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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935465
|Contact: Eric L Garland, PhDfirstname.lastname@example.org|
|Contact: Sarah Priddy, MSSWemail@example.com|
|United States, Utah|
|College of Social Work||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Karen Wheeler 801-581-8028 firstname.lastname@example.org|
|Principal Investigator:||Eric L Garland, PhD||The University of Utah|