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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00696839
Other study ID # #08-17
Secondary ID
Status Completed
Phase N/A
First received June 11, 2008
Last updated March 1, 2010
Start date September 2008
Est. completion date August 2009

Study information

Verified date March 2010
Source Duquesne University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date August 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Duquesne University Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Side effect symptoms measured by visual analogue scales study start, 30 days, 60 days, 90 days No
Secondary Health status by SF-36 study start, 30 days, 60 days, 90 days No
Secondary Adherence by visual analogue scale study start, 30 days, 60 days, 90 days No
Secondary CD4 lymphocyte count study start, 90 days No
Secondary Serum HIV level study start, 90 days No
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