Emotional Disclosure in HIV

University of Miami

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Writing about daily events; Behavioral: Trauma writing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00067704

R01AT002035 (U.S. NIH Grant/Contract)

20020511

Details and patient eligibility

About

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.

Enrollment: 283 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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283 participants in 2 patient groups

Trauma writing

Experimental group

Description:

Four sessions of writing about traumatic experiences.

Treatment:

Behavioral: Trauma writing

Writing about daily events

Sham Comparator group

Description:

Four sessions of writing about their daily experiences.

Treatment:

Behavioral: Writing about daily events