Back to resultsUnilateral Massage as a Potential Treatment for Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bi-lateral massage
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Unilateral Massage, Depression
Eligibility Criteria
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).
Sites / Locations
- University of Arizona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Left-Sided Massage
Right-Sided Massage
Bi-Lateral Massage
Arm Description
Unilateral massage on the left side of the body.
Unilateral massage on the right side of the body.
Traditional massage on the back of the body.
Outcomes
Primary Outcome Measures
Non-invasive EEG recording
EEG recording using an electrode cap and electrode gel connected to an EEG Machine to record brain activity.
Secondary Outcome Measures
PANAS (Postitive and Negative Affect Schedule)Questionnaire
To obtain mood ratings before and after the UMI.
Full Information
NCT ID
NCT01937897
First Posted
August 30, 2013
Last Updated
February 3, 2014
Sponsor
University of Arizona
1. Study Identification
Unique Protocol Identification Number
NCT01937897
Brief Title
Unilateral Massage as a Potential Treatment for Depression
Official Title
Unilateral Massage as a Potential Treatment for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Unilateral Massage, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Left-Sided Massage
Arm Type
Experimental
Arm Description
Unilateral massage on the left side of the body.
Arm Title
Right-Sided Massage
Arm Type
Active Comparator
Arm Description
Unilateral massage on the right side of the body.
Arm Title
Bi-Lateral Massage
Arm Type
Sham Comparator
Arm Description
Traditional massage on the back of the body.
Intervention Type
Other
Intervention Name(s)
Bi-lateral massage
Other Intervention Name(s)
Massage on the left side of the body.
Intervention Description
Unilateral massage on the left side of the body.
Primary Outcome Measure Information:
Title
Non-invasive EEG recording
Description
EEG recording using an electrode cap and electrode gel connected to an EEG Machine to record brain activity.
Time Frame
Collected 4 minutes after the unilateral massage has ended.
Secondary Outcome Measure Information:
Title
PANAS (Postitive and Negative Affect Schedule)Questionnaire
Description
To obtain mood ratings before and after the UMI.
Time Frame
Collected immediately following the unilateral massage.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Raison, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clemens Janssen, MS
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
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Unilateral Massage as a Potential Treatment for Depression
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