Emotional Disclosure in HIV

NCT ID: NCT00067704

Last Updated: 2015-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Trauma writing

Four sessions of writing about traumatic experiences.

Group Type EXPERIMENTAL

Trauma writing

Intervention Type BEHAVIORAL

Writing about daily events

Four sessions of writing about their daily experiences.

Group Type SHAM_COMPARATOR

Writing about daily events

Intervention Type BEHAVIORAL

Interventions

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Trauma writing

Intervention Type BEHAVIORAL

Writing about daily events

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Gail Ironson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gail Ironson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami Dept. of Psychology & Behavioral Medicine

Locations

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University of Miami Dept. of Psychology & Behavioral Medicine

Coral Gables, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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R01AT002035

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20020511

Identifier Type: -

Identifier Source: org_study_id

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