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

Primary Purpose

Pain, Chronic Pain, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GetActive
Get Active with Fitbit
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Chronic Pain, Physical Activity, Mind-body

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GetActive

GetActive with Fitbit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adherence to DMD
Rate of participant's use of DMD throughout the study
Adherence to Homework
Rate of participant's completion of homework assigned throughout the study
Therapist Adherence to Sessions
Rate of interventionist's delivering the programs by following the established session topics and skills
Feasibility of Quantitative Measures
Rate of participant's completion of self-report measures
Rescue (Non-Narcotic) Analgesic Use
Single-item question on demographics form
Narcotic Analgesic Use
Single-item question on demographics form
Adverse Events
any self reported or observed negative events related to participation
Credibility and Expectancy Questionnaire (CEQ)
Measures how much one thinks the intervention will work
Pittsburgh Sleep Quality Index (PSQI)
Measures one's sleep quality
PROMIS Physical Function v.8b
The 8-item scale assesses for how difficult it is for one to perform daily living activities
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
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
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
Pain Resilience Scale (PRS)
The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain
PROMIS Depression v.8b
The 8-item scale measures depressive symptoms over the past week
PROMIS Anxiety v.8a
The 8-item scale measures fear and worry over the past week
PROMIS Social Isolation v.4a
The 4-item scale measures how often one perceives feeling apart from others and excluded.
PROMIS Emotional Support v.4a
The 4-item scale measures how often one feels valued and confidant has relationships
Cognitive and Affective Mindfulness Scale (CAMS)
The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings
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
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
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
Patient Global Impression of Change (PGIC)
The PGIC assesses clinically important change from baseline to post-test
Post-Test Feasibility Questions
Assesses how helpful components of the intervention were
3-Month Follow Up Questions
Assesses for physical activity in the DMD group

Full Information

First Posted
January 12, 2018
Last Updated
November 14, 2019
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03412916
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain, Physical Activity
Keywords
Chronic Pain, Physical Activity, Mind-body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35231185
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.
Results Reference
derived
PubMed Identifier
33649888
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.
Results Reference
derived
PubMed Identifier
33574699
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.
Results Reference
derived
PubMed Identifier
33540223
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.
Results Reference
derived
PubMed Identifier
33469845
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.
Results Reference
derived
PubMed Identifier
32982388
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.
Results Reference
derived
PubMed Identifier
32348281
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.
Results Reference
derived

Learn more about this trial

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

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