Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT03412916
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
Other names: The Relaxation Response Resiliency Program for Pain
The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
Other names: The Relaxation Response Resiliency Program for Pain with DMD
Time frame: Post-Test (10 Weeks)
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (0 Weeks), Post-Test (10 Weeks)
Any self-reported or observed negative events related to participation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-Test (10 Weeks)
Assessed via the percentage of participants who attended at least 7 out of 10 sessions.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Massachusetts General Hospital
Other
Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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