| June 11, 2008 |
| September 9, 2008 |
| September 2008 |
| February 2009 (final data collection date for primary outcome measure) |
| Side effect symptoms measured by visual analogue scales [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00696839 on ClinicalTrials.gov Archive Site |
- Health status by SF-36 [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]
- Adherence by visual analogue scale [ Time Frame: study start, 30 days, 60 days, 90 days ] [ Designated as safety issue: No ]
- CD4 lymphocyte count [ Time Frame: study start, 90 days ] [ Designated as safety issue: No ]
- Serum HIV level [ Time Frame: study start, 90 days ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Trial of Cognitive Behavioral Therapy to Reduce Antiretroviral Therapy Side Effects |
| Clinical Trial Of Cognitive-Behavioral Therapy To Reduce Antiretroviral Side Effects In HIV Patients |
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. |
| |
| Interventional |
| Supportive Care, Randomized, Open Label, Parallel Assignment |
- HIV Infections
- Adverse Effects
|
| Behavioral: Cognitive-behavioral therapy |
- No Intervention: Usual care (adherence education)
- Experimental: Usual care and Cognitive Behavioral Therapy sessions
|
| |
| |
| Recruiting |
| 30 |
| February 2009 |
| February 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00696839 |
| R. Eric Doerfler, Duquesne University |
| #08-17 |
| Duquesne University |
| Milton S. Hershey Medical Center |
| Principal Investigator: |
Eric Doerfler, PhD(c) |
Duquesne University School of Nursing |
|
|
| Duquesne University |
| June 2008 |
