Effects of massage on anxiety and brain activity

Massage for GAD: Neuroimaging and Clinical Correlates of Response

This study is testing whether Swedish massage can help reduce anxiety and improve brain activity in people with Generalized Anxiety Disorder compared to light touch therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: University of Utah (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT06506253 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of Swedish massage therapy compared to light touch therapy on brain activity and symptoms in individuals with Generalized Anxiety Disorder (GAD). Participants will be randomly assigned to receive either therapy twice a week for six weeks, with brain activity monitored through fMRI scans before and after the intervention. The study aims to identify brain networks activated by these touch interventions and correlate changes in brain activity with clinical anxiety scores and autonomic function. Additionally, the trial will explore the effects of massage on stress, depression, and overall functioning.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a primary diagnosis of Generalized Anxiety Disorder and a Hamilton Rating Scale for Anxiety score of 15 or higher.

Not a fit: Patients currently using nicotine or illicit drugs, or those with recent medication changes that could affect study outcomes, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-pharmacological treatment option for patients with Generalized Anxiety Disorder.

How similar studies have performed: While the specific combination of massage and neuroimaging in this context may be novel, previous studies have shown positive effects of massage therapy on anxiety symptoms.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects aged ≥ 18 and \< 65 years old.
2. Medically stable.
3. Primary Diagnosis of GAD.
4. Hamilton Rating Scale for Anxiety (HAM-A) ≥15
5. 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.
6. Ability to lie prone or supine for one hour at a time, given the nature of the massage intervention
7. Subjects must have a permanent domicile
8. Subjects must be able to comply with the research protocol
9. Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

1. 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
2. Pregnancy (per participant report, pregnancy testing not done for study)
3. Usually is asleep during the daytime (ie. due to working third-shift), or any other behaviors that routinely disrupt normal diurnal (daily) rhythms
4. Current (past month) rigorous dieting (defined as \<1200 calories per day for ≥2 consecutive days)
5. 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)

   1. ingestion of 5 drinks or more in a 2 hour period
   2. ingestion of 7 drinks or more in a 24 hour period
6. Initiation of psychotherapy or CAM interventions because of psychological distress within 90 days before screening visit.
7. Has a lifetime diagnosis of PTSD, bipolar disorder, OCD, psychotic disorders, OR a current diagnosis of an alcohol or substance use disorder
8. Meets criteria for current suicidal or homicidal ideation
9. 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
10. Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem
11. 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.
12. History of cancer that required chemotherapy and/or radiation treatment.
13. 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.
14. 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.
15. Current participation in another research study (excluding large natural cohort trials such as 'All of Us')

Where this trial is running

Salt Lake City, Utah

• Huntsman Mental Health Institute — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Mark Rapaport — University of Utah
• Study coordinator: Mark Rapaport, MD

Conditions Generalized Anxiety Disorder; fMRI; massage; touch