RECRUITING

Massage for GAD: Neuroimaging and Clinical Correlates of Response

Conditions

Generalized Anxiety Disorder fMRI massage touch

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Massage for GAD: Neuroimaging and Clinical Correlates of Response

Quick Facts

Study Start:2024-05-01

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06506253

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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 (per participant report, pregnancy testing not done for study) 3. Usually is asleep during the daytime (ie. due to working third-shift), or any other behaviors that routinely disrupt normal diurnal (daily) rhythms 4. Current (past month) rigorous dieting (defined as \<1200 calories per day for ≥2 consecutive days) 5. In the month before screening visit, excessive regular use of alcohol, as defined by either of the following, twice a month or more often: (a drink is one 5 ounce glass of wine or equivalent) 1. ingestion of 5 drinks or more in a 2 hour period 2. ingestion of 7 drinks or more in a 24 hour period 6. Initiation of psychotherapy or CAM interventions because of psychological distress within 90 days before screening visit. 7. Has a lifetime diagnosis of PTSD, bipolar disorder, OCD, psychotic disorders, OR a current diagnosis of an alcohol or substance use disorder 8. Meets criteria for current suicidal or homicidal ideation 9. Subjects who have massages on a regular basis. Regular massage usage will be defined as receiving on average 4 or more massages/year for the last 5 years 10. Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem 11. History of head injury or neurological disorder, that in the investigator's opinion would impact the data or preclude safe and successful completion of the study. 12. History of cancer that required chemotherapy and/or radiation treatment. 13. General contraindication to MRI - Because MRI uses a very strong magnet, subjects cannot have metals in their bodies or certain medical conditions. Subjects cannot have a cardiac pacemaker; hearing aid; any other implant metal in their body or eyes, including pins, screws, shrapnel, plates, teeth braces, or dentures. Subjects cannot have tattoos on their head, such as eyeliner or other permanent makeup, as they may make it impossible to get clear and usable images. 14. Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol, or complete the study. 15. Current participation in another research study (excluding large natural cohort trials such as 'All of Us')

Inclusion Criteria

Exclusion 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.

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 (per participant report, pregnancy testing not done for study)
3. Usually is asleep during the daytime (ie. due to working third-shift), or any other behaviors that routinely disrupt normal diurnal (daily) rhythms
4. Current (past month) rigorous dieting (defined as \<1200 calories per day for ≥2 consecutive days)
5. In the month before screening visit, excessive regular use of alcohol, as defined by either of the following, twice a month or more often: (a drink is one 5 ounce glass of wine or equivalent)
1. ingestion of 5 drinks or more in a 2 hour period
2. ingestion of 7 drinks or more in a 24 hour period
6. Initiation of psychotherapy or CAM interventions because of psychological distress within 90 days before screening visit.
7. Has a lifetime diagnosis of PTSD, bipolar disorder, OCD, psychotic disorders, OR a current diagnosis of an alcohol or substance use disorder
8. Meets criteria for current suicidal or homicidal ideation
9. Subjects who have massages on a regular basis. Regular massage usage will be defined as receiving on average 4 or more massages/year for the last 5 years
10. Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem
11. History of head injury or neurological disorder, that in the investigator's opinion would impact the data or preclude safe and successful completion of the study.
12. History of cancer that required chemotherapy and/or radiation treatment.
13. General contraindication to MRI - Because MRI uses a very strong magnet, subjects cannot have metals in their bodies or certain medical conditions. Subjects cannot have a cardiac pacemaker; hearing aid; any other implant metal in their body or eyes, including pins, screws, shrapnel, plates, teeth braces, or dentures. Subjects cannot have tattoos on their head, such as eyeliner or other permanent makeup, as they may make it impossible to get clear and usable images.
14. Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol, or complete the study.
15. Current participation in another research study (excluding large natural cohort trials such as 'All of Us')

Contacts and Locations

Study Contact

Mark Rapaport, MD

CONTACT

801-587-8626

mark.rapaport@hsc.utah.edu

Becky Kinkead, PhD

CONTACT

801-587-0689

becky.kinkead@hsc.utah.edu

Principal Investigator

Mark Rapaport

PRINCIPAL_INVESTIGATOR

University of Utah

Study Locations (Sites)

Huntsman Mental Health Institute

Salt Lake City, Utah, 84108

United States

Collaborators and Investigators

Sponsor: University of Utah

Mark Rapaport, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01

Study Completion Date2025-08

Study Record Updates

Study Start Date2024-05-01

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

fMRI
massage
touch

Additional Relevant MeSH Terms

Generalized Anxiety Disorder