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

NCT04502992 | Completed

• 1 other identifier: UNH-06-6991-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Musculoskeletal Disease

Keywords

Acceptance and commitment therapy; chronic pain; brain networks; functional connectivity; graph theory; fMRI

Outcome Measures

Primary Outcomes (1)

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

  Derived from fMRI data, the NBS the Network Based Statistic (NBS) is used to examine changes in functional connectivity from pre-to post ACT.

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

Secondary Outcomes (2)

• Change in self-reported measures of depression from pre-to post-ACT

  Measured by comparison of pre-treatment (baseline) and 4-week post-treatment (within 1 week after treatment completion) assessment data

• Change in self-reported measures of satisfaction with social role from pre-to post-ACT

  Measured by comparison of pre-treatment (baseline) and 4-week post-treatment (within 1 week after treatment completion) assessment data

Other Outcomes (3)

• Change in self-reported measures of pain acceptance from pre-to post-ACT

  Measured by comparison of pre-treatment (baseline) and 4-week post-treatment (within 1 week after treatment completion) assessment data

• Change in self-reported measures of pain interference from pre-to post-ACT

  Measured by comparison of pre-treatment (baseline) and 4-week post-treatment (within 1 week after treatment completion) assessment data

• Change in self-reported measures of acceptance and action from pre-to post-ACT

  Measured by comparison of pre-treatment (baseline) and 4-week post-treatment (within 1 week after treatment completion) assessment data

Study Arms (1)

Single Arm (pre-post, quasi-experimental)

OTHER

Pre-post intervention, single arm. (Intervention was 4 weeks of Acceptance and Committment therapy, 2 times per week, 90 min per session, in a group setting).

Behavioral: Acceptance and Committment Therapy

Interventions

Acceptance and Committment Therapy BEHAVIORAL

Acceptance and Commitment Therapy (ACT) is a mindfulness-based therapy that focuses on enabling individuals to accept what is out of their control, and to commit to valued actions that enrich their lives (Vowles \& McCracken, 2008). By emphasizing acceptance instead of avoidance, ACT differs from many other forms of cognitive behavioral therapy. ACT has been shown to be efficacious in terms of clinical outcomes, adherence to treatment, and retention. ACT aims to increase psychological flexibility, and has been associated with improved health outcomes prior randomized controlled clinical trials, including three systematic reviews specific to CP. Psychological flexibility is defined as an individual's ability to recognize and adapt to various demands; shift mindsets or behavioral responses when these strategies compromise personal or social functioning; and maintain balance among important life domains.

Single Arm (pre-post, quasi-experimental)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Hampshire: lead
• University of Texas at Austin: collaborator

Study Sites (1)

Communication Science and Disorders Research Laboratory, University of New Hampshier

Durham, New Hampshire, 03824, United States

Location

Related Publications (7)

• Vowles KE, McCracken LM, McLeod C, Eccleston C. The Chronic Pain Acceptance Questionnaire: confirmatory factor analysis and identification of patient subgroups. Pain. 2008 Nov 30;140(2):284-291. doi: 10.1016/j.pain.2008.08.012. Epub 2008 Sep 27.

  PMID: 18824301 BACKGROUND

• Hemington KS, Wu Q, Kucyi A, Inman RD, Davis KD. Abnormal cross-network functional connectivity in chronic pain and its association with clinical symptoms. Brain Struct Funct. 2016 Nov;221(8):4203-4219. doi: 10.1007/s00429-015-1161-1. Epub 2015 Dec 15.

  PMID: 26669874 BACKGROUND

• Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497.

  PMID: 20506181 BACKGROUND

• Sporns O. Graph theory methods: applications in brain networks. Dialogues Clin Neurosci. 2018 Jun;20(2):111-121. doi: 10.31887/DCNS.2018.20.2/osporns.

  PMID: 30250388 BACKGROUND

• van Ettinger-Veenstra H, Lundberg P, Alfoldi P, Sodermark M, Graven-Nielsen T, Sjors A, Engstrom M, Gerdle B. Chronic widespread pain patients show disrupted cortical connectivity in default mode and salience networks, modulated by pain sensitivity. J Pain Res. 2019 May 29;12:1743-1755. doi: 10.2147/JPR.S189443. eCollection 2019.

  PMID: 31213886 BACKGROUND

• Zalesky A, Fornito A, Bullmore ET. Network-based statistic: identifying differences in brain networks. Neuroimage. 2010 Dec;53(4):1197-207. doi: 10.1016/j.neuroimage.2010.06.041. Epub 2010 Jun 25.

  PMID: 20600983 BACKGROUND

• Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

  PMID: 22035996 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pre-post (quasi-experimental) design assessing the neural mechanisms underlying and behavioral changes associated with a 4 week Acceptance and Committment Therapy (ACT) intervention among participants with chronic musculoskeletal pain.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 6, 2020
• Study Start: August 31, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 15, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)