NCT00033852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2002

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
Last Updated

March 7, 2008

Status Verified

March 1, 2008

First QC Date

April 11, 2002

Last Update Submit

March 5, 2008

Conditions

Acquired Immunodeficiency SyndromeHIV InfectionsDepression

Keywords

complementary therapiesDepressionHIVMassage TherapyAlternative Treatments

Interventions

Massage TherapyPROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV InfectionsDepression

Interventions

Massage

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Russell E. Poland, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

  • Eric Daar, MD

    Cedars-Sinai Medical Center

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 11, 2002

First Posted

April 12, 2002

Study Start

April 1, 2002

Study Completion

May 1, 2004

Last Updated

March 7, 2008

Record last verified: 2008-03

Locations

US(1)