Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will help find out if massage and touch therapies change brain activity and reduce the symptoms of anxiety. Massage therapy has well known health benefits. This study will help to learn if these therapies reduce the symptoms of anxiety by changing brain activity. Participation in the study will last about 8 weeks. This is a randomized research study. "Randomized" means that participants will be assigned to a study group by chance, like flipping a coin. Participants will be randomized into one of two study groups, and will have an equal chance of being placed in one of the groups: - Swedish massage therapy twice per week for 6 weeks - Light touch therapy twice per week for 6 weeks At each study, the study staff ask about life stressors, medical health, medicine use, and illicit substance use over the past week. The study uses magnetic resonance imaging (MRI) as well as functional MRI (fMRI) to look at the structure and activation of the brain. Participants will undergo two brain scanning sessions, one before the first intervention and one immediately after the last Swedish massage or light touch therapy. The scans will last approximately 45 minutes. During the brain scanning sessions, information on heart rate, blood pressure, temperature and breathing will also be collected.
This is a two-arm, randomized, single masked study investigating the effects of twice per week for 6 weeks Swedish massage therapy (SMT) vs. a light touch (LT) control on brain activity, assessments, and autonomic function in non-psychiatric control subjects. The Primary Objective is to identify brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the neutral/fearful/angry faces task in normal control subjects. The secondary objective is to correlate changes in autonomic measures with resting state fMRI.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Swedish Massage Therapy | Experimental | 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 two sessions per week for 6-weeks. |
|
| Light Touch Control | Active Comparator | 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 two sessions per week for 6-weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swedish Massage Therapy | Other | 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 two sessions per week for 6-weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| change in rsFC | Change in resting state functional activity in brain networks activated by SMT vs. LT using resting state fMRI in healthy non-psychiatric control subjects will be calculated at week 6, after the last intervention relative to baseline. | 6-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neuronal connectivity in response to fearful/angry faces task | pre-to-post-intervention change in neuronal connectivity in response to fearful/angry faces task during fMRI. | 6-weeks |
| Correlation of changes in autonomic measures (heart rate variability, heart rate, pulse) with resting state neuronal functional connectivity in response to fearful/angry faces task during fMRI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Rapaport, MD | Utah, University of | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Mental Health Institute | Salt Lake City | Utah | 84108 | United States |
We will maximize the appropriate sharing of scientific data generated from the conducted research, consistent with privacy, security, informed consent, and proprietary issues. Data management and sharing will be addressed in the informed consent process, including communicating with prospective participants how their scientific data are expected to be used and shared.
Following peer-reviewed publication of our results, de-identified materials and data generated in the course of this project will made available upon reasonable request.
Scientific data will be made accessible in a timely manner for use by the research community and the broader public. Specifically, scientific data will be made accessible as soon as possible, and no later than the time of an associated publication. We will consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, journal policies) as guidance for the minimum time frame scientific data should be made available. However, we will make scientific data available for as long as it is useful for the larger research community, institutions, and/or the broader public.
Not provided
Not provided
This is a two-arm, randomized, single masked study investigating the effects of twice per week for 6 weeks of Swedish massage therapy (SMT) vs. a light touch (LT) control on brain activity, assessments, and autonomic function in non-psychiatric control subjects.
Not provided
Not provided
Of necessity, the coordinator, subjects, and therapists will know their randomized group assignment. Other study staff interacting with participants, including the investigator completing adverse event assessments, will be masked to the treatment assignment. Participants randomized to a treatment arm will be asked not to disclose their assigned treatment to those staff members. The study coordinator and therapists performing the SMT and LT interventions will not discuss subjects' treatment assignment with other staff at any time during the study. The study statistician will perform and report the primary and secondary outcome analyses using masked treatment codes. The non-masked coordinator will have access to the study randomization schedule and may unmask subjects only in the case of emergency, or if necessary, to establish proper follow-up treatment for a condition that arises during the course of the study.
|
| Light Touch Control | Other | 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 two sessions per week for 6-weeks. |
|
Change in autonomic activity (heart rate variability, heart rate, pulse) will be correlated with changes in resting state functional connectivity in response to the fearful/angry faces task during fMRI. |
| Week 6 |