Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT06506253

Massage for GAD: Neuroimaging and Clinical Correlates of Response

Led by University of Utah · Updated on 2025-09-09

46

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial 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 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.

CONDITIONS

Official Title

Massage for GAD: Neuroimaging and Clinical Correlates of Response

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects aged 5 18 and < 65 years old
  • Medically stable
  • Primary Diagnosis of Generalized Anxiety Disorder (GAD)
  • Hamilton Rating Scale for Anxiety (HAM-A) score 5 15
  • Off concurrent psychotropic medication for at least 2 weeks prior to treatment or stable on current medication for at least 6 weeks and willing to maintain dose
  • Ability to lie prone or supine for one hour at a time
  • Permanent residence
  • Ability to comply with the research protocol
  • Able to provide informed consent and willing to sign consent form
Not Eligible

You will not qualify if you...

  • Current nicotine use within 3 months, illicit drug use, or medications that could alter study results
  • Pregnancy
  • Regular daytime sleeping or disrupted daily rhythms
  • Rigorous dieting (<1200 calories/day for 2+ consecutive days) in past month
  • Excessive alcohol use in past month (5+ drinks in 2 hours or 7+ drinks in 24 hours, twice a month or more)
  • Started psychotherapy or complementary/alternative medicine for psychological distress within 90 days
  • Lifetime diagnosis of PTSD, bipolar disorder, OCD, psychotic disorders, or current alcohol/substance use disorder
  • Current suicidal or homicidal ideation
  • Regular massage use (4+ massages/year for last 5 years)
  • Currently using other complementary manual or holistic therapies
  • History of head injury or neurological disorder affecting study
  • History of cancer treated with chemotherapy or radiation
  • Contraindications to MRI including metal implants, pacemakers, hearing aids, or head tattoos
  • Medical, psychiatric, cognitive, or other conditions preventing informed consent or protocol compliance
  • Participation in another research study (excluding large natural cohort trials)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Huntsman Mental Health Institute

Salt Lake City, Utah, United States, 84108

Actively Recruiting

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Research Team

M

Mark Rapaport, MD

CONTACT

B

Becky Kinkead, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Massage for GAD: Neuroimaging and Clinical Correlates of Response | DecenTrialz