Massage: Neuroimaging and Correlates of Response - 6-week Study

August 25, 2026 updated by: Becky Kinkead, University of Utah

Neuroimaging and Correlates of Response

This study will help find out if massage and touch therapies change brain activity and reduce the symptoms of anxiety. Massage therapy has well known health benefits. This study will help to learn if these therapies reduce the symptoms of anxiety by changing brain activity. Participation in the study will last about 8 weeks. This is a randomized research study. "Randomized" means that participants will be assigned to a study group by chance, like flipping a coin. Participants will be randomized into one of two study groups, and will have an equal chance of being placed in one of the groups: - Swedish massage therapy twice per week for 6 weeks - Light touch therapy twice per week for 6 weeks At each study, the study staff ask about life stressors, medical health, medicine use, and illicit substance use over the past week. The study uses magnetic resonance imaging (MRI) as well as functional MRI (fMRI) to look at the structure and activation of the brain. Participants will undergo two brain scanning sessions, one before the first intervention and one immediately after the last Swedish massage or light touch therapy. The scans will last approximately 45 minutes. During the brain scanning sessions, information on heart rate, blood pressure, temperature and breathing will also be collected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a two-arm, randomized, single masked study investigating the effects of twice per week for 6 weeks Swedish massage therapy (SMT) vs. a light touch (LT) control on brain activity, assessments, and autonomic function in non-psychiatric control subjects. The Primary Objective is to identify brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the neutral/fearful/angry faces task in normal control subjects. The secondary objective is to correlate changes in autonomic measures with resting state fMRI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female
  • aged ≥ 18 and < 65 years old
  • Medically stable
  • Psychiatrically healthy as demonstrated by a structured clinical interview that elicits no previous or current Axis I psychopathology
  • Ability to lie prone or supine for one hour at a time, given the nature of the massage intervention
  • Subjects must have a permanent domicile
  • Subjects must be able to comply with the research protocol
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

  • Current (within 3 months of screening visit) nicotine use, illicit drug use, or long-term medication use that, in the opinion of the investigator, could alter the results of the study
  • Pregnancy (per participant report, pregnancy testing not done for study)
  • Usually is asleep during the daytime (ie due to Working third-shift), or any other behaviors that routinely disrupt normal diurnal (daily) rhythms
  • Current (past month) rigorous dieting (defined as <1200 calories per day for ≥2 consecutive days)
  • In the month before screening visit, excessive regular use of alcohol, as defined by either of the following, twice a month or more often: (a drink is one 5 ounce glass of wine or equivalent) a. ingestion of 5 drinks or more in a 2 hour period b. ingestion of 7 drinks or more in a 24 hour period
  • At screening visit, CURRENTLY using any of the following interventions because of psychological distress (for example, for treatment of anxiety and/or other psychiatric condition). (These types of treatments are also prohibited during the study period.) a. participating in psychotherapy b. participating in CAM (complementary and alternative medical interventions) c. taking medication(s) (for example anxiolytics, antidepressants, and other psychotropic medications)
  • Participant meets criteria for current suicidal or homicidal ideation
  • Subjects who have massages on a regular basis. Regular massage usage will be defined as receiving on average 4 or more massages/year for the last 5 years
  • Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem
  • History of head injury or neurological disorder, that in the investigator's opinion would impact the data or preclude safe and successful completion of the study - History of cancer that required chemotherapy and/or radiation treatment.
  • General contraindication to MRI - Because MRI uses a very strong magnet, subjects cannot have metals in their bodies or certain medical conditions. Subjects cannot have a cardiac pacemaker; hearing aid; any other implant metal in their body or eyes, including pins, screws, shrapnel, plates, teeth braces, or dentures. Subjects cannot have tattoos on their head, such as eyeliner or other permanent makeup, as they may make it impossible to get clear and usable images.
  • Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol, or complete the study.
  • Current participation in another research study (excluding large natural cohort trials such as 'All of Us')

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Swedish Massage Therapy
The therapist uses non-aromatic cream to facilitate making long strokes over the body. Swedish massage is done with the subject covered by a sheet, a technique called "draping." One part of the body is uncovered, massaged, and then re-draped before moving to another part. The primary techniques used in the research protocol therapy are effleurage, petrissage, kneading, tapotement and thumb friction. These techniques are performed in a very precise, carefully elaborated manner. The session starts with the subject fully draped in a prone position on the massage table and after approximately 22 minutes the subject is instructed to turn to the supine position. Finally, the therapist moves to the head area of the subject, begins working on the shoulders, neck and head using effleurage and thumb friction, and concludes by using light tapotement on the head. The total time for the entire massage is 45 minutes. Subjects randomized to SMT will undergo two sessions per week for 6-weeks.
Other: Swedish Massage Therapy
The therapist uses non-aromatic cream to facilitate making long strokes over the body. Swedish massage is done with the subject covered by a sheet, a technique called "draping." One part of the body is uncovered, massaged, and then re-draped before moving to another part. The primary techniques used in the research protocol therapy are effleurage, petrissage, kneading, tapotement and thumb friction. These techniques are performed in a very precise, carefully elaborated manner. The session starts with the subject fully draped in a prone position on the massage table and after approximately 22 minutes the subject is instructed to turn to the supine position. Finally, the therapist moves to the head area of the subject, begins working on the shoulders, neck and head using effleurage and thumb friction, and concludes by using light tapotement on the head. The total time for the entire massage is 45 minutes. Subjects randomized to SMT will undergo two sessions per week for 6-weeks.
Active Comparator: Light Touch Control
The Light Touch Control protocol entails the same duration and sequence of procedures as the massage protocol, except that the therapist employs only light-touch hand placement on the subject's body. This condition isolates the effect of the mechanical intervention of SMT. Subjects randomized to LT will undergo two sessions per week for 6-weeks.
Other: Light Touch Control
The Light Touch Control protocol entails the same duration and sequence of procedures as the massage protocol, except that the therapist employs only light-touch hand placement on the subject's body. This condition isolates the effect of the mechanical intervention of SMT. Subjects randomized to LT will undergo two sessions per week for 6-weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in rsFC
Time Frame: 6-weeks
Change in resting state functional activity in brain networks activated by SMT vs. LT using resting state fMRI in healthy non-psychiatric control subjects will be calculated at week 6, after the last intervention relative to baseline.
6-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in neuronal connectivity in response to fearful/angry faces task
Time Frame: 6-weeks
pre-to-post-intervention change in neuronal connectivity in response to fearful/angry faces task during fMRI.
6-weeks
Correlation of changes in autonomic measures (heart rate variability, heart rate, pulse) with resting state neuronal functional connectivity in response to fearful/angry faces task during fMRI
Time Frame: Week 6
Change in autonomic activity (heart rate variability, heart rate, pulse) will be correlated with changes in resting state functional connectivity in response to the fearful/angry faces task during fMRI.
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Becky Kinkead, PhD, Utah, University of

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB_00155218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will maximize the appropriate sharing of scientific data generated from the conducted research, consistent with privacy, security, informed consent, and proprietary issues. Data management and sharing will be addressed in the informed consent process, including communicating with prospective participants how their scientific data are expected to be used and shared.

IPD Sharing Time Frame

Following peer-reviewed publication of our results, de-identified materials and data generated in the course of this project will made available upon reasonable request.

IPD Sharing Access Criteria

Scientific data will be made accessible in a timely manner for use by the research community and the broader public. Specifically, scientific data will be made accessible as soon as possible, and no later than the time of an associated publication. We will consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, journal policies) as guidance for the minimum time frame scientific data should be made available. However, we will make scientific data available for as long as it is useful for the larger research community, institutions, and/or the broader public.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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