arm Type
Experimental
Arm Description
Four sessions of writing about traumatic experiences.
Arm Title
Writing about daily events
Arm Type
Sham Comparator
Arm Description
Four sessions of writing about their daily experiences.
Intervention Type
Behavioral
Intervention Name(s)
Trauma writing
Intervention Type
Behavioral
Intervention Name(s)
Writing about daily events
Primary Outcome Measure Information:
Title
Decrease in psychological distress
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Increase in CD4 T-lymphocytes
Time Frame
1 year
Title
Decrease in the number of HIV symptoms
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Ironson, MD
Organizational Affiliation
University of Miami Dept. of Psychology & Behavioral Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Dept. of Psychology & Behavioral Medicine
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33124-2070
Country
United States
12. IPD Sharing Statement
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Emotional Disclosure in HIV
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