NCT06506253

Massage for GAD: Neuroimaging and Clinical Correlates of Response

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a two-arm, randomized, single masked study investigating the effects of Swedish massage therapy (SMT) vs. a light touch (LT) control on brain activity, clinical response, and autonomic function in subjects with Generalized Anxiety Disorder (GAD). Primary Objective: To identify brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the fearful faces task in subjects with GAD. Primary endpoint: Pre-to-post-treatment change in resting state functional connectivity. Secondary Objectives: To correlate pre-to-post-treatment change in rsFC with changes in anxiety scores (HAM-A) within both treatment groups. Secondary Endpoints: Pre-to-post-treatment change in response to fearful/angry faces task and clinical response on the HAM-A. To correlate changes in autonomic measures with clinical response and rsFC. Secondary Endpoint: Autonomic activity (heart rate variability, heart rate, pulse). Exploratory Objectives: To evaluate whether SMT improves stress depression and global functioning more than LT. Exploratory Endpoints: Change in Perceived Stress (Perceived Stress Scale), depression (Quick Inventory of Depressive Symptomatology (QIDS-SR)), and global functioning (Clinical Global Impression-S/I) from baseline to post intervention at week 6.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
OTHER	Swedish Massage Therapy	Touch therapy
OTHER	Light Touch Therapy	Touch therapy

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2024-07-17
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States