DepressionNCT01937897
Unilateral Massage as a Potential Treatment for Depression
A study testing Bi-lateral massage in people with Depression, run by University of Arizona at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Bi-lateral massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Left-Handed subjects, persons suffering acute or chronic mental illnesses and chronic illnesses (including autoimmune illnesses).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression
- Being tested
- Bi-lateral massage
- Keywords
- Unilateral Massage, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-lateral massageOther
Also called Massage on the left side of the body.
Unilateral massage on the left side of the body.
| Study group | Role | What they receive |
|---|---|---|
| Left-Sided Massage | Experimental | Unilateral massage on the left side of the body. Receives: Other: Bi-lateral massage |
| Right-Sided Massage | Active comparator | Unilateral massage on the right side of the body. Receives: Other: Bi-lateral massage |
| Bi-Lateral Massage | Sham comparator | Traditional massage on the back of the body. Receives: Other: Bi-lateral massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive EEG recording
EEG recording using an electrode cap and electrode gel connected to an EEG Machine to record brain activity.
Measured: Collected 4 minutes after the unilateral massage has ended.
Secondary outcomes (1)
PANAS (Postitive and Negative Affect Schedule)Questionnaire
To obtain mood ratings before and after the UMI.
Measured: Collected immediately following the unilateral massage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Raison, MD, Principal investigator, University of ArizonaClemens Janssen, MS, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937897
- Sponsor's protocol ID
- 13-0441
- Status last verified
- Feb 2014
- First submitted
- 30 Aug 2013
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Massage as a Potential Treatment for Depression
- ClinicalTrials.gov ID
- NCT01937897
- Acronym / sponsor ID
- 13-0441
- Conditions
- Depression
- Keywords
- Unilateral Massage, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Left-Sided Massage | Experimental | Other: Bi-lateral massageUnilateral massage on the left side of the body. |
| Right-Sided Massage | Active comparator | Other: Bi-lateral massageUnilateral massage on the right side of the body. |
| Bi-Lateral Massage | Sham comparator | Other: Bi-lateral massageTraditional massage on the back of the body. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Left-Handed subjects, persons suffering acute or chronic mental illnesses and chronic illnesses (including autoimmune illnesses).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi-lateral massageAlso: Massage on the left side of the body.Unilateral massage on the left side of the body. | Other | Bi-Lateral Massage, Left-Sided Massage, Right-Sided Massage |
Primary outcome
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.
1 secondary outcome
PANAS (Postitive and Negative Affect Schedule)Questionnaire
Time frame: Collected immediately following the unilateral massage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Raison, MD principal investigator
University of Arizona
Clemens Janssen, MS principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-lateral massage in people with Depression, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive EEG recording (time frame: Collected 4 minutes after the unilateral massage has ended.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.