Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033852
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2002-04-11
Brief Title:
Treatment of Depression With Massage in HIV
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Treatment of Depression With Massage in HIV
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 111 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
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 111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None