Clinical trial NCT03412916: Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain
Official title: Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Chronic Pain
Physical Activity
Keywords: Chronic Pain
Physical Activity
Mind-body
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study are to adapt, pilot, and examine the credibility, acceptability, and feasibility of an evidence-based mind-body program, the Relaxation Response Resiliency Program for Chronic Pain (p3RP), and the p3RP-Digital Monitoring Device (p3RP-DMD), which is the p3RP integrated with a commercial DMD, the Fitbit.

Detailed description: The study has three phases. In phase I, the investigators are adapting the 3RP as a multidisciplinary team, and then conducting two focus groups. In phase two, the investigators are piloting the p3RP and p3RP-DMD. In phase three, the investigators are conducting a small randomized-controlled trial of the p3RP versus p3RP-DMD.

Eligibility criteria: Inclusion Criteria:

* Male and female patients, age 18 years or older
* Have nonmalignant chronic pain for more than 3 months
* Able to perform a 6-minute walk test
* Owns a smartphone with Bluetooth 4.0
* Willingness and ability to participate in the 3RP intervention and to comply with the requirements of the study protocol (including weekly sessions and DMD use)
* Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
* Cleared by a medical doctor for study participation
* Leads a sedentary lifestyle

Exclusion Criteria:

* Diagnosed with medical illness expected to worsen in the next 6 months
* Serious mental illness or instability for which hospitalization may be likely in the next 6 months
* Current suicidal ideation reported on self-report
* Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
* Current substance use disorder, within the past 6 months
* Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
* Regular use of DMD in the last 3 months
* Engagement in regular intensive physical exercise for \>30 minute daily
* Unable to walk without use of assistance (e.g., wheelchair, walker)

Primary outcomes:
measure: Change in Client Satisfaction Questionnaire 3-Item (CSQ-3)
timeFrame: Post-Test (10 Weeks)
Secondary outcomes:
measure: Adherence to DMD
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks)
measure: Adherence to Homework
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks)
measure: Therapist Adherence to Sessions
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks)
measure: Feasibility of Quantitative Measures
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks)
measure: Rescue (Non-Narcotic) Analgesic Use
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks)
measure: Narcotic Analgesic Use
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks)
measure: Adverse Events
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks)
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline (0 Weeks)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: PROMIS Physical Function v.8b
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: Physical Activity Scale for Persons with Physical Disabilities (PASIPD)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: WHO Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: Numerical Rating Scale
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: Pain Resilience Scale (PRS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: PROMIS Depression v.8b
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: PROMIS Anxiety v.8a
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: PROMIS Social Isolation v.4a
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: PROMIS Emotional Support v.4a
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: Tampa Kinesiophobia Scale (TKS)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: Measure of Current Status (MOCS-A)
timeFrame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
measure: Patient Global Impression of Change (PGIC)
timeFrame: Post-Test (10 Weeks)
measure: Post-Test Feasibility Questions
timeFrame: Post-Test (10 Weeks)
measure: 3-Month Follow Up Questions
timeFrame: 3-Month Follow-Up (23 Weeks)
Other outcomes:
measure: Date of birth, age, gender, ethcnitiy, race, martial status, education level, employment status, type of job, income, pain diagnoses, length of chronic pain, other medical conditions, mental health conditions, pain medications, psychiatric medications
timeFrame: Baseline (0 Weeks)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hopkins SW, Greenberg J, Isaacs J, Vranceanu AM. "Practice Makes Perfect"? Associations Between Home Practice and Physical and Emotional Function Outcomes Among Patients with Chronic Pain Enrolled in a Mind-Body Program. J Integr Complement Med. 2022 Apr;28(4):320-327. doi: 10.1089/jicm.2021.0324. Epub 2022 Feb 28.
citation: Greenberg J, Singh T, Popok PJ, Kulich RJ, Vranceanu AM. Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain. Int J Behav Med. 2021 Dec;28(6):820-826. doi: 10.1007/s12529-021-09971-3. Epub 2021 Mar 2.
citation: Greenberg J, Mace RA, Bannon SM, Kulich RJ, Vranceanu AM. Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function. J Pain Res. 2021 Feb 5;14:359-368. doi: 10.2147/JPR.S298212. eCollection 2021.
citation: Bannon S, Greenberg J, Mace RA, Locascio JJ, Vranceanu AM. The role of social isolation in physical and emotional outcomes among patients with chronic pain. Gen Hosp Psychiatry. 2021 Mar-Apr;69:50-54. doi: 10.1016/j.genhosppsych.2021.01.009. Epub 2021 Jan 28.
citation: Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007/s10880-020-09758-w. Epub 2021 Jan 19.
citation: Greenberg J, Mace RA, Popok PJ, Kulich RJ, Patel KV, Burns JW, Somers TJ, Keefe FJ, Schatman ME, Vranceanu AM. Psychosocial Correlates of Objective, Performance-Based, and Patient-Reported Physical Function Among Patients with Heterogeneous Chronic Pain. J Pain Res. 2020 Sep 10;13:2255-2265. doi: 10.2147/JPR.S266455. eCollection 2020.
citation: Greenberg J, Popok PJ, Lin A, Kulich RJ, James P, Macklin EA, Millstein RA, Edwards RR, Vranceanu AM. A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial. JMIR Form Res. 2020 Jun 8;4(6):e18703. doi: 10.2196/18703.