Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

Not Applicable

Completed

• Conditions: HIV Infections; Adverse Effects
• Interventions: Behavioral: Cognitive-behavioral therapy

• Registration Number: NCT00696839
• Lead Sponsor: Duquesne University

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 Timeline

• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Study Start: 2008-09
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-01
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Cognitive-behavioral therapy	Usual care and Cognitive Behavioral Therapy sessions

Primary Outcome Measures

Name	Time	Method
Side effect symptoms measured by visual analogue scales	study start, 30 days, 60 days, 90 days

Secondary Outcome Measures

Name	Time	Method
Health status by SF-36	study start, 30 days, 60 days, 90 days
Adherence by visual analogue scale	study start, 30 days, 60 days, 90 days
CD4 lymphocyte count	study start, 90 days
Serum HIV level	study start, 90 days

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States