Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

This study has been completed.

Sponsor:

Collaborator:

Milton S. Hershey Medical Center

Information provided by:

Duquesne University

ClinicalTrials.gov Identifier:

NCT00696839

First received: June 11, 2008

Last updated: March 1, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2008

Last Updated Date

March 1, 2010

Start Date ^ICMJE

September 2008

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Side effect symptoms measured by visual analogue scales [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00696839 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Health status by SF-36 [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]
Adherence by visual analogue scale [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]
CD4 lymphocyte count [ Time Frame: study start, 90 days ] [ Designated as safety issue: No ]
Serum HIV level [ Time Frame: study start, 90 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

Official Title ^ICMJE

Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients

Brief Summary

The hypothesis is that participants in the intervention group will experience fewer/less intense side effects from anti-HIV medications, if they receive training sessions on the use of guided imagery, relaxation, and reframing of the medication-taking experience. Such training is not part of the usual care of HIV patients.

Detailed Description

HIV patients on antiretroviral medications, who are suffering from pain, nausea, anxiety, or fatigue will be randomly assigned to either the usual care for an HIV patient, which is an educational program about the medications, or an intervention program, which includes both the educational program and three sessions with a psychologist. The sessions will help participants understand their concerns about the medications and will teach relaxation techniques and guided imagery to help participants reduce discomforts associated with the medications. All patients will continue to receive the usual care from their medical providers. The main measures are the measured frequency and intensity of the symptoms under study; secondary measures examine medication adherence, CD4 counts, and virus levels. Control measures include the number of doses of side effect medications taken in each group, and the number of relaxation/imagery sessions practiced privately by participants in the intervention group.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

HIV Infections
Adverse Effects

Intervention ^ICMJE

Behavioral: Cognitive-behavioral therapy

3 sessions of CBT: introduction of CBT, training in relaxation and guided imagery, and troubleshooting/closure. 50 minute sessions with an HIV-experienced treating psychologist in Beck-type CBT. Participants will be given an audiorecording of the 2nd session to be used in private home practice, as desired.

Other Names:

Relaxation techniques
Progressive muscle relaxation
Guided imagery
Reframing

Study Arm (s)

No Intervention: 1
Usual care (adherence education)
Experimental: 2
Usual care and Cognitive Behavioral Therapy sessions

Intervention: Behavioral: Cognitive-behavioral therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Participants currently taking antiretroviral medications for HIV
Participants suffer from one or more: nausea, pain, fatigue, anxiety

Exclusion Criteria:

Non-English speaking/reading
Pregnant or planning to become pregnant within 3 months
Any severe health problem that would prevent participation (e.g., opportunistic infection requiring hospitalization)
Substance abuse preventing active participation in care

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00696839

Other Study ID Numbers ^ICMJE

#08-17

Has Data Monitoring Committee

Yes

Responsible Party

R. Eric Doerfler, Duquesne University

Study Sponsor ^ICMJE

Duquesne University

Collaborators ^ICMJE

Milton S. Hershey Medical Center

Investigators ^ICMJE

Principal Investigator:

Eric Doerfler, PhD(c)

Duquesne University School of Nursing

Information Provided By

Duquesne University

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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