Status:
ACTIVE_NOT_RECRUITING
Massage: Neuroimaging and Correlates of Response - 6-week Study
Lead Sponsor:
University of Utah
Conditions:
Healthy Control
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief 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 ...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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')
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT07190326
Start Date
July 1 2024
End Date
June 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Huntsman Mental Health Institute
Salt Lake City, Utah, United States, 84108