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Chronic Musculoskeletal DiseaseNCT04502992

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

A study testing Acceptance and Committment Therapy in people with Chronic Musculoskeletal Disease, run by University of New Hampshire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Musculoskeletal Disease
What is being tested?
Acceptance and Committment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
31 Aug 2018to 15 Jun 2020
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Communication Science and Disorders Research Laboratory, University of New Hampshier

    Durham, New Hampshire, 03824

Other trials in United States

About this study

Official title: Neural Mechanisms of Acceptance and Commitment Therapy for Chronic Pain: A Network-Based fMRI Approach

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.

Read the detailed description

Over 100 million Americans suffer from chronic pain (CP), which causes more disability than any other medical condition in the U.S. at a cost of $560-$635 billion per year. Opioid analgesics are frequently used to treat CP. However, long term use of opioids can cause brain changes such as opioid-induced hyperalgesia that, over time, increase pain sensation. Also, opioids fail to treat complex psychological factors that worsen pain-related disability, including beliefs and emotional responses to pain. Cognitive behavioral therapy (CBT) can be efficacious for CP. However, CBT does not focus on important factors needed for long-term functional improvement, including attainment of personal goals and the psychological flexibility to choose responses to pain.

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. ACT was developed in 1986 by Stephen C. Hayes who began to examine how language and thought influence internal experiences. By emphasizing acceptance instead of avoidance, ACT differs from many other forms of cognitive behavioral therapy. Although not originally designed for CP, ACT has been shown to be efficacious in terms of clinical outcomes, adherence to treatment, and retention, earning the status of a "well-established" treatment for CP from the American Psychological Association. ACT aims to increase psychological flexibility, and has been associated with improved health outcomes in many 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 situational demands; shift mindsets or behavioral repertoires when these strategies compromise personal or social functioning; maintain balance among important life domains; and be aware, open, and committed to behaviors that are congruent with deeply held values." ACT is a "third wave" behavioral treatment that has been shown to be efficacious for treating CP, as well as co-morbid conditions and factors (e.g., goal selection) related to long-term functional improvement. Additionally, patients who participate in ACT report greater long-term satisfaction compared to CBT. ACT is transdiagnostic and associated with improvements in physical functioning and pain-related disability, as well as decreases in emotional distress regardless of perceived pain intensity.

Resting-state functional magnetic resonance imaging (rsfMRI) allows for data to be collected while individuals with CP rest in the MRI scanner for a short period of time (<10 minutes). Thus, data provides information about the natural state of brain function in CP without having to apply any external sensory or cognitive stimulation. Analysis methods of rsfMRI have focused on multiple regions in the brain, targeting inherent and altered measures of connectivity between brain regions and within brain networks. Further, alterations in brain structure and function have been demonstrated in multiple CP syndromes. Prior imaging research has suggested that CP results in abnormal hyper-connectivity of brain networks associated with self-reflection (default mode, DMN), emotion (salience, SN), and cognitive control (frontal parietal, FPN) networks. While ACT has been successful in helping those with CP create a more functional and personally meaningful life, a critical gap in the understanding of the neural mechanisms underlying ACT remains.

Only two prior investigations have used fMRI to assess neural mechanisms of ACT-based interventions for CP. The first investigated task fMRI activation using pressure evoked pain. Participants with fibromyalgia showed increased activation in the ventrolateral prefrontal cortex (vlPFC) and orbitofrontal cortex (OFC) post-ACT after 12 weeks of ACT. Additionally, results showed pain-evoked changes in connectivity between the vlPFC and thalamus after ACT. Researchers in the second investigation conducted an 8-week ACT intervention vs. health education control (HEC) for participants with comorbid CP and opioid addiction. Focusing on DMN and pain regions in the brain, participants receiving ACT exhibited decreased activation during evoked pain in the middle frontal gyrus (MFG), inferior parietal lobule (IPL), insula, anterior cingulate cortex (aCC), posterior cingulate cortex (pCC), and superior temporal gyrus (STG) compared with HEC participants.

In the present study, ACT was delivered to nine women with CP. fMRI was used to identify changes in brain networks underlying ACT-related behavioral outcomes in CP. Based on prior work examining ACT in CP, the investigators hypothesize that: (1) ACT will reduce connectivity strength within and between the DMN, SN, and FPN, and that (2) changes in connectivity strength will correlate with changes in behavioral outcomes from pre- to post-ACT.

Being tested
Acceptance and Committment Therapy
Keywords
Acceptance and commitment therapy, chronic pain, brain networks, functional connectivity, graph theory, fMRI
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Committment TherapyBehavioural

    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.

Study groups in NCT04502992
Study groupRoleWhat they receive
Single Arm (pre-post, quasi-experimental)OtherPre-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).
Receives: Behavioral: Acceptance and Committment Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)
  1. Change in self-reported measures of depression from pre-to post-ACT

    Depression Scale, as measured by the Center for Epidemiologic Studies Scale (CES-D)

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

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

    NIH Toolbox Neuro-QoLTM (Quality of Life in Neurological Disorders) scale

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start31 Aug 2018
  3. Primary completion30 Apr 2019
  4. Study completion15 Jun 2020

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04502992
Sponsor's protocol ID
UNH-06-6991-01
Status last verified
Aug 2020
First submitted
23 Jul 2020
Last updated
6 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18824301
  • 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.

    PubMed 26669874
  • 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.

    PubMed 20506181
  • 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.

    PubMed 30250388
  • 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.

    PubMed 31213886
  • 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.

    PubMed 20600983
  • 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.

    PubMed 22035996

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Committment Therapy in people with Chronic Musculoskeletal Disease, run by University of New Hampshire 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 8 inclusion and 5 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 6 Aug 2020. 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?

Change in Network Based Statistic (NBS) from pre-to post-ACT (time frame: Measured by comparison of pre-treatment (baseline) and 4-weeks post-treatment (within 1 week after treatment completion) fMRI scan data). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502992, which also lists 7 linked publications.

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 6 Aug 2020.

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