DOI: 10.5064/f6qgjhi9
title: Data For: Mind Your Pain: A Single-Arm Feasibility Study to Assess a Smartphone-Based Interoceptive Attention Training for Patients with Chronic Low Back Pain
title: Mind Your Pain

description: &lt;h3&gt; Project Overview &lt;/h3&gt;
&lt;p&gt; People commonly cope with chronic low back pain (cLBP) by ignoring and distraction. This study investigated whether mindful interoceptive exposure to the pain sensation itself and its phenomenological components can be an alternative approach. We conducted a single-arm feasibility study in patients with cLBP using a 2-minute attention exercise guided by a smartphone app several times per day over 8 weeks. We assessed feasibility, pre/post pain, function, and psychological parameters using mixed methods: standard questionnaires, ecological momentary assessment, and exit interviews that included micro-phenomenology technique and subsequent reflexive thematic qualitative analysis. Our conclusion was that mindful interoceptive exposure to the sensations of their cLBP using a 2-minute attention exercise with a phone app—rather than ignoring and distracting from it—may be a beneficial intervention for cLBP.&lt;/p&gt;
&lt;p&gt;More study details can be found at the &lt;u&gt;&lt;a href="https://clinicaltrials.gov/study/NCT06186193?id=NCT06186193"&gt;federal clinical trials registry. &lt;/a&gt;&lt;/u&gt; &lt;/p&gt;
description: &lt;h3&gt; Data and Data Collection Overview &lt;/h3&gt;
&lt;p&gt;We conducted a single-arm, mixed-methods study to assess the app’s feasibility, acceptability, and potential benefits for patients with clearly defined cLBP. We applied standard pain self-report outcomes, quantitative sensory testing (QST), and task-based functional magnetic resonance imaging (fMRI).&lt;/p&gt;
&lt;p&gt;Following IRB approval (20-32001), we enrolled patients from May 21st, 2021, until February 21st, 2023 with follow-up data collected until May 21, 2023. Participants were compensated for their time and incentivized by receiving 50 cents for each entry into the phone app.&lt;/p&gt;
&lt;p&gt;We recruited English-speaking men and woman aged 18-65 years old with cLBP defined according to the NIH Research Task Force Recommendation on Research Standards for cLBP – pain at least half the days in the past 6 months, by using 2 questions and a human figure drawing illustrating the pain region – through university newsletters, research and study websites, flyers, and social media. Participants were recruited from throughout the San Francisco Bay area. Average pain in the last month had to be at least 3 out of 10 on the numeric rating scale (NRS). Using the Multidimensional Assessment of Interoceptive Awareness scales (MAIA-2), we only included patients with a low level of interoceptive awareness and habitual distraction as the dominant pain coping style. This was defined as: a) a MAIA summary score below the population mean score of 3.41 [possible range 0-5] established in a large representative sample of primary care patients and b) a MAIA Non-Distraction score below 2.91 [possible range 0-5], the mean value plus standard deviation in the same sample. These criteria were chosen (a) to test our hypothesis that the mindful attention task will be able to increase below average interoceptive awareness in cLBP patients, who are used to distracting themselves from their pain experience, and (b) to avoid a potential ceiling effect. Participants had to own a smart phone.&lt;/p&gt;
&lt;p&gt;Potential participants who visited the study website could check their preliminary eligibility. If they agreed, they were screened over the phone by a clinical research coordinator. We excluded patients with current or history of spine infection, spine tumor, vertebral fracture, cauda equina syndrome, patients with substance abuse, significant mental health, or other medical conditions (malignancies, liver failure, renal failure, pain conditions from inflammatory diseases, malignancies, abdominal aortic aneurysm, muscle weakness from radiculopathy). Radiculopathy or sciatic pain was not excluded if the condition was stable and did not lead to significant movement restrictions or muscle weakness. Regular opioid or antidepressant prescription was not an exclusion if stable over the past three months. We excluded patients involved in a lawsuit or worker's compensation claim related to their back; patients who received steroid or Botox injections near the spine in the past three months; women who were pregnant, planning to get pregnant in the next months, or were less than three months post-partum. Because all participants underwent task-based brain fMRIs, we excluded colorblind and left-handed patients and patients with other typical MRI-related exclusion criteria.&lt;/p&gt;
&lt;p&gt;The discussion of the electronic consent occurred by Zoom. Final eligibility was determined after answering the MAIA. After signing electronic informed consent, participants received a copy and answered questionnaires on-line at home.&lt;/p&gt;
&lt;p&gt;We enrolled 31 participants, mostly female, mean age 48, the majority had pain for &gt;5 years; 29 of them completed the full study. Both the qualitative and quantitative data shared here come from these 29 participants.&lt;/p&gt;
&lt;p&gt;All questionnaire data were collected online using the Research Electronic Data Capture (REDCap), a web-based, secure application that includes components for developing and implementing online surveys for clinical research, within 1-2 weeks before the start of the intervention and within 1-2 weeks after the 8-week intervention.&lt;/p&gt;
&lt;p&gt;Following the completion of the 8-week intervention, we conducted individual exit interviews with all participants and asked open -ended questions about the experience with the phone app, the attention task, its perceived usefulness and shortcomings, new insights and potential changes in their pain managements, and ways to improve the app. If participants agreed, a second part of the interview was an in-depth inquiry into the participants’ individual perception of pain using micro-phenomenological interview technique. With this technique the interviewer guides the participant gently away from thoughts and judgements about an experience into the immediacy of sensory experience itself. The interviewer was not aware of the interviewees’ questionnaire responses. The interviews were recorded and transcribed, as well as de-identified later.&lt;/p&gt;

&lt;h3&gt; Description of Intervention &lt;/h3&gt;
&lt;p&gt; The Mind your Pain study intervention (MyP) consists of an individual 1-hour educational introduction session over Zoom, a six-page illustrated handout summarizing the discussed pain education and a 1- to 2-minute attention task subsequently performed several times per day over 8 weeks. The 8-week intervention started with the 1-hour education session. We did not include the educational material in the phone app, as we did not have the resources for a thorough and effective implementation. In the last minutes of this education session, the task was downloaded on a smart phone app with notifications twice per day according to participant preferences. In addition, participants were asked to use the app whenever they perceive the pain at its worst. The app included an ecological momentary assessment (EMA) of pain intensity and interference each answered on a 0-10 NRS followed by a brief audio recording guiding the participant to attend to pain as the sensation “where it is the most intense”. The audio recording aimed to guide the participants’ attention focus into the center of “the sensation we call pain” in a detached and equanimous way and asked participants to carefully observe and explore it with curiosity in regards to five components of that sensation: feeling tone (sharp versus dull), motion (static versus movement/change), temperature (cold versus hot); density (tense/tight versus loose), and clarity of the borders of the perceived three-dimensional shape (diffuse versus clearly-defined). An optional entry field was offered for participants to add other experiential characteristics of their pain experience. The app was self-scheduled by the participants to provide one notification in the morning and one in the evening and used a Qualtrics survey platform to enter data directly to a secure UCSF server. While the app is not otherwise available publicly, we pretested a prototype of the app for iPhones and Android phones with ten cLBP patients. Brief weekly phone calls by the clinical research coordinator were provided to resolve logistic or technical issues and answer conceptual questions. &lt;/p&gt;
description: &lt;h3&gt; Selection and Organization of Shared Data &lt;/h3&gt;
&lt;p&gt;The data files shared here consist of 29 de-identified interview transcripts (from all participants who completed the whole study) and their respective survey responses. Three iterations of the team’s thematic coding of the qualitative materials combine analysis and data excerpts from the individual interviews and are thus classified as data files as well.&lt;/p&gt;
&lt;p&gt; The interview transcript file names use a participant ID number which corresponds to the participant’s responses in the quantitative survey. &lt;/p&gt;
&lt;p&gt; The documentation files consist of the study informed consent form, the interview guide, educational materials that accompanied the study app, survey data dictionary, this data narrative, and an administrative README file. &lt;/p&gt;