DOI: 10.3886/icpsr39154.v1
title: Strategies To Assist with Management of Pain (STAMP), Wisconsin, Massachusetts, Utah, 2017-2024
title: Version 1

description: Chronic low back pain is a leading cause of disability and reduced quality of life for nearly 100 million individuals in the United States. Approximately 5 to 10 percent of these individuals are prescribed opioids for treating their chronic low back pain. Limited data exists on the long-term efficacy of opioid treatment while much concern exists regarding the harm they can do to a person. Despite medication treatment patients still suffer from inadequate pain relief, impaired function, and quality of life.
This study sought to compare the long-term effectiveness of two types of alternative therapy approaches - mindfulness based therapy (MBT) and cognitive behavioral therapy (CBT) - for treating chronic low back pain especially those being treated by opioids.
description: The purpose of this study was to to rigorously assess and compare the effectiveness of mindfulness-based (MBT) versus cognitive behavioral (CBT) therapies among adults with opioid-treated chronic low back pain (CLBP), and elucidate factors that would predict who could benefit most from each treatment. The two primary treatment response assessments to measure patient centered outcomes were:

<strong>Aim 1: </strong>Pain severity decreases while bodily function increases
<strong>Aim 2: </strong>Quality of life increases while daily opioid use / dose decreases
description: Survey data (DS1) was primarily completed online by participants' direct entry into the secure REDCap database developed for this study, using a study-designated tablet or laptop during an in-person visit. Participants could also complete surveys at home after receiving a specific electronic email link. Data collection for DS2 and DS3 were done primarily in person or via the telephone.
Study participants were equally assigned to one of the two types of alternative therapies (Mindfulness Based Therapy (MBT) or Cognitive Based Therapy (CBT)). Each group was to receive eight weekly 2-hour group sessions plus home practice. Follow-up data collection occurred four times at 3-month intervals after the baseline interview. Inclusion requirements were:

English speaking
Aged 21 years or older
Diagnosed with chronic low back pain (defined as a pain in lumbosacral region or sciatica for 3 or more months)
Self report of daily pain score of GE 3 on a 0-10 scale
Treated with GE 15 mg/day of morphine-equivalent dose for GE 3 months
Moderate disability score on Oswestry Disability Index (GE 21)
description: <strong>DS1: Survey Data</strong>

770 cases and 868 variables
Contains time periods Baseline, M3, M6, M9, and M12
Questions for time periods M3 and M9 are identical
The following scales / sections are asked in all 5 time periods - BPI, ODI, SF-12, HADS, OCC, COMM, HCUP
The following scales / sections are only asked during the Baseline, M6, and M12 time periods - NIH, PD, PCS, CPAQ-R, MAAS, PTSD, LS, and FLS

<strong>DS2: Medication Data</strong>

770 cases and 842 variables
Contains time periods Baseline, M3, M6, M9, and M12
Entries for up to 8 medications with follow-up information for type, strength, quantity, and frequency
Entries for 14 days counting backwards 14 to 1 with the number of each of the 8 medications taken on that particular day

<strong>DS3: Intervention Adherence Data</strong>

770 cases and 187 variables
Contains time periods M3, M6, M9, and M12
Each time period contains 14 days counting backwards 14 to 1
Each day contains 3 variables - date, minutes spent doing in-home therapy practice, and a spot for personal comments
description: None
description: Presence of Common Scales: 
Brief Pain Inventory (BPI)
Oswestry Disability Index (ODI)
SF-12v2 Health Survey
Hospital Anxiety and Depression Scale (HADS)
Opioid Compliance Checklist (OCC)
Current Opioid Misuse Measure (COMM)
Pain Catastrophizing Scale (PCS)
Chronic Pain Acceptance Questionnaire - Revised (CPAQ-R)
Mindfulness Attention Awareness Scale (MAAS)
Primary Care PTSD Screener (PC-PTSD)
Short Opiate Withdrawal Scale (SOWS)
description: Participant recruitment occurred at primary care and specialty clinics from the three target states, along with efforts out in the local communities. Participants were not excluded based on anxiety, depression, or substance use as those were common characteristics of the target population. The goal was to screen approximately 1,250 individuals from each of the three states with an expectation that about 450 of those individuals would be eligible for the study. From that pool there was a hope for a target sample size of around 250 study participants per state. Please see Section C starting on page 5 of the User Guide for further information.
description: Datasets: 
DS0: Study-Level Files
DS1: Survey Data
DS2: Medication Data
DS3: Intervention Adherence Data
description: English speaking adults with opioid-treated chronic low back pain.
description: paper and pencil interview (PAPI); telephone interview; web-based surveyThe variable <strong>PARTICIPANT_ID</strong> can be used to link the individual files together. Each of the three data files contains the same 770 cases.