NCT06506253 Massage for GAD: Neuroimaging and Clinical Correlates of Response
| NCT ID | NCT06506253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Generalized Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-07 |
Trial Parameters
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Brief 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.
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 (
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