The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress

• Register: ClinicalTrials.gov
• Last refreshed on: 12 October 2015
• Main ID: NCT01301105
• Date of registration: 18/02/2011
• Prospective Registration: No
• Primary sponsor: University of Wisconsin, Madison
• Public title: The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress
• Scientific title: The Effects of Mindfulness Training on Pain Regulation, Negative Affect, Attention, and Social Stress.
• Date of first enrolment: October 2005
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01301105
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Richard Davidson, Ph.D.
• Affiliation: UW-Madison

• Name: Antoine Lutz, Ph.D.
• Affiliation: UW-Madison

Key inclusion & exclusion criteria

Inclusion Criteria:

1.1 Risk Factors

- Able to lie still in the scanner for 90 minutes

- Weighs under 300 pounds

1.2 Factors impacting on the outcome measures

- 18-65 years old

- Right-handed

- No previous experience with meditation.

- No daily practice with other mind-body techniques (e.g., yoga, tai-chi, but previous
exposure to yoga is okay)

- In good general health as determined by the investigator

1.3 Logistic Issues

- Able to walk

- Able to understand and speak English

- Able to provide written consent prior to admission

- Able to see without glasses (as if looking through binoculars)

Exclusion Criteria:

2.1 Risk Factors

- Any metallic implants, such as prostheses that cannot be removed, aneurysm clip-S,
dental or orthodontic (filings are okay), or orthopedic (e.g., pins, rods, screws,
nails) [okay with doctors note]

- Any electronic implants, such as cardiac pacemakers, cardiac defibrillator,
artificial heart valve, cardiac pace wires,

- Lens implants prior to 1983

- Breast/penile, electrodes, neurostimulators/biostimulators, pumps (e.g. drug infusion
device), bone or socket implants (Check with PI or MR technician)

- Any type of prosthesis

- Any permanent cosmetics (e.g., eyeliner) prior to 1975

- Any tattoos on upper body prior to 1975

- Any irremovable non plastic body piercing(s)

- Has ever worked as an occupational metal grinder without protective glasses

- Has ever worked with metal as a hobby without protective glasses

- Has ever had or sought medical attention for metal in the eyes [requires orbit x-ray]

- Has ever has metal fragments removed from eyes [requires orbit x-ray]

- Has ever been struck by a gun shot, B.B. or shrapnel, and the bullet stuck
[judgement]

- Has a history of any metal in body

- Diabetes

- Peripheral vascular disease, peripheral arterial disease, Raynaud's disease, or any
other diagnosed circulatory disorders

- Body mass index (BMI) below 18.5

- Any involuntary motor disorders

- Has a cochlear implant

- Wears a hearing aid that cannot be taken out (Check with PI or MR technician)

- Wears a hearing aid

- Wears dentures that cannot be removed or contain metal

- A subject who is claustrophobic

- A female subject who is pregnant or has an intrauterine device (IUD)

- Allergic to adhesive tape

- A history of problems of any kind during blood draws

- Women who may be pregnant

- Women who have an intrauterine device (IUD) [okay with a doctors note]

- 2 or more of the following [judgment]

- Diagnosed hypertension?

- Hyperlipidemia

- High cholesterol

- Obesity can be calculated from weight & height info.

- Smoke cigarettes

- Family history of coronary or atherosclerotic disease (parents/siblings prior to age
55)

2.2 Factors impacting on the outcome measures

- Current medical disorders that might make interpretation of scan data difficult

- Has a problem with alcohol or non prescription drugs

- Use of medications that affects CNS function, including psychotropics, opiate
medication or corticosteroids, during the last 3 months

- Any prescribed psychotropic medications, currently or during the last 3 months (These
include medications for anxiety, depression, or other psychological problems)

- Plans to start taking any prescribed psychotropic medications

- Takes inhaled steroids for asthma? (e.g., Fluticasone)

- Takes any corticosteroids?

- Night shift workers (11 pm to 7 am) d/t potential disruption of cortisol level
variability

- Diabetes requiring insulin treatment

- Has TMJ (Temporal Mandibular Joint) disorder or other problems with biting/chewing

- Previous training in meditation

- Currently meditates on a regular basis

- Daily yoga, tai-chi, or Qigong practice

- Engagement in moderate sport and recreational activities more than 5 times a week

- Engagement in vigorous sport and recreational activities more than 4 times a week

2.3 Logistic Issues

- Phobia of needles

- Not able to attend an informational session, all class meetings, and all clinic
visits



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Immune Mechanisms

Brain Mechanisms

Focus on Pain Regulation Mechanisms

Basic Affective Mechanisms

Attention Mechanisms

Endocrine Mechanisms

Social Stress Mechanisms

Intervention(s)

Behavioral: Health Enhancement Program (HEP)

Behavioral: Mindfulness Based Stress Reduction (MBSR)

Secondary ID(s)

AT002114-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors