Treatment of Depression With Massage in HIV

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00033852
First received: April 11, 2002
Last updated: March 5, 2008
Last verified: March 2008
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Treatment of Depression With Massage in HIV

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 90
Study Start Date: April 2002
Estimated Study Completion Date: May 2004
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 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033852

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Investigators
Principal Investigator: Russell E. Poland, PhD Cedars-Sinai Medical Center
Investigator: Eric Daar, MD Cedars-Sinai Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00033852     History of Changes
Other Study ID Numbers: R21 AT001047-01
Study First Received: April 11, 2002
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
complementary therapies
Depression
HIV
Massage Therapy
Alternative Treatments

Additional relevant MeSH terms:
Depression
Depressive Disorder
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014