Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Unilateral Massage as a Potential Treatment for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01937897
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date  ICMJE August 30, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date February 4, 2014
Study Start Date  ICMJE July 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
Non-invasive EEG recording [ Time Frame: Collected 4 minutes after the unilateral massage has ended. ]
EEG recording using an electrode cap and electrode gel connected to an EEG Machine to record brain activity.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01937897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
PANAS (Postitive and Negative Affect Schedule)Questionnaire [ Time Frame: Collected immediately following the unilateral massage. ]
To obtain mood ratings before and after the UMI.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Unilateral Massage as a Potential Treatment for Depression
Official Title  ICMJE Unilateral Massage as a Potential Treatment for Depression
Brief Summary In depression, EEG studies have shown frontal asymmetry with relatively lower activity in the left hemisphere. In this study a moderate pressure massage will be conducted by a trained professional on one of the following conditions: the right side of the body, the left side of the body, or both sides of the body (a traditional massage on the back of the body) while EEG measurements of brain activity are recorded and mood ratings are obtained.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Other: Bi-lateral massage
Unilateral massage on the left side of the body.
Other Name: Massage on the left side of the body.
Study Arms  ICMJE
  • Experimental: Left-Sided Massage
    Unilateral massage on the left side of the body.
    Intervention: Other: Bi-lateral massage
  • Active Comparator: Right-Sided Massage
    Unilateral massage on the right side of the body.
    Intervention: Other: Bi-lateral massage
  • Sham Comparator: Bi-Lateral Massage
    Traditional massage on the back of the body.
    Intervention: Other: Bi-lateral massage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2013)
15
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Medically and mentally healthy, right-handed participants will be eligible for participating in this study. The age range for enrollment in the study is not restricted by any variables but will be set between 18 and 50 years of age.

Exclusion Criteria:

  • Left-Handed subjects, persons suffering acute or chronic mental illnesses and chronic illnesses (including autoimmune illnesses).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01937897
Other Study ID Numbers  ICMJE 13-0441
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charles Raison, MD University of Arizona
Principal Investigator: Clemens Janssen, MS University of Arizona
PRS Account University of Arizona
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP