Emotional Disclosure in HIV

HIV Infections Clinical Trial

Official title:

Efficacy of an Emotional Disclosure Intervention in HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067704
• Other study ID #: 20020511
• Secondary ID: R01AT002035
• Status: Completed
• Phase: N/A
• First received: August 25, 2003
• Last updated: October 9, 2015
• Start date: February 2004
• Est. completion date: November 2012

Study information

• Verified date: October 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Trauma writing

• Writing about daily events

Locations

Country	Name	City	State
United States	University of Miami Dept. of Psychology & Behavioral Medicine	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in psychological distress		1 year	No
Secondary	Increase in CD4 T-lymphocytes		1 year	No
Secondary	Decrease in the number of HIV symptoms		1 year	No