Unilateral Massage as a Potential Treatment for Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01937897
First received: August 30, 2013
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Depression
Other: Bi-lateral massage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Unilateral Massage as a Potential Treatment for Depression

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Non-invasive EEG recording [ Time Frame: Collected 4 minutes after the unilateral massage has ended. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Collected immediately following the unilateral massage. ] [ Designated as safety issue: No ]
    To obtain mood ratings before and after the UMI.


Enrollment: 12
Study Start Date: July 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Left-Sided Massage
Unilateral massage on the left side of the body.
Other: Bi-lateral massage
Unilateral massage on the left side of the body.
Other Name: Massage on the left side of the body.
Active Comparator: Right-Sided Massage
Unilateral massage on the right side of the body.
Other: Bi-lateral massage
Unilateral massage on the left side of the body.
Other Name: Massage on the left side of the body.
Sham Comparator: Bi-Lateral Massage
Traditional massage on the back of the body.
Other: Bi-lateral massage
Unilateral massage on the left side of the body.
Other Name: Massage on the left side of the body.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937897

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Charles Raison, MD University of Arizona
Principal Investigator: Clemens Janssen, MS University of Arizona
  More Information

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01937897     History of Changes
Other Study ID Numbers: 13-0441
Study First Received: August 30, 2013
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Unilateral Massage
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014