Clinical trial NCT06506253: Massage for GAD: Neuroimaging and Clinical Correlates of Response
Official title: Massage for GAD: Neuroimaging and Clinical Correlates of Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: fMRI
massage
touch
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-07-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 GAD.
Primary purpose: TREATMENT

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.

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.

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 (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')

Primary outcomes:
measure: Pre-to-post-treatment change in resting state functional connectivity
timeFrame: 6 weeks
Secondary outcomes:
measure: Pre-to-post-treatment change in response to fearful/angry faces task and clinical response on the HAM-A.
timeFrame: 6 weeks
measure: Autonomic activity (heart rate variability, heart rate, pulse).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Mental Health Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Mark Rapaport
role: PRINCIPAL_INVESTIGATOR
References: