NCT06506253 · University of Utah
Massage for GAD: Neuroimaging and Clinical Correlates of Response
What this study is about
This clinical trial will compare the effects of Swedish massage or light touch therapy on brain activity and symptoms of anxiety. This is a randomly assigned research study and subjects will be randomly assigned into one of two study touch intervention groups, and will have an equal chance of being placed in one of the groups: 1. Swedish massage therapy twice per week for 6 weeks. 2.
View original scientific description
This clinical trial will compare the effects of Swedish massage or light touch therapy on brain activity and symptoms of anxiety. This is a randomized research study and subjects will be randomized into one of two study touch intervention groups, and will have an equal chance of being placed in one of the groups: 1. Swedish massage therapy twice per week for 6 weeks. 2. Light touch therapy twice per week for 6 weeks. The Primary Objective is to identify brain networks activated by touch interventions using fMRI brain imaging in subjects with generalized anxiety disorder. Subjects will undergo two fMRI scanning sessions (one before and one after) twice per week for 6 weeks of touch intervention. Subjects will also be asked to complete questionnaires on anxiety, stress and depression.
Interventions
OTHER
Swedish Massage Therapy
Touch therapy
OTHER
Light Touch Therapy
Touch therapy
Primary outcome measures
Pre-to-post-treatment change in resting state functional connectivity
Time frame: 6 weeks
Identification of brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the fearful faces task in subjects with GAD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female subjects aged ≥ 18 and \< 65 years old.
- Medically stable.
- Primary Diagnosis of GAD.
- Hamilton Rating Scale for Anxiety (HAM-A) ≥15
- Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks (prior to initiation of randomized treatment) and willing to maintain a stable dose.
- 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, regular 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)
- ingestion of 5 drinks or more in a 2 hour period
- ingestion of 7 drinks or more in a 24 hour period
- Initiation of psychotherapy or CAM interventions because of psychological distress within 90 days before screening visit.
- Has a lifetime diagnosis of PTSD, bipolar disorder, OCD, psychotic disorders, OR a current diagnosis of an alcohol or substance use disorder
- 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')
Where
- Salt Lake City, Utah
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations