Chronic Pain, Pain, Physical Activity
Conditions
Keywords
Chronic Pain, Physical Activity, Mind-body
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint | Post-Test (10 Weeks) | Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. |
| Therapist Adherence | Collected during the intervention | Two independent coders rated whether clinicians delivered each component of study sessions (e.g., deep breathing, providing education on prevalent myths about chronic pain) , exhibited skillful delivery (e.g., active listening, validation), and followed study protocol (e.g., collecting home practice sheets, logging attendance). Each individual component was rated on a yes/no scale. The adherent (yes) components were summed, tallied against the total number of components in the adherence checklist, and averaged between the 2 reviewers. The score represents a total rate of adherence. |
| Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Baseline (0 Weeks), Post-Test (10 Weeks) | Rate of participant's use of ActiGraph watch for a period of one week at both baseline and post-treatment assessments. A valid day of wear consisted of at least 7 hours of wear time. |
| Program Safety - Number of Adverse Events Related to Study Participation | Baseline (0 Weeks), Post-Test (10 Weeks) | Any self-reported or observed negative events related to participation. |
| Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria | Baseline (0 Weeks), Post-Test (10 Weeks) | Rate of participant's completion of homework assigned throughout the study. Logs were considered adherent if participants completed 3 home practice components 3 out of 7 days per week or 1 home practice component 5 out of 7 days per week. |
| Feasibility of Quantitative Measures | Baseline (0 Weeks), Post-Test (10 Weeks) | The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments. |
| Credibility and Expectancy Questionnaire (CEQ) | Baseline (0 Weeks) | Number of participants who score above the midpoint on two subscales assessed using frequencies and proportions. The measure involves two subscales: credibility (questions 1-3) and expectancy (questions 4-6). Subscale scores range from 3 to 27. Higher scores indicate greater perceived credibility and greater belief that treatment will help. |
| Program Acceptability | Post-Test (10 Weeks) | Assessed via the percentage of participants who attended at least 7 out of 10 sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Resilience Scale (PRS) | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain. Scores range from 0 to 56. Higher scores indicate greater resilience. |
| Numerical Rating Scale | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | Measures pain at rest and pain with activity on a Likert scale with 0 being no pain and 10 being the worst pain ever |
| Cognitive and Affective Mindfulness Scale (CAMS) | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings. Items range from 1 to 4. Total scores range from 12 to 48. Higher values reflect higher levels of mindfulness. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | Measures one's sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality. |
| 6-Min Walk Test Distance | 6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks). | Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes. |
| Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The 4-item scale measures perceived emotional support. Raw scores range from 4 to 20. Scaled scores range from 25.7 to 62. Higher score indicate greater emotional support. |
| Pain Catastrophizing Scale (PCS) | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. Total scores range from 0 to 52. A higher score indicates more catastrophizing. |
| Tampa Kinesiophobia Scale (TKS) | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The TKS is a 17-item scale that measures one's fear of movement, with a greater score indicating greater fear of injury due to movement. Scores range from 11 to 44. |
| Measure of Current Status (MOCS-A) | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The MOCS-A, a 13-item scale, measures one's perceived ability to perform various skills that the intervention aims to target. Scores range from 0 to 52. Higher scores indicate greater perceived ability. |
| Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The 4-item scale measures how often one perceives feeling apart from others and excluded. Raw scores range from 4 to 20. Scaled scores range from 34.8 to 74.2. Higher scores indicate greater social isolation. |
| ActiGraph Average Steps | 1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks) | Average steps counted for using the wGT3X-BT ActiGraph accelerometer device. Daily step counts were collected using the device for a week at each assessment period. A weekly average was calculated from the daily totals. |
| Patient Global Impression of Change (PGIC) | Post-Test (10 Weeks) | The PGIC assesses clinically important change in symptoms since beginning treatment. Each of the 6 items assesses a different treatment target. Items are assessed on a scale of 0 to 6. Lower scores indicate greater symptom improvement. |
| Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The PASIPD is a 13-item measure that assesses one's level of physical activity and exercise in the past 7 days. Scores range from 0 to 100. Higher scores indicate greater activity. |
| WHO Disability Assessment Schedule 2.0 (WHODAS) | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The WHODAS measures level of functioning in six domains: cognition, mobility, self-care, getting along, life activities, and participation. Scores range from 0 to 100. Higher scores indicate more disability. |
| Patient-Reported Outcomes Measurement Information System Physical Function v.8b | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The 8-item scale assesses for how difficult it is for one to perform daily living activities. Raw scores range from 8 to 40. T scores range from 20.3 to 60.1. Higher scores indicate better physical function and ability to perform activities of daily living. |
| Patient-Reported Outcomes Measurement Information System Anxiety v.8a | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The 8-item scale measures fear and worry over the past week. Raw scores range from 8 to 40. T-scores range from 37.1 to 83.1. Higher scores indicate higher levels of anxiety. |
| Patient-Reported Outcomes Measurement Information System Depression v.8b | Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) | The 8-item scale measures depressive symptoms over the past week. Raw scores range from 8 to 40 and t scores range from 37.1 to 82.4. Higher scores indicate greater depressive symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 41 |
| 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.
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. | 41 |
| Total | 82 |
Baseline characteristics
| Characteristic | GetActive | GetActive With Fitbit | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 34 Participants | 66 Participants |
| Age, Continuous | 54.46 years STANDARD_DEVIATION 14.5 | 49.07 years STANDARD_DEVIATION 14.2 | 51.77 years STANDARD_DEVIATION 14.53 |
| Education Completed college (16 years) | 9 Participants | 8 Participants | 17 Participants |
| Education Graduate/professional degree (>16 years) | 12 Participants | 16 Participants | 28 Participants |
| Education High school (12 years) | 5 Participants | 6 Participants | 11 Participants |
| Education Some college/associate degree (<16 years) | 15 Participants | 11 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 37 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Marital status Living with significant other | 5 Participants | 6 Participants | 11 Participants |
| Marital status Married | 15 Participants | 8 Participants | 23 Participants |
| Marital status Separated/divorced | 5 Participants | 11 Participants | 16 Participants |
| Marital status Single, never married | 13 Participants | 15 Participants | 28 Participants |
| Marital status Widowed | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 34 Participants | 66 Participants |
| Sex: Female, Male Female | 23 Participants | 31 Participants | 54 Participants |
| Sex: Female, Male Male | 18 Participants | 10 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 37 |
| other Total, other adverse events | 3 / 35 | 7 / 37 |
| serious Total, serious adverse events | 1 / 35 | 1 / 37 |
Outcome results
Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days
Rate of participant's use of ActiGraph watch for a period of one week at both baseline and post-treatment assessments. A valid day of wear consisted of at least 7 hours of wear time.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
Population: The number of participants who received an ActiGraph at post-tests was fewer than baselines because of patients discontinuing participation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GetActive | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Baseline | Who received the ActiGraph and wore it for ≥ 5 out of 7 days | 31 Participants |
| GetActive | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Baseline | Who received the ActiGraph and wore it for < 5 out of 7 days | 2 Participants |
| GetActive | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Post-Test | Who received the ActiGraph and wore it for ≥ 5 out of 7 days | 25 Participants |
| GetActive | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Post-Test | Who received the ActiGraph and wore it for < 5 out of 7 days | 2 Participants |
| GetActive With Fitbit | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Post-Test | Who received the ActiGraph and wore it for < 5 out of 7 days | 4 Participants |
| GetActive With Fitbit | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Baseline | Who received the ActiGraph and wore it for ≥ 5 out of 7 days | 36 Participants |
| GetActive With Fitbit | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Post-Test | Who received the ActiGraph and wore it for ≥ 5 out of 7 days | 29 Participants |
| GetActive With Fitbit | Adherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 Days | Baseline | Who received the ActiGraph and wore it for < 5 out of 7 days | 3 Participants |
Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria
Rate of participant's completion of homework assigned throughout the study. Logs were considered adherent if participants completed 3 home practice components 3 out of 7 days per week or 1 home practice component 5 out of 7 days per week.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GetActive | Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria | participants that completed logs handed in met adherence criteria | 34 Participants |
| GetActive | Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria | participants that completed logs handed in that did not meet adherence criteria | 1 Participants |
| GetActive With Fitbit | Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria | participants that completed logs handed in met adherence criteria | 36 Participants |
| GetActive With Fitbit | Adherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteria | participants that completed logs handed in that did not meet adherence criteria | 1 Participants |
Credibility and Expectancy Questionnaire (CEQ)
Number of participants who score above the midpoint on two subscales assessed using frequencies and proportions. The measure involves two subscales: credibility (questions 1-3) and expectancy (questions 4-6). Subscale scores range from 3 to 27. Higher scores indicate greater perceived credibility and greater belief that treatment will help.
Time frame: Baseline (0 Weeks)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GetActive | Credibility and Expectancy Questionnaire (CEQ) | Expectancy | scored above the scale midpoint | 27 Participants |
| GetActive | Credibility and Expectancy Questionnaire (CEQ) | Expectancy | scored below the scale midpoint | 14 Participants |
| GetActive | Credibility and Expectancy Questionnaire (CEQ) | Credibility | scored above the scale midpoint | 37 Participants |
| GetActive | Credibility and Expectancy Questionnaire (CEQ) | Credibility | scored below the scale midpoint | 4 Participants |
| GetActive With Fitbit | Credibility and Expectancy Questionnaire (CEQ) | Credibility | scored below the scale midpoint | 3 Participants |
| GetActive With Fitbit | Credibility and Expectancy Questionnaire (CEQ) | Expectancy | scored above the scale midpoint | 22 Participants |
| GetActive With Fitbit | Credibility and Expectancy Questionnaire (CEQ) | Credibility | scored above the scale midpoint | 38 Participants |
| GetActive With Fitbit | Credibility and Expectancy Questionnaire (CEQ) | Expectancy | scored below the scale midpoint | 19 Participants |
Feasibility of Quantitative Measures
The number of participants that completed quantitative measures. Rate of participant's completion of self-report measures administered at baseline and post-test assessments.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GetActive | Feasibility of Quantitative Measures | 41 Participants |
| GetActive With Fitbit | Feasibility of Quantitative Measures | 40 Participants |
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GetActive | Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint | Scored above the scale midpoint | 34 Participants |
| GetActive | Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint | Scored below the scale midpoint | 0 Participants |
| GetActive With Fitbit | Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint | Scored above the scale midpoint | 35 Participants |
| GetActive With Fitbit | Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale Midpoint | Scored below the scale midpoint | 1 Participants |
Program Acceptability
Assessed via the percentage of participants who attended at least 7 out of 10 sessions.
Time frame: Post-Test (10 Weeks)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GetActive | Program Acceptability | Attended ≥7 out of 10 group or make-up sessions | 31 Participants |
| GetActive | Program Acceptability | Attended <7 out of 10 group or make-up sessions | 10 Participants |
| GetActive With Fitbit | Program Acceptability | Attended ≥7 out of 10 group or make-up sessions | 34 Participants |
| GetActive With Fitbit | Program Acceptability | Attended <7 out of 10 group or make-up sessions | 7 Participants |
Program Safety - Number of Adverse Events Related to Study Participation
Any self-reported or observed negative events related to participation.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GetActive | Program Safety - Number of Adverse Events Related to Study Participation | 0 adverse events |
| GetActive With Fitbit | Program Safety - Number of Adverse Events Related to Study Participation | 0 adverse events |
Therapist Adherence
Two independent coders rated whether clinicians delivered each component of study sessions (e.g., deep breathing, providing education on prevalent myths about chronic pain) , exhibited skillful delivery (e.g., active listening, validation), and followed study protocol (e.g., collecting home practice sheets, logging attendance). Each individual component was rated on a yes/no scale. The adherent (yes) components were summed, tallied against the total number of components in the adherence checklist, and averaged between the 2 reviewers. The score represents a total rate of adherence.
Time frame: Collected during the intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GetActive | Therapist Adherence | 94 percentage of adherence |
| GetActive With Fitbit | Therapist Adherence | 98 percentage of adherence |
6-Min Walk Test Distance
Recorded the distance in meters each participant covered by walking on a flat surface for 6 minutes.
Time frame: 6 minutes at baseline (0 Weeks), 6 minutes at post-test (10 Weeks).
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | 6-Min Walk Test Distance | Baseline | 346.244 Meters | Standard Error 13.684 |
| GetActive | 6-Min Walk Test Distance | Posttest | 389.492 Meters | Standard Error 12.95 |
| GetActive With Fitbit | 6-Min Walk Test Distance | Baseline | 331.866 Meters | Standard Error 13.898 |
| GetActive With Fitbit | 6-Min Walk Test Distance | Posttest | 385.872 Meters | Standard Error 12.691 |
ActiGraph Average Steps
Average steps counted for using the wGT3X-BT ActiGraph accelerometer device. Daily step counts were collected using the device for a week at each assessment period. A weekly average was calculated from the daily totals.
Time frame: 1 week at baseline (0 Weeks), 1 week at post-test (10 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | ActiGraph Average Steps | Baseline | 5621.095674 Steps | Standard Error 595.369 |
| GetActive | ActiGraph Average Steps | Posttest | 5606.226 Steps | Standard Error 600.898 |
| GetActive With Fitbit | ActiGraph Average Steps | Baseline | 5226.732 Steps | Standard Error 409.875 |
| GetActive With Fitbit | ActiGraph Average Steps | Posttest | 5271.760 Steps | Standard Error 391.723 |
Cognitive and Affective Mindfulness Scale (CAMS)
The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings. Items range from 1 to 4. Total scores range from 12 to 48. Higher values reflect higher levels of mindfulness.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Cognitive and Affective Mindfulness Scale (CAMS) | Baseline Mindfulness | 32.12 score on a scale | Standard Error 0.99 |
| GetActive | Cognitive and Affective Mindfulness Scale (CAMS) | Posttest Mindfulness | 36.09 score on a scale | Standard Error 1.07 |
| GetActive | Cognitive and Affective Mindfulness Scale (CAMS) | Three-Month follow-up Mindfulness | 35.95 score on a scale | Standard Error 1.09 |
| GetActive With Fitbit | Cognitive and Affective Mindfulness Scale (CAMS) | Baseline Mindfulness | 30.29 score on a scale | Standard Error 1.11 |
| GetActive With Fitbit | Cognitive and Affective Mindfulness Scale (CAMS) | Posttest Mindfulness | 33.07 score on a scale | Standard Error 1 |
| GetActive With Fitbit | Cognitive and Affective Mindfulness Scale (CAMS) | Three-Month follow-up Mindfulness | 34.08 score on a scale | Standard Error 1.36 |
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. Scores range from 0 to 52. Higher scores indicate greater perceived ability.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Measure of Current Status (MOCS-A) | Baseline Adaptive Coping | 27.56 score on a scale | Standard Error 1.49 |
| GetActive | Measure of Current Status (MOCS-A) | Posttest Adaptive Coping | 36.09 score on a scale | Standard Error 1.43 |
| GetActive | Measure of Current Status (MOCS-A) | Three-Month follow-up Adaptive Coping | 34.24 score on a scale | Standard Error 1.5 |
| GetActive With Fitbit | Measure of Current Status (MOCS-A) | Baseline Adaptive Coping | 27.27 score on a scale | Standard Error 1.5 |
| GetActive With Fitbit | Measure of Current Status (MOCS-A) | Posttest Adaptive Coping | 34.10 score on a scale | Standard Error 1.33 |
| GetActive With Fitbit | Measure of Current Status (MOCS-A) | Three-Month follow-up Adaptive Coping | 31.98 score on a scale | Standard Error 1.36 |
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
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Numerical Rating Scale | Baseline Pain at rest | 5.07 score on a scale | Standard Error 0.39 |
| GetActive | Numerical Rating Scale | Posttest Pain at rest | 3.73 score on a scale | Standard Error 0.41 |
| GetActive | Numerical Rating Scale | Follow up Pain at rest | 4.18 score on a scale | Standard Error 0.41 |
| GetActive | Numerical Rating Scale | Baseline Pain during activity | 6.93 score on a scale | Standard Error 0.31 |
| GetActive | Numerical Rating Scale | Posttest Pain during activity | 5.16 score on a scale | Standard Error 0.42 |
| GetActive | Numerical Rating Scale | Follow-up Pain during activity | 5.28 score on a scale | Standard Error 0.45 |
| GetActive With Fitbit | Numerical Rating Scale | Posttest Pain during activity | 6.01 score on a scale | Standard Error 0.41 |
| GetActive With Fitbit | Numerical Rating Scale | Baseline Pain at rest | 5.70 score on a scale | Standard Error 0.34 |
| GetActive With Fitbit | Numerical Rating Scale | Baseline Pain during activity | 7.15 score on a scale | Standard Error 0.34 |
| GetActive With Fitbit | Numerical Rating Scale | Posttest Pain at rest | 4.58 score on a scale | Standard Error 0.36 |
| GetActive With Fitbit | Numerical Rating Scale | Follow-up Pain during activity | 5.31 score on a scale | Standard Error 0.6 |
| GetActive With Fitbit | Numerical Rating Scale | Follow up Pain at rest | 4.30 score on a scale | Standard Error 0.5 |
Pain Catastrophizing Scale (PCS)
The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. Total scores range from 0 to 52. A higher score indicates more catastrophizing.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Pain Catastrophizing Scale (PCS) | Baseline | 19.71 score on a scale | Standard Error 1.84 |
| GetActive | Pain Catastrophizing Scale (PCS) | Posttest | 9.98 score on a scale | Standard Error 1.29 |
| GetActive | Pain Catastrophizing Scale (PCS) | Three-Month follow-up | 9.91 score on a scale | Standard Error 1.49 |
| GetActive With Fitbit | Pain Catastrophizing Scale (PCS) | Baseline | 22.27 score on a scale | Standard Error 1.89 |
| GetActive With Fitbit | Pain Catastrophizing Scale (PCS) | Posttest | 16.75 score on a scale | Standard Error 1.77 |
| GetActive With Fitbit | Pain Catastrophizing Scale (PCS) | Three-Month follow-up | 16.79 score on a scale | Standard Error 2.03 |
Pain Resilience Scale (PRS)
The PRS, a 14-item scale, measures pain resilience and how one would respond emotionally when faced with prolonged pain. Scores range from 0 to 56. Higher scores indicate greater resilience.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Pain Resilience Scale (PRS) | Baseline Pain resilience | 37.68 score on a scale | Standard Error 1.47 |
| GetActive | Pain Resilience Scale (PRS) | Posttest Pain resilience | 43.55 score on a scale | Standard Error 1.64 |
| GetActive | Pain Resilience Scale (PRS) | 3-Month follow- up Pain resilience | 45.02 score on a scale | Standard Error 1.39 |
| GetActive With Fitbit | Pain Resilience Scale (PRS) | Baseline Pain resilience | 32.51 score on a scale | Standard Error 1.58 |
| GetActive With Fitbit | Pain Resilience Scale (PRS) | Posttest Pain resilience | 36.19 score on a scale | Standard Error 1.82 |
| GetActive With Fitbit | Pain Resilience Scale (PRS) | 3-Month follow- up Pain resilience | 36.13 score on a scale | Standard Error 2.07 |
Patient Global Impression of Change (PGIC)
The PGIC assesses clinically important change in symptoms since beginning treatment. Each of the 6 items assesses a different treatment target. Items are assessed on a scale of 0 to 6. Lower scores indicate greater symptom improvement.
Time frame: Post-Test (10 Weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Patient Global Impression of Change (PGIC) | Impression of change in pain | 2.51 score on a scale | Standard Deviation 1.17 |
| GetActive | Patient Global Impression of Change (PGIC) | Impression of change in physical activity | 2.31 score on a scale | Standard Deviation 1.18 |
| GetActive | Patient Global Impression of Change (PGIC) | Impression of change in physical function | 2.57 score on a scale | Standard Deviation 1.19 |
| GetActive | Patient Global Impression of Change (PGIC) | Impression of change in emotional function | 2.40 score on a scale | Standard Deviation 1.01 |
| GetActive | Patient Global Impression of Change (PGIC) | Impression of change in resiliency | 2.14 score on a scale | Standard Deviation 0.91 |
| GetActive | Patient Global Impression of Change (PGIC) | Impression of change from use of Fitbit | NA score on a scale | — |
| GetActive With Fitbit | Patient Global Impression of Change (PGIC) | Impression of change in resiliency | 2.32 score on a scale | Standard Deviation 1.03 |
| GetActive With Fitbit | Patient Global Impression of Change (PGIC) | Impression of change in pain | 2.70 score on a scale | Standard Deviation 1.2 |
| GetActive With Fitbit | Patient Global Impression of Change (PGIC) | Impression of change in emotional function | 2.54 score on a scale | Standard Deviation 0.84 |
| GetActive With Fitbit | Patient Global Impression of Change (PGIC) | Impression of change in physical activity | 2.30 score on a scale | Standard Deviation 1.1 |
| GetActive With Fitbit | Patient Global Impression of Change (PGIC) | Impression of change from use of Fitbit | 1.86 score on a scale | Standard Deviation 0.95 |
| GetActive With Fitbit | Patient Global Impression of Change (PGIC) | Impression of change in physical function | 2.78 score on a scale | Standard Deviation 0.95 |
Patient-Reported Outcomes Measurement Information System Anxiety v.8a
The 8-item scale measures fear and worry over the past week. Raw scores range from 8 to 40. T-scores range from 37.1 to 83.1. Higher scores indicate higher levels of anxiety.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Patient-Reported Outcomes Measurement Information System Anxiety v.8a | Baseline | 53.50 score on a scale | Standard Deviation 1.58 |
| GetActive | Patient-Reported Outcomes Measurement Information System Anxiety v.8a | Posttest | 51.26 score on a scale | Standard Deviation 1.41 |
| GetActive | Patient-Reported Outcomes Measurement Information System Anxiety v.8a | Follow-up | 51.49 score on a scale | Standard Deviation 1.68 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Anxiety v.8a | Baseline | 59.33 score on a scale | Standard Deviation 1.39 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Anxiety v.8a | Posttest | 56.39 score on a scale | Standard Deviation 1.53 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Anxiety v.8a | Follow-up | 57.27 score on a scale | Standard Deviation 1.62 |
Patient-Reported Outcomes Measurement Information System Depression v.8b
The 8-item scale measures depressive symptoms over the past week. Raw scores range from 8 to 40 and t scores range from 37.1 to 82.4. Higher scores indicate greater depressive symptoms.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Patient-Reported Outcomes Measurement Information System Depression v.8b | Baseline | 53.14 score on a scale | Standard Error 1.69 |
| GetActive | Patient-Reported Outcomes Measurement Information System Depression v.8b | Posttest | 50.21 score on a scale | Standard Error 1.55 |
| GetActive | Patient-Reported Outcomes Measurement Information System Depression v.8b | Follow-up | 50.21 score on a scale | Standard Error 1.54 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Depression v.8b | Baseline | 60.02 score on a scale | Standard Error 1.45 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Depression v.8b | Posttest | 55.74 score on a scale | Standard Error 1.21 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Depression v.8b | Follow-up | 55.75 score on a scale | Standard Error 1.7 |
Patient-Reported Outcomes Measurement Information System Emotional Support v.4a
The 4-item scale measures perceived emotional support. Raw scores range from 4 to 20. Scaled scores range from 25.7 to 62. Higher score indicate greater emotional support.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | Baseline | 49.924 score on a scale | Standard Error 1.365 |
| GetActive | Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | Post-test | 53.078 score on a scale | Standard Error 1.604 |
| GetActive | Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | Follow-up | 53.425 score on a scale | Standard Error 1.417 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | Baseline | 48.432 score on a scale | Standard Error 1.288 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | Post-test | 50.330 score on a scale | Standard Error 1.56 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Emotional Support v.4a | Follow-up | 52.311 score on a scale | Standard Error 1.845 |
Patient-Reported Outcomes Measurement Information System Physical Function v.8b
The 8-item scale assesses for how difficult it is for one to perform daily living activities. Raw scores range from 8 to 40. T scores range from 20.3 to 60.1. Higher scores indicate better physical function and ability to perform activities of daily living.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Patient-Reported Outcomes Measurement Information System Physical Function v.8b | Baseline | 39.74 score on a scale | Standard Error 1.05 |
| GetActive | Patient-Reported Outcomes Measurement Information System Physical Function v.8b | Posttest | 42.27 score on a scale | Standard Error 1.21 |
| GetActive | Patient-Reported Outcomes Measurement Information System Physical Function v.8b | Follow-up | 44.70 score on a scale | Standard Error 1.35 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Physical Function v.8b | Baseline | 37.29 score on a scale | Standard Error 1.26 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Physical Function v.8b | Posttest | 40.18 score on a scale | Standard Error 1.37 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Physical Function v.8b | Follow-up | 41.30 score on a scale | Standard Error 1.65 |
Patient-Reported Outcomes Measurement Information System Social Isolation v.4a
The 4-item scale measures how often one perceives feeling apart from others and excluded. Raw scores range from 4 to 20. Scaled scores range from 34.8 to 74.2. Higher scores indicate greater social isolation.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | Baseline | 48.788 score on a scale | Standard Error 1.743 |
| GetActive | Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | Post-test | 45.364 score on a scale | Standard Error 1.556 |
| GetActive | Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | Follow-up | 47.582 score on a scale | Standard Error 1.673 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | Baseline | 51.880 score on a scale | Standard Error 1.538 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | Post-test | 49.793 score on a scale | Standard Error 1.629 |
| GetActive With Fitbit | Patient-Reported Outcomes Measurement Information System Social Isolation v.4a | Follow-up | 51.252 score on a scale | Standard Error 1.916 |
Physical Activity Scale for Persons With Physical Disabilities (PASIPD)
The PASIPD is a 13-item measure that assesses one's level of physical activity and exercise in the past 7 days. Scores range from 0 to 100. Higher scores indicate greater activity.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | Baseline | 9.200 score on a scale | Standard Error 1.073 |
| GetActive | Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | Posttest | 10.985 score on a scale | Standard Error 1.422 |
| GetActive | Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | Follow up | 9.097 score on a scale | Standard Error 1.28 |
| GetActive With Fitbit | Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | Baseline | 14.213 score on a scale | Standard Error 2.819 |
| GetActive With Fitbit | Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | Posttest | 16.742 score on a scale | Standard Error 2.421 |
| GetActive With Fitbit | Physical Activity Scale for Persons With Physical Disabilities (PASIPD) | Follow up | 13.396 score on a scale | Standard Error 1.791 |
Pittsburgh Sleep Quality Index (PSQI)
Measures one's sleep quality. Scores range from 0 to 21. Higher scores indicate worse sleep quality.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 8.756 score on a scale | Standard Error 0.664 |
| GetActive | Pittsburgh Sleep Quality Index (PSQI) | Post-test | 6.979 score on a scale | Standard Error 0.622 |
| GetActive | Pittsburgh Sleep Quality Index (PSQI) | Follow up | 6.565 score on a scale | Standard Error 0.558 |
| GetActive With Fitbit | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 11.293 score on a scale | Standard Error 0.629 |
| GetActive With Fitbit | Pittsburgh Sleep Quality Index (PSQI) | Post-test | 10.754 score on a scale | Standard Error 0.686 |
| GetActive With Fitbit | Pittsburgh Sleep Quality Index (PSQI) | Follow up | 10.046 score on a scale | Standard Error 0.737 |
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 of injury due to movement. Scores range from 11 to 44.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | Tampa Kinesiophobia Scale (TKS) | Baseline | 38.65 score on a scale | Standard Error 1.32 |
| GetActive | Tampa Kinesiophobia Scale (TKS) | Posttest | 31.42 score on a scale | Standard Error 1.27 |
| GetActive | Tampa Kinesiophobia Scale (TKS) | 3-Month follow- up | 35.82 score on a scale | Standard Error 1.46 |
| GetActive With Fitbit | Tampa Kinesiophobia Scale (TKS) | Baseline | 39.54 score on a scale | Standard Error 1.38 |
| GetActive With Fitbit | Tampa Kinesiophobia Scale (TKS) | Posttest | 35.22 score on a scale | Standard Error 1.32 |
| GetActive With Fitbit | Tampa Kinesiophobia Scale (TKS) | 3-Month follow- up | 35.92 score on a scale | Standard Error 1.45 |
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. Scores range from 0 to 100. Higher scores indicate more disability.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Population: We used linear mixed-models repeated measures analyses of covariance, which implicitly impute unobserved data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GetActive | WHO Disability Assessment Schedule 2.0 (WHODAS) | Baseline | 26.91 score on a scale | Standard Error 2.51 |
| GetActive | WHO Disability Assessment Schedule 2.0 (WHODAS) | Posttest | 18.56 score on a scale | Standard Error 2.28 |
| GetActive | WHO Disability Assessment Schedule 2.0 (WHODAS) | Follow-up | 20.88 score on a scale | Standard Error 3.17 |
| GetActive With Fitbit | WHO Disability Assessment Schedule 2.0 (WHODAS) | Baseline | 36.64 score on a scale | Standard Error 3.28 |
| GetActive With Fitbit | WHO Disability Assessment Schedule 2.0 (WHODAS) | Posttest | 27.88 score on a scale | Standard Error 2.71 |
| GetActive With Fitbit | WHO Disability Assessment Schedule 2.0 (WHODAS) | Follow-up | 27.42 score on a scale | Standard Error 3.38 |