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Emotional Disclosure in HIV

Efficacy of an Emotional Disclosure Intervention in HIV

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00067704
Enrollment
283
Registered
2003-08-27
Start date
2004-02-29
Completion date
2012-11-30
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Complementary Therapies

Brief 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.

Interventions

BEHAVIORALTrauma writing
BEHAVIORALWriting about daily events

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Decrease in psychological distress1 year

Secondary

MeasureTime frame
Increase in CD4 T-lymphocytes1 year
Decrease in the number of HIV symptoms1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026