NCT00696839

Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Duquesne University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Adverse Effects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2008-06-13
• Last updated: 2010-03-02

Locations

1 site across 1 country: United States