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The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GetActive-Fitbit
Healthy Living for Pain
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Physical Function, Mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male and female outpatients, age 18 years or older Fluent in English Have nonmalignant chronic musculoskeletal pain for more than 3 months Able to perform a 6-minute walk test (6MWT) Owns a smartphone with Bluetooth 4.0 or computer Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol. Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose Low-level of activity (must meet 2/3 criteria; if difficult to assess, recruiter may ask participant to report their recent step data from their smartphone to better understand their activity level) Sitting for more than 8 hours/day per self-report Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report Walking for fewer than 7 days/week (30+min of walking constitutes a "walking day") per self-report Exclusion Criteria: Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy) Serious mental illness or instability for which hospitalization may be likely in the next 6 months Current active suicidal ideation reported on self-report Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for >45 min 3 times/week within the last 3 months or less. Regular use of Fitbit DMD in the last 3 months Unable to walk/in a wheelchair Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors).

Sites / Locations

  • Rush Medical Center
  • Massachusetts General HospitalRecruiting
  • Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GetActive-Fitbit

Healthy Living for Pain

Arm Description

GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking.

Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling.

Outcomes

Primary Outcome Measures

Recruitment feasibility (ability)
Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Recruitment feasibility (timeliness)
Timeliness of enrollment; we will recruit a sample of 90 patients across the 3 sites over the course of 1 year. Participants will be considered enrolled upon attending Session 1.
Feasibility of recruitment racial and ethnic minorities
38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution.
Intervention feasibility/ adherence to sessions
≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Credibility and Expectancy Scale
≥80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention credibility
Client Satisfaction Scale
≥80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention satisfaction
Retention
≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants).
Assessment feasibility
≥90 accuracy of standardized protocol checklists for all assessments.
Adherence to Accelerometer
Daily wear of charged ActiGraph GT9X for GetActive-Fitbit Daily wear of Actigraph accelerometer for baseline and follow-up assessments.

Secondary Outcome Measures

Pain, Enjoyment of Life and General Activity (PEG-3) Scale
Rate of a participant's pain intensity and related interference in enjoyment of life and general activity, using a 0-10 Likert scale
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. Each question on the scale is measured 0-4, with higher scores indicating more disability.
6 Minute Walk Test (6MWT)
The 6MWT is a performance-based measure that assesses physical function and endurance.
ActiGraph GT9X
The ActiGraph GT9X is a step count device that objectively measures function (number of steps).
PROMIS depression v1.08b
The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale, with higher scores indicating more depressive symptoms
PROMIS anxiety v1.08a
The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms, with higher scores indicating more anxiety symptoms
Pain Catastrophizing Scale (PCS)
A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Higher scores indicate higher pain catastrophizing
Tampa Kinesiophobia Scale (TSK)
A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia
Measure of Current Status (MOCS)
The MOCS questionnaire assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Higher scores indicate a stronger ability to recognize stress and cope
Cognitive and Affective Mindfulness Scale (CAMS)
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4. Higher values reflect higher levels of mindfulness
Modified Global Impression of Change (MGIC)
2-item assessing the extent to which patients perceive the intervention improved functioning and symptoms.

Full Information

First Posted
January 17, 2023
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Rush University Medical Center, Duke University, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05700383
Brief Title
The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain
Official Title
The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain: Multi-site Feasibility RCT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Rush University Medical Center, Duke University, National Center for Complementary and Integrative Health (NCCIH)

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 investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program compared to a health education program for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person.
Detailed Description
The investigators aim to conduct a randomized controlled trial to test the feasibility of a mind-body walking program (GetActive-Fitbit) compared to a health education program (Healthy Living for Pain) for individuals with chronic musculoskeletal pain. The investigators will assess the feasibility of recruitment procedures (enrollment, recruitment of racial and ethnic minorities) and intervention delivery (fidelity, adherence, credibility, satisfaction, optimization), following pre-specified benchmarks. Both programs will be delivered in-person. Each program will consist of ten 60-minute sessions in-person. Participants will receive a treatment manual and ActiGraph watch to assess physical function. There are 3 assessment points consisting of self-report surveys and performance-based measures: baseline, post-program, and 6-month follow-up. All participants will receive access to the other program's manual and website after completing the six-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, Physical Function, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GetActive-Fitbit
Arm Type
Experimental
Arm Description
GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking.
Arm Title
Healthy Living for Pain
Arm Type
Active Comparator
Arm Description
Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling.
Intervention Type
Behavioral
Intervention Name(s)
GetActive-Fitbit
Intervention Description
GetActive-Fitbit is an adaptation of the original GetActive-Fitbit program, a mind-body program for the unique needs of individuals with chronic musculoskeletal pain that incorporates activity skills to help individuals improve all aspects of physical function. The GetActive-Fitbit sessions address mind-body skills (e.g., mindfulness, deep breathing, self-compassion), walking skills (e.g., step goals, quota-based pacing), and skills to change thinking (e.g., identify unhelpful thoughts about pain and activity, challenging thoughts). The format is a 10-week program delivered in-person with weekly group sessions and home practice of skills and walking.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Living for Pain
Intervention Description
Healthy Living for Pain is an active intervention that will be dose, attention, and time matches to the GetActive-Fitbit program. Healthy Living for Pain is an adaptation of the Health Enhancement Program, developed by Dr. Vranceanu and colleagues from Stony Brook, with adjustments for patients with chronic musculoskeletal pain. The Healthy Living for Pain sessions provide educational information on chronic musculoskeletal pain, the role of sleep and nutrition, physical activity, healthcare management, medication use, and social connection. The format is a 10-week program delivered in-person with weekly group sessions and home practice journaling.
Primary Outcome Measure Information:
Title
Recruitment feasibility (ability)
Description
Ability to enroll 80% or more of the sedentary chronic pain patients who meet study criteria.
Time Frame
1 Year
Title
Recruitment feasibility (timeliness)
Description
Timeliness of enrollment; we will recruit a sample of 90 patients across the 3 sites over the course of 1 year. Participants will be considered enrolled upon attending Session 1.
Time Frame
1 Year
Title
Feasibility of recruitment racial and ethnic minorities
Description
38% or more of the entire sample will be comprised of racial and ethnic minorities, which is consistent with the current USA demographic distribution.
Time Frame
1 Year
Title
Intervention feasibility/ adherence to sessions
Description
≥80 chronic pain patients attend ≥7/10 sessions for each program (70%)
Time Frame
Post-Test (10 Weeks)
Title
Credibility and Expectancy Scale
Description
≥80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention credibility
Time Frame
Baseline (0 Weeks)
Title
Client Satisfaction Scale
Description
≥80 chronic pain patients with credibility scores higher than the scale's mid point, indicating intervention satisfaction
Time Frame
Post-Test (10 Weeks)
Title
Retention
Description
≥80 post-treatment, ≥75% 6 months follow up for self-report, performance based and Actigraph data (this includes valid data for all participants).
Time Frame
1 Year
Title
Assessment feasibility
Description
≥90 accuracy of standardized protocol checklists for all assessments.
Time Frame
1 Year
Title
Adherence to Accelerometer
Description
Daily wear of charged ActiGraph GT9X for GetActive-Fitbit Daily wear of Actigraph accelerometer for baseline and follow-up assessments.
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Secondary Outcome Measure Information:
Title
Pain, Enjoyment of Life and General Activity (PEG-3) Scale
Description
Rate of a participant's pain intensity and related interference in enjoyment of life and general activity, using a 0-10 Likert scale
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 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. Each question on the scale is measured 0-4, with higher scores indicating more disability.
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
6 Minute Walk Test (6MWT)
Description
The 6MWT is a performance-based measure that assesses physical function and endurance.
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
ActiGraph GT9X
Description
The ActiGraph GT9X is a step count device that objectively measures function (number of steps).
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
PROMIS depression v1.08b
Description
The PROMIS depression v1.08b measures negative mood, views of self and cognitions on a 5-point scale, with higher scores indicating more depressive symptoms
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
PROMIS anxiety v1.08a
Description
The PROMIS anxiety v1.08a measures fear, worry, hyperarousal and somatic symptoms, with higher scores indicating more anxiety symptoms
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
Pain Catastrophizing Scale (PCS)
Description
A 13-item questionnaire assessing one's tendency to focus on pain-related thoughts and feel helpless and hopeless due to pain on a scale of 0 to 4. Higher scores indicate higher pain catastrophizing
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
Tampa Kinesiophobia Scale (TSK)
Description
A 17-item questionnaire that assesses fear avoidance and fear of activity. Higher scores indicate higher kinesiophobia
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
Measure of Current Status (MOCS)
Description
The MOCS questionnaire assesses ability to engage in a series of healthy coping skills (e.g., relaxation, social support, adaptive thinking). Higher scores indicate a stronger ability to recognize stress and cope
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
Cognitive and Affective Mindfulness Scale (CAMS)
Description
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4. Higher values reflect higher levels of mindfulness
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)
Title
Modified Global Impression of Change (MGIC)
Description
2-item assessing the extent to which patients perceive the intervention improved functioning and symptoms.
Time Frame
Baseline (0 Weeks), Post-Test (10 Weeks), Follow-Up (24 Weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female outpatients, age 18 years or older Fluent in English Have nonmalignant chronic musculoskeletal pain for more than 3 months Able to perform a 6-minute walk test (6MWT) Owns a smartphone with Bluetooth 4.0 or computer Willingness and ability to participate in one of the 2 programs and to comply with the requirements of the study protocol. Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose Low-level of activity (must meet 2/3 criteria; if difficult to assess, recruiter may ask participant to report their recent step data from their smartphone to better understand their activity level) Sitting for more than 8 hours/day per self-report Exercising for fewer than 3 days/week (30+min of exercise constitutes an "exercise day") per self-report Walking for fewer than 7 days/week (30+min of walking constitutes a "walking day") per self-report Exclusion Criteria: Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy) Serious mental illness or instability for which hospitalization may be likely in the next 6 months Current active suicidal ideation reported on self-report Untreated and/or unstable schizophrenia, bipolar disorder, or other psychotic disorder Current, active substance abuse or dependence, and current alcohol dependence within the past 6 months Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for >45 min 3 times/week within the last 3 months or less. Regular use of Fitbit DMD in the last 3 months Unable to walk/in a wheelchair Mild cognitive decline for participants 65+ only (Short Portable Mental Status Questionnaire; PMSQ 4 or more errors).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana-Maria Vranceanu, PhD
Phone
617-724-4977
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Greenberg, PhD
Phone
617-643-9402
Email
jgreenberg5@mgh.harvard.edu
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
Rush Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Burns, PhD
Email
john_burns@rush.edu
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Greenberg, PhD
Email
jgreenberg5@mgh.harvard.edu
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Somers, PhD
Email
tamara.somers@duke.edu

12. IPD Sharing Statement

Learn more about this trial

The Thrive Study: Improving Multimodal Physical Function in Adults With Heterogenous Chronic Pain

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