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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Prevention
Official Title:	Efficacy of an Emotional Disclosure Intervention in HIV

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Gail Ironson, University of Miami:

Primary Outcome Measures:

Decrease in psychological distress [ Time Frame: 1 year ]

Secondary Outcome Measures:

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


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)
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

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 ( US NIH Grant/Contract Award Number )
Study First Received:	August 25, 2003
Last Updated:	October 9, 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

ClinicalTrials.gov processed this record on June 28, 2017

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