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| Name | Class |
|---|---|
| Milton S. Hershey Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Usual care (adherence education) | |
| 2 | Experimental | Usual care and Cognitive Behavioral Therapy sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect symptoms measured by visual analogue scales | study start, 30 days, 60 days, 90 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Doerfler, PhD(c) | Duquesne University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D012064 | Relaxation Therapy |
| D001326 | Autogenic Training |
| D019018 | Imagery, Psychotherapy |
| D000088686 | Cognitive Restructuring |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
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|
| study start, 90 days |
| Serum HIV level | study start, 90 days |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D006990 | Hypnosis |