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OpenTrials
Completed

NCT Number: NCT00067704

Emotional Disclosure 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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Dept. of Psychology & Behavioral Medicine

Coral Gables, Florida, 33124-2070, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma writing

Behavioral

Writing about daily events

Behavioral

Primary outcomes

  1. Decrease in psychological distress

    Time frame: 1 year

Secondary outcomes

  1. Increase in CD4 T-lymphocytes

    Time frame: 1 year

  2. Decrease in the number of HIV symptoms

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Efficacy of an Emotional Disclosure Intervention in HIV

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2003
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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