Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-08-31

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.

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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.

Conditions

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HIV Infections Adverse Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Usual care (adherence education)

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Usual care and Cognitive Behavioral Therapy sessions

Group Type EXPERIMENTAL

Cognitive-behavioral therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Relaxation techniques Progressive muscle relaxation Guided imagery Reframing

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No