Stress-Reducing Interventions in HIV+ Patients: Pilot

NCT ID: NCT00599599

Last Updated: 2009-03-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-02-28

Brief Summary

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The primary aim of this project is to examine the efficacy of prolonged exposure (PE) therapy at reducing HIV-related PTSD symptoms, increasing adherence to antiretroviral medication regimens, and increasing health-related quality of life (QOL) in HIV+ patients.

Detailed Description

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HIV+ patients will be randomized to receive either PE therapy (up to 18 possible sessions) or weekly symptom monitoring (described below) and will complete measures of PTSD, adherence, and QOL pre- and post-intervention and at 3- and 6-month follow-up assessments. Secondary analyses will examine the impact of the intervention on disorders commonly comorbid with PTSD (i.e., anxiety, mood, and substance abuse/dependence disorders).

Conditions

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Stress Disorders, Post-Traumatic HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Prolonged Exposure Therapy.

Group Type EXPERIMENTAL

Prolonged Exposure Therapy

Intervention Type BEHAVIORAL

Participants will meet with a therapist twice a week for 5 weeks to complete the therapy. If the therapist and participant feel more sessions are needed, an additional 8 sessions will be provided.

2

Weekly monitoring/Waitlist Control Group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prolonged Exposure Therapy

Participants will meet with a therapist twice a week for 5 weeks to complete the therapy. If the therapist and participant feel more sessions are needed, an additional 8 sessions will be provided.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Must be HIV+
* Must meet PTSD diagnostic criteria
* Must be taking HIV medications
* Must be able to read and write in English

Exclusion Criteria

* Current or previous diagnosis of schizophrenia, any current diagnosis with psychotic features, or current suicidal ideation
* Being in a current abusive relationship or ongoing intimate relationship with one's assailant
* Mental retardation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Summa Health System

OTHER

Sponsor Role collaborator

Kent State University

OTHER

Sponsor Role lead

Responsible Party

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Kent State University

Principal Investigators

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Douglas L Delahanty, PhD

Role: PRINCIPAL_INVESTIGATOR

Kent State University

Locations

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Violet's Cupboard

Akron, Ohio, United States

Site Status

AIDS Taskforce of Greater Cleveland

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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NIMH, 1 R34 MH071201-01A1

Identifier Type: -

Identifier Source: secondary_id

R34MH071201-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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