Massage for GAD: Neuroimaging and Clinical Correlates of Response

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06506253
Status
Recruiting
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Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Swedish Massage Therapy — OTHER
    Touch therapy
  • Light Touch Therapy — OTHER
    Touch therapy

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Swedish Massage Therapy
    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 2/week for a total of 6 weeks.
  • Active Comparator: Light Touch Control
    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 2/week for a total of 6 weeks.

Primary Outcome Measure

Pre-to-post-treatment change in resting state functional connectivity [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Mental Health InstituteSalt Lake CityUtah84108
Mark Rapaport, MD
[email protected]
801-587-8626
Becky Kinkead, PhD
[email protected]
801-587-0689
Mark Rapaport, MD (PRINCIPAL_INVESTIGATOR)
Brent Kious, MD, PhD (SUB_INVESTIGATOR)
Perry Renshaw, MD, PhD (SUB_INVESTIGATOR)
Eric Garland, PhD (SUB_INVESTIGATOR)
Young-Hoon Sung, MD (SUB_INVESTIGATOR)

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By research site
Huntsman Mental Health Institute· Salt Lake City, UT

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