NCT01937897

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

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable depression

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

August 30, 2013

Last Update Submit

February 3, 2014

Conditions

Keywords

Unilateral MassageDepression

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

EXPERIMENTAL

Unilateral massage on the left side of the body.

Other: Bi-lateral massage

Right-Sided Massage

ACTIVE COMPARATOR

Unilateral massage on the right side of the body.

Other: Bi-lateral massage

Bi-Lateral Massage

SHAM COMPARATOR

Traditional massage on the back of the body.

Other: Bi-lateral massage

Interventions

Unilateral massage on the left side of the body.

Also known as: Massage on the left side of the body.
Bi-Lateral MassageLeft-Sided MassageRight-Sided Massage

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Charles Raison, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR
  • Clemens Janssen, MS

    University of Arizona

    PRINCIPAL INVESTIGATOR

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

Locations