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

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 |
- Decrease in psychological distress [ Time Frame: 1 year ]
- Increase in CD4 T-lymphocytes [ Time Frame: 1 year ]
- Decrease in the number of HIV symptoms [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Florida | |
University of Miami Dept. of Psychology & Behavioral Medicine | |
Coral Gables, Florida, United States, 33124-2070 |
Principal Investigator: | Gail Ironson, MD | University of Miami Dept. of Psychology & Behavioral Medicine |
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 |