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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Chronic Musculoskeletal Disease
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Acceptance and Committment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted6 Aug 2020
- Study start31 Aug 2018
- Primary completion30 Apr 2019
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Principal investigator, Semra Aytur, University of New Hampshire
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 18824301Hemington 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 26669874Napadow 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 20506181Sporns 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 30250388van 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 31213886Zalesky 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 20600983Bond 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of Acceptance and Commitment Therapy for Chronic Pain: A Network-Based fMRI Approach
- ClinicalTrials.gov ID
- NCT04502992
- Acronym / sponsor ID
- UNH-06-6991-01
- Conditions
- Chronic Musculoskeletal Disease
- Keywords
- Acceptance and commitment therapy, chronic pain, brain networks, functional connectivity, graph theory, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm (pre-post, quasi-experimental) | Other | Behavioral: Acceptance and Committment TherapyPre-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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Committment TherapyAcceptance 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. | Behavioural | Single Arm (pre-post, quasi-experimental) |
Primary outcome
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
Derived from fMRI data, the NBS the Network Based Statistic (NBS) is used to examine changes in functional connectivity from pre-to post ACT.
2 secondary outcomes
Change in self-reported measures of depression from pre-to post-ACT
Time frame: 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
Time frame: Measured by comparison of pre-treatment (baseline) and 4-week post-treatment (within 1 week after treatment completion) assessment data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Background: PubMed 18824301Vowles 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.
- Background: PubMed 26669874Hemington 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.
- Background: PubMed 20506181Napadow 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.
- Background: PubMed 30250388Sporns 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.
- Background: PubMed 31213886van 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.
- Background: PubMed 20600983Zalesky 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.
- Background: PubMed 22035996Bond 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.