Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation
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|ClinicalTrials.gov Identifier: NCT02935465|
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : October 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic, Non-neuropathic Back Pain||Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) Behavioral: Support Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation in Opioid-Treated Chronic Pain Patients|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Mindfulness-Oriented Recovery Enhancement
Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.
Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)
Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.
Active Comparator: Support Group
Participants will attend a support group weekly for eight weeks.
Behavioral: Support Group
A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
- Changes in endogenous opioid system function in response to pain challenge [ Time Frame: Change from week 0 to 8 weeks ]PET opioid receptor binding potential from baseline through pain challenge
- Changes in fMRI activity level during natural reward processing [ Time Frame: Change from week 0 to 8 weeks ]Blood oxygen dependent signal (BOLD) response during viewing and regulating response to natural reward cues measured during a fMRI scan.
- Pain sensitivity as a measure of volume of hypertonic saline [ Time Frame: Change from week 0 to 8 weeks ]Volume of hypertonic saline to maintain pain at 40 out of 100 on a VAS
- Self-report affect ratings [ Time Frame: Change from week 0 to 8 weeks ]
- Significant correlation between PET and fMRI measures with improvements in clinical pain, affect, and opioid use [ Time Frame: Change from week 0 to 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935465
|Contact: Eric L Garland, PhDemail@example.com|
|Contact: Sarah Priddy, MSSWfirstname.lastname@example.org|
|United States, Utah|
|College of Social Work||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Karen Wheeler 801-581-8028 email@example.com|
|Principal Investigator:||Eric L Garland, PhD||The University of Utah|