Adverse Effects, HIV Infections
Conditions
Keywords
Behavior Therapy, Anti-Retroviral Agents, Relaxation, Clinical Nursing Research, Complementary Therapies
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.
Interventions
BEHAVIORALCognitive-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.
Sponsors
Milton S. Hershey Medical Center
Duquesne University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side effect symptoms measured by visual analogue scales | study start, 30 days, 60 days, 90 days |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed