CompletedNot Applicable

Acceptance and Commitment Therapy, a Mindfulness-Based Approach for Treatment of Chronic Musculoskeletal Pain

United States9 participantsStarted 2018-08-31

Plain-language summary

Acceptance and Commitment Therapy (ACT) has been recognized as an effective, non-pharmacologic treatment for a variety of CP conditions. However, little is known about the neurologic mechanisms underlying ACT. The investigators conducted an ACT intervention in women (n=9) with chronic musculoskeletal pain. Functional magnetic resonance imaging (fMRI) data were collected pre- and post-ACT, and changes in functional connectivity (FC) were measured using Network-Based Statistics (NBS). Behavioral outcomes were measured using validated assessments such as the Acceptance \& Action Questionnaire (AAQ-II), the Chronic Pain Acceptance Questionnaire (CPAQ), the Center for Epidemiologic Studies Depression Scale (CES-D), and the NIH Toolbox Neuro-QoLTM (Quality of Life in Neurological Disorders) scales. Results suggest that, following the four-week ACT intervention, participants exhibited reductions in brain activation within and between key networks including self-reflection (default mode, DMN), emotion (salience, SN), and cognitive control (frontal parietal, FPN). These changes in connectivity strength were correlated with changes in behavioral outcomes including decreased depression and pain interference, and increased participation in social roles. This study is one of the first to demonstrate that improved function across the DMN, SN, and FPN may drive the positive outcomes associated with ACT. This study contributes to the emerging evidence supporting the use of neurophysiological indices to characterize treatment effects of alternative and complementary mind-body therapies.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * greater than or equal to 18 years of age * Chronic musculoskeletal pain duration for greater than or equal to 3 months * Pain interference greater than or equal to 4 on Brief Pain Inventory (BPI; 0-10 scale) * No known contraindication to participate * Access to regular transportation * No plans to move or become pregnant in the next 3 months * MRI safe * Personal cell phone with the ability to receive text messages and access web-based material (e.g. short surveys) Exclusion Criteria: * Unstable medical condition, including a movement disorder, such as restless leg syndrome or Parkinson's disease, a neurological disorder such as Alzheimer's disease, history of stroke or brain lesion, a psychiatric disorder such as schizophrenia or bipolar disorder * Significant cognitive impairment * Pregnancy(a test must be conducted on each scan day) * A recent history of: cancer, malignancy, accident or trauma, palliative care, acupuncture, chiropractic care, cognitive-based psychotherapy, other form of alternative care to treat pain condition * Metal in the body of any sort - implants, pacemaker, pins, screws

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Network Based Statistic (NBS) from pre-to post-ACT

Timeframe: Measured by comparison of pre-treatment (baseline) and 4-weeks post-treatment (within 1 week after treatment completion) fMRI scan data

Trial details

NCT IDNCT04502992

SponsorUniversity of New Hampshire

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-30

View on ClinicalTrials.gov More Chronic Musculoskeletal Disease trials