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New treatment option for Generalized Anxiety Disorder
Official title Massage for GAD: Neuroimaging and Clinical Correlates of Response
ClinicalTrials.gov ID: NCT06506253
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- Male or female people 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 assigned by chance treatment, OR stable on current medication for...
You likely can't join if
- Current (within 3 months of screening visit) nicotine use, illicit drug use, regular or long-term medication use that, in the opinion of the...
- 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...
- ingestion of 5 drinks or more in a 2 hour period
See the full eligibility criteria
- Male or female people 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 assigned by chance treatment, OR stable on current medication for a minimum of 6 weeks (prior to initiation of assigned by chance...
- Ability to lie prone or supine for one hour at a time, given the nature of the massage intervention
- people must have a permanent domicile
- people 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.
- 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
- 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
- people 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
- people 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, people cannot have metals in their bodies or certain medical conditions. people cannot have a cardiac pacemaker; hearing aid; any other implant...
- 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')
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.