Integrating Mind-Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Chronic Pain

Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Chronic Pain; Physical Activity
• Intervention / Treatment: Behavioral: GetActive; Behavioral: Get Active with 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GetActive; The GetActive program uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The GetActive sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is a 10-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions.	Behavioral: GetActive; GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.; Other Names: The Relaxation Response Resiliency Program for Pain
Experimental: GetActive with Fitbit; The GetActive with Fitbit is identical to that of the p3RP with the addition of a digital monitoring device (i.e., Fitbit) for recording of physical activity.	Behavioral: Get Active with Fitbit; The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.; Other Names: The Relaxation Response Resiliency Program for Pain with DMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Client Satisfaction Questionnaire 3-Item (CSQ-3)	Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.	Post-Test (10 Weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to DMD	Rate of participant's use of DMD throughout the study	Baseline (0 Weeks), Post-Test (10 Weeks)
Adherence to Homework	Rate of participant's completion of homework assigned throughout the study	Baseline (0 Weeks), Post-Test (10 Weeks)
Therapist Adherence to Sessions	Rate of interventionist's delivering the programs by following the established session topics and skills	Baseline (0 Weeks), Post-Test (10 Weeks)
Feasibility of Quantitative Measures	Rate of participant's completion of self-report measures	Baseline (0 Weeks), Post-Test (10 Weeks)
Rescue (Non-Narcotic) Analgesic Use	Single-item question on demographics form	Baseline (0 Weeks), Post-Test (10 Weeks)
Narcotic Analgesic Use	Single-item question on demographics form	Baseline (0 Weeks), Post-Test (10 Weeks)
Adverse Events	any self reported or observed negative events related to participation	Baseline (0 Weeks), Post-Test (10 Weeks)
Credibility and Expectancy Questionnaire (CEQ)	Measures how much one thinks the intervention will work	Baseline (0 Weeks)
Pittsburgh Sleep Quality Index (PSQI)	Measures one's sleep quality	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
PROMIS Physical Function v.8b	The 8-item scale assesses for how difficult it is for one to perform daily living activities	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Physical Activity Scale for Persons with Physical Disabilities (PASIPD)	The PASIPD measures one's level of physical activity and exercise in the past 7 days	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
WHO Disability Assessment Schedule 2.0 (WHODAS)	The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Numerical Rating Scale	Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Pain Resilience Scale (PRS)	The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
PROMIS Depression v.8b	The 8-item scale measures depressive symptoms over the past week	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
PROMIS Anxiety v.8a	The 8-item scale measures fear and worry over the past week	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
PROMIS Social Isolation v.4a	The 4-item scale measures how often one perceives feeling apart from others and excluded.	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
PROMIS Emotional Support v.4a	The 4-item scale measures how often one feels valued and confidant has relationships	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Cognitive and Affective Mindfulness Scale (CAMS)	The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Pain Catastrophizing Scale (PCS)	The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. A higher score indicates more catastrophizing	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Tampa Kinesiophobia Scale (TKS)	The TKS is a 17-item scale that measures one's fear of movement, with a greater score indicating greater fear	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Measure of Current Status (MOCS-A)	The MOCS-A, a 13-item scale, measures one's perceived ability to perform various skills that the intervention aims to target	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Patient Global Impression of Change (PGIC)	The PGIC assesses clinically important change from baseline to post-test	Post-Test (10 Weeks)
Post-Test Feasibility Questions	Assesses how helpful components of the intervention were	Post-Test (10 Weeks)
3-Month Follow Up Questions	Assesses for physical activity in the DMD group	3-Month Follow-Up (23 Weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This questionnaire asks individuals to report on 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	Baseline (0 Weeks)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Chronic Pain; Mind-body
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2017P000628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No