Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections, Adverse Effects

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Usual care (adherence education) | |
| Experimental: 2<br>Usual care and Cognitive Behavioral Therapy sessions | Behavioral: Cognitive-behavioral therapy<br>* 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.<br>* Other names: Reframing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect symptoms measured by visual analogue scales |  | study start, 30 days, 60 days, 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior Therapy, Anti-Retroviral Agents, Relaxation, Clinical Nursing Research, Complementary Therapies