Generalized Anxiety DisorderNCT06506253
Massage for GAD: Neuroimaging and Clinical Correlates of Response
A study testing Swedish Massage Therapy and Light Touch Therapy in people with Generalized Anxiety Disorder, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Swedish Massage Therapy and Light Touch Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects aged ≥ 18 and < 65 years old.
- Medically stable.
- Primary Diagnosis of GAD.
- Hamilton Rating Scale for Anxiety (HAM-A) ≥15
- 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.
- Ability to lie prone or supine for one hour at a time, given the nature of the massage intervention
Show all 9Show fewer
- Subjects must have a permanent domicile
- Subjects must be able to comply with the research protocol
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- 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
- Pregnancy (per participant report, pregnancy testing not done for study)
- Usually is asleep during the daytime (ie. due to working third-shift), or any other behaviors that routinely disrupt normal diurnal (daily) rhythms
- Current (past month) rigorous dieting (defined as <1200 calories per day for ≥2 consecutive days)
- 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)
- ingestion of 5 drinks or more in a 2 hour period
Show all 17Show fewer
- ingestion of 7 drinks or more in a 24 hour period
- Initiation of psychotherapy or CAM interventions because of psychological distress within 90 days before screening visit.
- Has a lifetime diagnosis of PTSD, bipolar disorder, OCD, psychotic disorders, OR a current diagnosis of an alcohol or substance use disorder
- Meets criteria for current suicidal or homicidal ideation
- 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
- Subjects currently employing any other CAM manual therapy and/or holistic therapies to treat a perceived health problem
- 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.
- History of cancer that required chemotherapy and/or radiation treatment.
- 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.
- 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.
- Current participation in another research study (excluding large natural cohort trials such as 'All of Us')
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Mental Health Institute
Salt Lake City, Utah, 84108
About this study
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:
Read more
- Swedish massage therapy twice per week for 6 weeks.
- 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.
Read the 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
- Being tested
- Swedish Massage Therapy, Light Touch Therapy
- Keywords
- fMRI, massage, touch
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish Massage TherapyOther
Touch therapy
Light Touch TherapyOther
Touch therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 2/week for a total of 6 weeks. Receives: Other: Swedish Massage Therapy |
| 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 2/week for a total of 6 weeks. Receives: Other: Light Touch Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-to-post-treatment change in resting state functional connectivity
Identification of brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the fearful faces task in subjects with GAD.
Measured: 6 weeks
Secondary outcomes (2)
Pre-to-post-treatment change in response to fearful/angry faces task and clinical response on the HAM-A.
Correlation of pre-to-post-treatment change in rsFC with changes in anxiety scores (HAM-A) within both treatment groups.
Measured: 6 weeks
Autonomic activity (heart rate variability, heart rate, pulse).
Correlation of changes in autonomic measures with clinical response and rsFC.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 May 2024
- Primary completion28 Apr 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Becky Kinkead, University of Utah
- Investigators
- Becky Kinkead, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506253
- Sponsor's protocol ID
- IRB00153327
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will maximize the appropriate sharing of scientific data generated from NIH-funded or 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. A certificate of confidentiality will be in place.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massage for GAD: Neuroimaging and Clinical Correlates of Response
- ClinicalTrials.gov ID
- NCT06506253
- Acronym / sponsor ID
- IRB00153327
- Conditions
- Generalized Anxiety Disorder
- Keywords
- fMRI, massage, touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Swedish massage therapy twice per week for 6 weeks.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Swedish Massage Therapy | Experimental | Other: Swedish Massage TherapyThe 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 2/week for a total of 6 weeks. |
| Light Touch Control | Active comparator | Other: Light Touch TherapyThe 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 2/week for a total of 6 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female subjects aged ≥ 18 and < 65 years old.
- Medically stable.
- Primary Diagnosis of GAD.
- Hamilton Rating Scale for Anxiety (HAM-A) ≥15
- 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.
Key exclusion criteria (17 listed)
- 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
- Pregnancy (per participant report, pregnancy testing not done for study)
- Usually is asleep during the daytime (ie. due to working third-shift), or any other behaviors that routinely disrupt normal diurnal (daily) rhythms
- Current (past month) rigorous dieting (defined as <1200 calories per day for ≥2 consecutive days)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swedish Massage TherapyTouch therapy | Other | Swedish Massage Therapy |
| Light Touch TherapyTouch therapy | Other | Light Touch Control |
Primary outcome
Pre-to-post-treatment change in resting state functional connectivity
Time frame: 6 weeks
Identification of brain networks activated by SMT vs. LT using resting state fMRI and Functional Connectivity during the fearful faces task in subjects with GAD.
2 secondary outcomes
Pre-to-post-treatment change in response to fearful/angry faces task and clinical response on the HAM-A.
Time frame: 6 weeks
Autonomic activity (heart rate variability, heart rate, pulse).
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. We will maximize the appropriate sharing of scientific data generated from NIH-funded or 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. A certificate of confidentiality will be in place.
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Becky Kinkead principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swedish Massage Therapy and Light Touch Therapy in people with Generalized Anxiety Disorder, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-to-post-treatment change in resting state functional connectivity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.