Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects - Full Text View

Sponsors and Collaborators:	Duquesne University Milton S. Hershey Medical Center
Information provided by:	Duquesne University
ClinicalTrials.gov Identifier:	NCT00696839

Purpose

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.

Condition	Intervention
HIV Infections Adverse Effects	Behavioral: Cognitive-behavioral therapy

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment
Official Title:	Clinical Trial Of Cognitive-Behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients

Further study details as provided by Duquesne University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696839

Contacts

Contact: Eric Doerfler, PhD(c)	717-948-6513	red1012@psu.edu
Contact: Linda Goodfellow, PhD	412-396-6548	goodfellow@duq.edu

Locations

United States, Pennsylvania
Penn State Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Robert E Doerfler, PhD(c) 717-948-6513 red1012@psu.edu

Sponsors and Collaborators

Duquesne University

Milton S. Hershey Medical Center

Investigators

Principal Investigator:

Eric Doerfler, PhD(c)

Duquesne University School of Nursing

More Information

Responsible Party:	Duquesne University ( R. Eric Doerfler )
Study ID Numbers:	#08-17
Study First Received:	June 11, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00696839
Health Authority:	United States: Institutional Review Board

Keywords provided by Duquesne University:

Behavior Therapy
Anti-Retroviral Agents
Relaxation
Clinical Nursing Research
Complementary Therapies

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009