Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

Duquesne University

Status: Completed

Conditions: Adverse Effects; HIV Infections

Treatments: Behavioral: Cognitive-behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00696839

#08-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

1

No Intervention group

Description:

Usual care (adherence education)

2

Experimental group

Description:

Usual care and Cognitive Behavioral Therapy sessions

Treatment:

Behavioral: Cognitive-behavioral therapy