Treatment of Depression With Massage in HIV

March 5, 2008 updated by: National Center for Complementary and Integrative Health (NCCIH)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Russell E. Poland, PhD, Cedars-Sinai Medical Center
  • Eric Daar, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

April 11, 2002

First Submitted That Met QC Criteria

April 11, 2002

First Posted (Estimate)

April 12, 2002

Study Record Updates

Last Update Posted (Estimate)

March 7, 2008

Last Update Submitted That Met QC Criteria

March 5, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT001047-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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