Emotional Disclosure in HIV | NCT00067704

Studies
Emotional Disclosure in HIV

NCT00067704

Sponsor

University of Miami

Status

Completed

Last Update Posted

Oct 14, 2015Estimated

Enrollment

283Actual

Phase

Not Applicable

Conditions

HIV Infections

Interventions

Trauma writing
Writing about daily events

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AT002035	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Aug 25, 2003

First Submission Date that Met QC Criteria

Aug 26, 2003

First Posted Date

Aug 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2015

Last Update Posted Date

Oct 14, 2015Estimated

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.](streamdown:incomplete-link)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

283Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trauma writing	Experimental	Four sessions of writing about traumatic experiences.	Behavioral: Trauma writing
Writing about daily events	Sham Comparator	Four sessions of writing about their daily experiences.	Behavioral: Writing about daily events

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trauma writing	Behavioral		Trauma writing
Writing about daily events

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease in psychological distress		1 year

Secondary Outcomes

Measure	Description	Time Frame
Increase in CD4 T-lymphocytes		1 year
Decrease in the number of HIV symptoms		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gail Ironson, MD	University of Miami Dept. of Psychology & Behavioral Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami Dept. of Psychology & Behavioral Medicine		Coral Gables	Florida	33124-2070	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided