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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03412916
Enrollment
82
Registered
2018-01-29
Start date
2017-10-01
Completion date
2020-06-30
Last updated
2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Pain, Physical Activity

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

BEHAVIORALGetActive

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.

BEHAVIORALGet 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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Percentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale MidpointPost-Test (10 Weeks)Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Therapist AdherenceCollected during the interventionTwo 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 DaysBaseline (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 ParticipationBaseline (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 CriteriaBaseline (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 MeasuresBaseline (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 AcceptabilityPost-Test (10 Weeks)Assessed via the percentage of participants who attended at least 7 out of 10 sessions.

Secondary

MeasureTime frameDescription
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 ScaleBaseline (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 Distance6 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.4aBaseline (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.4aBaseline (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 Steps1 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.8bBaseline (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.8aBaseline (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.8bBaseline (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

ArmCount
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
Total82

Baseline characteristics

CharacteristicGetActiveGetActive With FitbitTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants7 Participants16 Participants
Age, Categorical
Between 18 and 65 years
32 Participants34 Participants66 Participants
Age, Continuous54.46 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 Participants8 Participants17 Participants
Education
Graduate/professional degree (>16 years)
12 Participants16 Participants28 Participants
Education
High school (12 years)
5 Participants6 Participants11 Participants
Education
Some college/associate degree (<16 years)
15 Participants11 Participants26 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants4 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
35 Participants37 Participants72 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants2 Participants
Marital status
Living with significant other
5 Participants6 Participants11 Participants
Marital status
Married
15 Participants8 Participants23 Participants
Marital status
Separated/divorced
5 Participants11 Participants16 Participants
Marital status
Single, never married
13 Participants15 Participants28 Participants
Marital status
Widowed
3 Participants1 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Black or African American
5 Participants2 Participants7 Participants
Race (NIH/OMB)
More than one race
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
32 Participants34 Participants66 Participants
Sex: Female, Male
Female
23 Participants31 Participants54 Participants
Sex: Female, Male
Male
18 Participants10 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 37
other
Total, other adverse events
3 / 357 / 37
serious
Total, serious adverse events
1 / 351 / 37

Outcome results

Primary

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
GetActiveAdherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 DaysBaselineWho received the ActiGraph and wore it for ≥ 5 out of 7 days31 Participants
GetActiveAdherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 DaysBaselineWho received the ActiGraph and wore it for < 5 out of 7 days2 Participants
GetActiveAdherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 DaysPost-TestWho received the ActiGraph and wore it for ≥ 5 out of 7 days25 Participants
GetActiveAdherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 DaysPost-TestWho received the ActiGraph and wore it for < 5 out of 7 days2 Participants
GetActive With FitbitAdherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 DaysPost-TestWho received the ActiGraph and wore it for < 5 out of 7 days4 Participants
GetActive With FitbitAdherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 DaysBaselineWho received the ActiGraph and wore it for ≥ 5 out of 7 days36 Participants
GetActive With FitbitAdherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 DaysPost-TestWho received the ActiGraph and wore it for ≥ 5 out of 7 days29 Participants
GetActive With FitbitAdherence to DMD - Number of Participants Who Wore DMD for ≥ 5 and < 5 Out of 7 DaysBaselineWho received the ActiGraph and wore it for < 5 out of 7 days3 Participants
Primary

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)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
GetActiveAdherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteriaparticipants that completed logs handed in met adherence criteria34 Participants
GetActiveAdherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteriaparticipants that completed logs handed in that did not meet adherence criteria1 Participants
GetActive With FitbitAdherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteriaparticipants that completed logs handed in met adherence criteria36 Participants
GetActive With FitbitAdherence to Home Practice - Number of Participants That Completed Homework Logs That Met Adherence Criteriaparticipants that completed logs handed in that did not meet adherence criteria1 Participants
Primary

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)

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
GetActiveCredibility and Expectancy Questionnaire (CEQ)Expectancyscored above the scale midpoint27 Participants
GetActiveCredibility and Expectancy Questionnaire (CEQ)Expectancyscored below the scale midpoint14 Participants
GetActiveCredibility and Expectancy Questionnaire (CEQ)Credibilityscored above the scale midpoint37 Participants
GetActiveCredibility and Expectancy Questionnaire (CEQ)Credibilityscored below the scale midpoint4 Participants
GetActive With FitbitCredibility and Expectancy Questionnaire (CEQ)Credibilityscored below the scale midpoint3 Participants
GetActive With FitbitCredibility and Expectancy Questionnaire (CEQ)Expectancyscored above the scale midpoint22 Participants
GetActive With FitbitCredibility and Expectancy Questionnaire (CEQ)Credibilityscored above the scale midpoint38 Participants
GetActive With FitbitCredibility and Expectancy Questionnaire (CEQ)Expectancyscored below the scale midpoint19 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GetActiveFeasibility of Quantitative Measures41 Participants
GetActive With FitbitFeasibility of Quantitative Measures40 Participants
Primary

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)

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
GetActivePercentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale MidpointScored above the scale midpoint34 Participants
GetActivePercentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale MidpointScored below the scale midpoint0 Participants
GetActive With FitbitPercentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale MidpointScored above the scale midpoint35 Participants
GetActive With FitbitPercentage of Participants With Client Satisfaction Questionnaire 3-Item (CSQ-3) Scores Above and Below the Scale MidpointScored below the scale midpoint1 Participants
Primary

Program Acceptability

Assessed via the percentage of participants who attended at least 7 out of 10 sessions.

Time frame: Post-Test (10 Weeks)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
GetActiveProgram AcceptabilityAttended ≥7 out of 10 group or make-up sessions31 Participants
GetActiveProgram AcceptabilityAttended <7 out of 10 group or make-up sessions10 Participants
GetActive With FitbitProgram AcceptabilityAttended ≥7 out of 10 group or make-up sessions34 Participants
GetActive With FitbitProgram AcceptabilityAttended <7 out of 10 group or make-up sessions7 Participants
Primary

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)

ArmMeasureValue (NUMBER)
GetActiveProgram Safety - Number of Adverse Events Related to Study Participation0 adverse events
GetActive With FitbitProgram Safety - Number of Adverse Events Related to Study Participation0 adverse events
Primary

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

ArmMeasureValue (NUMBER)
GetActiveTherapist Adherence94 percentage of adherence
GetActive With FitbitTherapist Adherence98 percentage of adherence
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActive6-Min Walk Test DistanceBaseline346.244 MetersStandard Error 13.684
GetActive6-Min Walk Test DistancePosttest389.492 MetersStandard Error 12.95
GetActive With Fitbit6-Min Walk Test DistanceBaseline331.866 MetersStandard Error 13.898
GetActive With Fitbit6-Min Walk Test DistancePosttest385.872 MetersStandard Error 12.691
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActiveActiGraph Average StepsBaseline5621.095674 StepsStandard Error 595.369
GetActiveActiGraph Average StepsPosttest5606.226 StepsStandard Error 600.898
GetActive With FitbitActiGraph Average StepsBaseline5226.732 StepsStandard Error 409.875
GetActive With FitbitActiGraph Average StepsPosttest5271.760 StepsStandard Error 391.723
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActiveCognitive and Affective Mindfulness Scale (CAMS)Baseline Mindfulness32.12 score on a scaleStandard Error 0.99
GetActiveCognitive and Affective Mindfulness Scale (CAMS)Posttest Mindfulness36.09 score on a scaleStandard Error 1.07
GetActiveCognitive and Affective Mindfulness Scale (CAMS)Three-Month follow-up Mindfulness35.95 score on a scaleStandard Error 1.09
GetActive With FitbitCognitive and Affective Mindfulness Scale (CAMS)Baseline Mindfulness30.29 score on a scaleStandard Error 1.11
GetActive With FitbitCognitive and Affective Mindfulness Scale (CAMS)Posttest Mindfulness33.07 score on a scaleStandard Error 1
GetActive With FitbitCognitive and Affective Mindfulness Scale (CAMS)Three-Month follow-up Mindfulness34.08 score on a scaleStandard Error 1.36
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActiveMeasure of Current Status (MOCS-A)Baseline Adaptive Coping27.56 score on a scaleStandard Error 1.49
GetActiveMeasure of Current Status (MOCS-A)Posttest Adaptive Coping36.09 score on a scaleStandard Error 1.43
GetActiveMeasure of Current Status (MOCS-A)Three-Month follow-up Adaptive Coping34.24 score on a scaleStandard Error 1.5
GetActive With FitbitMeasure of Current Status (MOCS-A)Baseline Adaptive Coping27.27 score on a scaleStandard Error 1.5
GetActive With FitbitMeasure of Current Status (MOCS-A)Posttest Adaptive Coping34.10 score on a scaleStandard Error 1.33
GetActive With FitbitMeasure of Current Status (MOCS-A)Three-Month follow-up Adaptive Coping31.98 score on a scaleStandard Error 1.36
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActiveNumerical Rating ScaleBaseline Pain at rest5.07 score on a scaleStandard Error 0.39
GetActiveNumerical Rating ScalePosttest Pain at rest3.73 score on a scaleStandard Error 0.41
GetActiveNumerical Rating ScaleFollow up Pain at rest4.18 score on a scaleStandard Error 0.41
GetActiveNumerical Rating ScaleBaseline Pain during activity6.93 score on a scaleStandard Error 0.31
GetActiveNumerical Rating ScalePosttest Pain during activity5.16 score on a scaleStandard Error 0.42
GetActiveNumerical Rating ScaleFollow-up Pain during activity5.28 score on a scaleStandard Error 0.45
GetActive With FitbitNumerical Rating ScalePosttest Pain during activity6.01 score on a scaleStandard Error 0.41
GetActive With FitbitNumerical Rating ScaleBaseline Pain at rest5.70 score on a scaleStandard Error 0.34
GetActive With FitbitNumerical Rating ScaleBaseline Pain during activity7.15 score on a scaleStandard Error 0.34
GetActive With FitbitNumerical Rating ScalePosttest Pain at rest4.58 score on a scaleStandard Error 0.36
GetActive With FitbitNumerical Rating ScaleFollow-up Pain during activity5.31 score on a scaleStandard Error 0.6
GetActive With FitbitNumerical Rating ScaleFollow up Pain at rest4.30 score on a scaleStandard Error 0.5
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePain Catastrophizing Scale (PCS)Baseline19.71 score on a scaleStandard Error 1.84
GetActivePain Catastrophizing Scale (PCS)Posttest9.98 score on a scaleStandard Error 1.29
GetActivePain Catastrophizing Scale (PCS)Three-Month follow-up9.91 score on a scaleStandard Error 1.49
GetActive With FitbitPain Catastrophizing Scale (PCS)Baseline22.27 score on a scaleStandard Error 1.89
GetActive With FitbitPain Catastrophizing Scale (PCS)Posttest16.75 score on a scaleStandard Error 1.77
GetActive With FitbitPain Catastrophizing Scale (PCS)Three-Month follow-up16.79 score on a scaleStandard Error 2.03
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePain Resilience Scale (PRS)Baseline Pain resilience37.68 score on a scaleStandard Error 1.47
GetActivePain Resilience Scale (PRS)Posttest Pain resilience43.55 score on a scaleStandard Error 1.64
GetActivePain Resilience Scale (PRS)3-Month follow- up Pain resilience45.02 score on a scaleStandard Error 1.39
GetActive With FitbitPain Resilience Scale (PRS)Baseline Pain resilience32.51 score on a scaleStandard Error 1.58
GetActive With FitbitPain Resilience Scale (PRS)Posttest Pain resilience36.19 score on a scaleStandard Error 1.82
GetActive With FitbitPain Resilience Scale (PRS)3-Month follow- up Pain resilience36.13 score on a scaleStandard Error 2.07
Secondary

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)

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePatient Global Impression of Change (PGIC)Impression of change in pain2.51 score on a scaleStandard Deviation 1.17
GetActivePatient Global Impression of Change (PGIC)Impression of change in physical activity2.31 score on a scaleStandard Deviation 1.18
GetActivePatient Global Impression of Change (PGIC)Impression of change in physical function2.57 score on a scaleStandard Deviation 1.19
GetActivePatient Global Impression of Change (PGIC)Impression of change in emotional function2.40 score on a scaleStandard Deviation 1.01
GetActivePatient Global Impression of Change (PGIC)Impression of change in resiliency2.14 score on a scaleStandard Deviation 0.91
GetActivePatient Global Impression of Change (PGIC)Impression of change from use of FitbitNA score on a scale
GetActive With FitbitPatient Global Impression of Change (PGIC)Impression of change in resiliency2.32 score on a scaleStandard Deviation 1.03
GetActive With FitbitPatient Global Impression of Change (PGIC)Impression of change in pain2.70 score on a scaleStandard Deviation 1.2
GetActive With FitbitPatient Global Impression of Change (PGIC)Impression of change in emotional function2.54 score on a scaleStandard Deviation 0.84
GetActive With FitbitPatient Global Impression of Change (PGIC)Impression of change in physical activity2.30 score on a scaleStandard Deviation 1.1
GetActive With FitbitPatient Global Impression of Change (PGIC)Impression of change from use of Fitbit1.86 score on a scaleStandard Deviation 0.95
GetActive With FitbitPatient Global Impression of Change (PGIC)Impression of change in physical function2.78 score on a scaleStandard Deviation 0.95
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePatient-Reported Outcomes Measurement Information System Anxiety v.8aBaseline53.50 score on a scaleStandard Deviation 1.58
GetActivePatient-Reported Outcomes Measurement Information System Anxiety v.8aPosttest51.26 score on a scaleStandard Deviation 1.41
GetActivePatient-Reported Outcomes Measurement Information System Anxiety v.8aFollow-up51.49 score on a scaleStandard Deviation 1.68
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Anxiety v.8aBaseline59.33 score on a scaleStandard Deviation 1.39
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Anxiety v.8aPosttest56.39 score on a scaleStandard Deviation 1.53
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Anxiety v.8aFollow-up57.27 score on a scaleStandard Deviation 1.62
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePatient-Reported Outcomes Measurement Information System Depression v.8bBaseline53.14 score on a scaleStandard Error 1.69
GetActivePatient-Reported Outcomes Measurement Information System Depression v.8bPosttest50.21 score on a scaleStandard Error 1.55
GetActivePatient-Reported Outcomes Measurement Information System Depression v.8bFollow-up50.21 score on a scaleStandard Error 1.54
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Depression v.8bBaseline60.02 score on a scaleStandard Error 1.45
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Depression v.8bPosttest55.74 score on a scaleStandard Error 1.21
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Depression v.8bFollow-up55.75 score on a scaleStandard Error 1.7
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePatient-Reported Outcomes Measurement Information System Emotional Support v.4aBaseline49.924 score on a scaleStandard Error 1.365
GetActivePatient-Reported Outcomes Measurement Information System Emotional Support v.4aPost-test53.078 score on a scaleStandard Error 1.604
GetActivePatient-Reported Outcomes Measurement Information System Emotional Support v.4aFollow-up53.425 score on a scaleStandard Error 1.417
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Emotional Support v.4aBaseline48.432 score on a scaleStandard Error 1.288
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Emotional Support v.4aPost-test50.330 score on a scaleStandard Error 1.56
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Emotional Support v.4aFollow-up52.311 score on a scaleStandard Error 1.845
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePatient-Reported Outcomes Measurement Information System Physical Function v.8bBaseline39.74 score on a scaleStandard Error 1.05
GetActivePatient-Reported Outcomes Measurement Information System Physical Function v.8bPosttest42.27 score on a scaleStandard Error 1.21
GetActivePatient-Reported Outcomes Measurement Information System Physical Function v.8bFollow-up44.70 score on a scaleStandard Error 1.35
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Physical Function v.8bBaseline37.29 score on a scaleStandard Error 1.26
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Physical Function v.8bPosttest40.18 score on a scaleStandard Error 1.37
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Physical Function v.8bFollow-up41.30 score on a scaleStandard Error 1.65
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePatient-Reported Outcomes Measurement Information System Social Isolation v.4aBaseline48.788 score on a scaleStandard Error 1.743
GetActivePatient-Reported Outcomes Measurement Information System Social Isolation v.4aPost-test45.364 score on a scaleStandard Error 1.556
GetActivePatient-Reported Outcomes Measurement Information System Social Isolation v.4aFollow-up47.582 score on a scaleStandard Error 1.673
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Social Isolation v.4aBaseline51.880 score on a scaleStandard Error 1.538
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Social Isolation v.4aPost-test49.793 score on a scaleStandard Error 1.629
GetActive With FitbitPatient-Reported Outcomes Measurement Information System Social Isolation v.4aFollow-up51.252 score on a scaleStandard Error 1.916
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePhysical Activity Scale for Persons With Physical Disabilities (PASIPD)Baseline9.200 score on a scaleStandard Error 1.073
GetActivePhysical Activity Scale for Persons With Physical Disabilities (PASIPD)Posttest10.985 score on a scaleStandard Error 1.422
GetActivePhysical Activity Scale for Persons With Physical Disabilities (PASIPD)Follow up9.097 score on a scaleStandard Error 1.28
GetActive With FitbitPhysical Activity Scale for Persons With Physical Disabilities (PASIPD)Baseline14.213 score on a scaleStandard Error 2.819
GetActive With FitbitPhysical Activity Scale for Persons With Physical Disabilities (PASIPD)Posttest16.742 score on a scaleStandard Error 2.421
GetActive With FitbitPhysical Activity Scale for Persons With Physical Disabilities (PASIPD)Follow up13.396 score on a scaleStandard Error 1.791
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActivePittsburgh Sleep Quality Index (PSQI)Baseline8.756 score on a scaleStandard Error 0.664
GetActivePittsburgh Sleep Quality Index (PSQI)Post-test6.979 score on a scaleStandard Error 0.622
GetActivePittsburgh Sleep Quality Index (PSQI)Follow up6.565 score on a scaleStandard Error 0.558
GetActive With FitbitPittsburgh Sleep Quality Index (PSQI)Baseline11.293 score on a scaleStandard Error 0.629
GetActive With FitbitPittsburgh Sleep Quality Index (PSQI)Post-test10.754 score on a scaleStandard Error 0.686
GetActive With FitbitPittsburgh Sleep Quality Index (PSQI)Follow up10.046 score on a scaleStandard Error 0.737
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActiveTampa Kinesiophobia Scale (TKS)Baseline38.65 score on a scaleStandard Error 1.32
GetActiveTampa Kinesiophobia Scale (TKS)Posttest31.42 score on a scaleStandard Error 1.27
GetActiveTampa Kinesiophobia Scale (TKS)3-Month follow- up35.82 score on a scaleStandard Error 1.46
GetActive With FitbitTampa Kinesiophobia Scale (TKS)Baseline39.54 score on a scaleStandard Error 1.38
GetActive With FitbitTampa Kinesiophobia Scale (TKS)Posttest35.22 score on a scaleStandard Error 1.32
GetActive With FitbitTampa Kinesiophobia Scale (TKS)3-Month follow- up35.92 score on a scaleStandard Error 1.45
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
GetActiveWHO Disability Assessment Schedule 2.0 (WHODAS)Baseline26.91 score on a scaleStandard Error 2.51
GetActiveWHO Disability Assessment Schedule 2.0 (WHODAS)Posttest18.56 score on a scaleStandard Error 2.28
GetActiveWHO Disability Assessment Schedule 2.0 (WHODAS)Follow-up20.88 score on a scaleStandard Error 3.17
GetActive With FitbitWHO Disability Assessment Schedule 2.0 (WHODAS)Baseline36.64 score on a scaleStandard Error 3.28
GetActive With FitbitWHO Disability Assessment Schedule 2.0 (WHODAS)Posttest27.88 score on a scaleStandard Error 2.71
GetActive With FitbitWHO Disability Assessment Schedule 2.0 (WHODAS)Follow-up27.42 score on a scaleStandard Error 3.38

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026