Clinical trial NCT00696839: Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects
Official title: Clinical Trial Of Cognitive-behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Adverse Effects
Keywords: Behavior Therapy
Anti-Retroviral Agents
Relaxation
Clinical Nursing Research
Complementary Therapies
Lead sponsor: Duquesne University
Sponsor class: OTHER
Collaborators: name: Milton S. Hershey Medical Center
First posted: 2008-06-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Side effect symptoms measured by visual analogue scales
timeFrame: study start, 30 days, 60 days, 90 days
Secondary outcomes:
measure: Health status by SF-36
timeFrame: study start, 30 days, 60 days, 90 days
measure: Adherence by visual analogue scale
timeFrame: study start, 30 days, 60 days, 90 days
measure: CD4 lymphocyte count
timeFrame: study start, 90 days
measure: Serum HIV level
timeFrame: study start, 90 days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Duquesne University School of Nursing
name: Eric Doerfler, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References: