Healthy ControlNCT07190326
Massage: Neuroimaging and Correlates of Response - 6-week Study
A study testing Swedish Massage Therapy in people with Healthy Control, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Control
- What is being tested?
- Swedish Massage Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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')
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Mental Health Institute
Salt Lake City, Utah, 84108
Becky Kinkead, PhD, 801-587-8626, becky.kinkead@hsc.utah.edu
Rachel Douglas, BS, 801-587-2811, rachel.douglas@hsc.utah.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Control
- Being tested
- Swedish Massage Therapy, Light Touch Control
- Keywords
- massage, magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish Massage TherapyOther
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.
Light Touch ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Swedish Massage Therapy | Experimental | 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. Receives: Other: Swedish Massage Therapy |
| Light Touch Control | Active comparator | 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. Receives: Other: Light Touch Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in rsFC
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.
Measured: 6-weeks
Secondary outcomes (2)
Change in neuronal connectivity in response to fearful/angry faces task
pre-to-post-intervention change in neuronal connectivity in response to fearful/angry faces task during fMRI.
Measured: 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
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.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Jul 2024
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, randomized, single masked study investigating the effects of twice per week for 6 weeks of Swedish massage therapy (SMT) vs. a light touch (LT) control on brain activity, assessments, and autonomic function in non-psychiatric control subjects.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Becky Kinkead, University of Utah
- Investigators
- Becky Kinkead, PhD, Principal investigator, Utah, University of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190326
- Sponsor's protocol ID
- IRB_00155218
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging and Correlates of Response
- ClinicalTrials.gov ID
- NCT07190326
- Acronym / sponsor ID
- IRB_00155218
- Conditions
- Healthy Control
- Keywords
- massage, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Sep 2025 (actual)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, randomized, single masked study investigating the effects of twice per week for 6 weeks of Swedish massage therapy (SMT) vs. a light touch (LT) control on brain activity, assessments, and autonomic function in non-psychiatric control subjects.
| Arm | Type | Receives |
|---|---|---|
| Swedish Massage Therapy | Experimental | Other: Swedish Massage TherapyThe 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. |
| Light Touch Control | Active comparator | Other: Light Touch ControlThe 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Swedish Massage TherapyThe 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 |
| Light Touch ControlThe 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 |
Primary outcome
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.
2 secondary outcomes
Change in neuronal connectivity in response to fearful/angry faces task
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Becky Kinkead, PhD principal investigator
Utah, University of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swedish Massage Therapy in people with Healthy Control, run by University of Utah 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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Becky Kinkead, PhD (801-587-8626, becky.kinkead@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in rsFC (time frame: 6-weeks). 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 27 Aug 2026.