Unilateral Massage as a Potential Treatment for Depression
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Jul 2013
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 30, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 4, 2014
February 1, 2014
7 months
August 30, 2013
February 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-invasive EEG recording
EEG recording using an electrode cap and electrode gel connected to an EEG Machine to record brain activity.
Collected 4 minutes after the unilateral massage has ended.
Secondary Outcomes (1)
PANAS (Postitive and Negative Affect Schedule)Questionnaire
Collected immediately following the unilateral massage.
Study Arms (3)
Left-Sided Massage
EXPERIMENTALUnilateral massage on the left side of the body.
Right-Sided Massage
ACTIVE COMPARATORUnilateral massage on the right side of the body.
Bi-Lateral Massage
SHAM COMPARATORTraditional massage on the back of the body.
Interventions
Unilateral massage on the left side of the body.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Left-Handed subjects, persons suffering acute or chronic mental illnesses and chronic illnesses (including autoimmune illnesses).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona
Tucson, Arizona, 85724, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Raison, MD
University of Arizona
- PRINCIPAL INVESTIGATOR
Clemens Janssen, MS
University of Arizona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2013
First Posted
September 10, 2013
Study Start
July 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
February 4, 2014
Record last verified: 2014-02