Emotional Disclosure in HIV

October 9, 2015 updated by: Gail Ironson, University of Miami

Efficacy of an Emotional Disclosure Intervention in HIV

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

283

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33124-2070
        • University of Miami Dept. of Psychology & Behavioral Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in psychological distress
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Gail Ironson, MD, University of Miami Dept. of Psychology & Behavioral Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 25, 2003

First Submitted That Met QC Criteria

August 26, 2003

First Posted (Estimate)

August 27, 2003

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20020511
  • R01AT002035 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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