|
Treatment of Depression with Massage in HIV Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Treatment of Depression with Massage in HIV conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Treatment of Depression with Massage in HIV Clinical research trials and Treatment of Depression with Massage in HIV health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Treatment of Depression with Massage in HIV. Treatment of Depression with Massage in HIV Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Treatment of Depression with Massage in HIV clinical trial. Participants oftentimes recieve the most expert healthcare available for their Treatment of Depression with Massage in HIV condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Treatment of Depression with Massage in HIV  Treatment of Depression with Massage in HIV
Treatment of Depression with Massage in HIV
For Condition: Acquired Immunodeficiency Syndrome,HIV Infections,Depression
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - HIV Seropositive - Depression as defined by SCID-I with HAM-D score of ³15 (21-item scale) - On stable neuropsychiatric, analgesic and antiretroviral regimen for >30 days and no plans to modify therapy during the ensuing 4 months. Exclusion Criteria: - Unable to provide informed consent (e.g.sever cognitive impairment) - New opportunistic infection, malignancies, or acute hospitalizations during the past 30 days - Suicidal ideation - Psychosis or bipolar disorder - Taking any growth hormone or adrenocorticoid preparations - Massage therapy or new alternative medicine use in preceeding 30 days - History of intolerance to massage or contraindication to massage (e.g. skin lesions that prevent direct contact by the therapist)
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
EricDaar, , Cedars-Sinai Medical Center
Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Sareen Kevork 310-423-7978
Additional Information:
Study ID Numbers: 1 R21 AT01047-01;
Study Start Date: April 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033852
Other Hiv Infections Studies:
1. Analysis of Immune Responses to HIV Vaccines
2. Safety and Survival of Genetically Modified White Blood Cells in HIV-infected Persons - A Study in Identical Twin Pairs
3. AIDS-Associated Heart Disease -- Incidence and Etiology
4. A Pilot Study of Adherence to Oral Medication and Health Beliefs of Adolescents with HIV and their Mothers
5. Pulmonary Complications of HIV Infection Study (PACS)
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Treatment of Depression with Massage in HIV
|
|
|
|
|
|
|
|
