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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00033852 |
The purpose of this study is to determine the effect of massage therapy on depression, quality of life and plasma cortisol levels in subjects with advanced HIV disease.
Condition | Intervention | Phase |
---|---|---|
Acquired Immunodeficiency Syndrome HIV Infections Depression |
Procedure: Massage Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Depression With Massage in HIV |
Estimated Enrollment: | 90 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | May 2004 |
This is a study to assess the usefulness of massage therapy for treatment of depression and improvement in the quality of life in patients with HIV. This study will define the clinical and biologic response to massage therapy in patients with HIV and depression who are clinically stable and on a fixed medical regimen. Depression is a co-morbid condition in individuals with advanced HIV disease and has a negative impact on quality of life. Depression in HIV-infected patients also has been associated with a decrease in adherence to medications and progression of clinical disease. While pharmacologic therapy for depression have resulted in variable success in managing this problem, it is associated with an increase in the number of medications that these patients are required to take, potential for additional drug-drug interactions, and many adverse events. In patients with advanced stage HIV disease, palliative care is often a priority and identifying new treatment modalities that do not require additional medications while improve clinical symptoms and overall quality of life is of the utmost importance. Pilot studies with massage therapy have been performed in HIV-infected and uninfected individuals. These studies have shown a reduction in depression scores in HIV-uninfected subjects. In HIV-infected patients, massage therapy has been shown to improve quality of life measures and decrease plasma cortisol levels.
The specific aims of this proposal are 1) to determine the effect of massage therapy on depression in subjects with advanced HIV disease, 2) to investigate the effect of massage therapy on quality of life in subjects with advanced HIV disease, and 3) to investigate the effect of massage therapy on plasma cortisol levels in subjects with advanced HIV disease. This study will randomize advanced stage HIV-infected subjects with depression in a 1:1:1 manner to massage therapy, "sham massage" or no physical intervention. The massage and "sham massage" groups will be treated for one hour, twice per week, for 8 weeks. All enrolled subjects will have depression measured (Hamilton Depression Scale) at baseline, weeks 1, 2, 4, 6 and 8, and quality of life (SF-36), and pain assessments (Gracely Pain Scale) at baseline, weeks 4 and 8. In addition, 24-hour urine free cortisol, lymphocyte subsets and HIV RNA measurements will be assessed at baseline and weeks 4 and 8. This will be a rigorously controlled clinical trial using validated measures to assess the clinical (depression and quality of life), and biologic (cortisol levels) effect of massage therapy on subjects with advanced stage HIV disease and clinical depression.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 |
Principal Investigator: | Russell E. Poland, PhD | Cedars-Sinai Medical Center |
Investigator: | Eric Daar, MD | Cedars-Sinai Medical Center |
Study ID Numbers: | R21 AT001047-01 |
Study First Received: | April 11, 2002 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00033852 |
Health Authority: | United States: Federal Government |
complementary therapies Depression HIV Massage Therapy Alternative Treatments |
Virus Diseases Sexually Transmitted Diseases, Viral Depression Mental Disorders HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Mood Disorders Depressive Disorder Retroviridae Infections Immunologic Deficiency Syndromes Behavioral Symptoms |
RNA Virus Infections Pathologic Processes Disease Slow Virus Diseases |
Immune System Diseases Syndrome Lentivirus Infections Infection |