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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03412916
Recruitment Status : Unknown
Verified November 2019 by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Pain Chronic Pain Physical Activity Behavioral: GetActive Behavioral: Get Active with Fitbit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrating Mind Body Skills With Physical Activity to Improve Physical and Emotional Outcomes in Patients With Heterogeneous Chronic Pain
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Other Name: The Relaxation Response Resiliency Program for Pain

Experimental: 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.
Behavioral: 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.
Other Name: The Relaxation Response Resiliency Program for Pain with DMD




Primary Outcome Measures :
  1. Change in Client Satisfaction Questionnaire 3-Item (CSQ-3) [ 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.


Secondary Outcome Measures :
  1. Adherence to DMD [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks) ]
    Rate of participant's use of DMD throughout the study

  2. Adherence to Homework [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks) ]
    Rate of participant's completion of homework assigned throughout the study

  3. Therapist Adherence to Sessions [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks) ]
    Rate of interventionist's delivering the programs by following the established session topics and skills

  4. Feasibility of Quantitative Measures [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks) ]
    Rate of participant's completion of self-report measures

  5. Rescue (Non-Narcotic) Analgesic Use [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks) ]
    Single-item question on demographics form

  6. Narcotic Analgesic Use [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks) ]
    Single-item question on demographics form

  7. Adverse Events [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks) ]
    any self reported or observed negative events related to participation

  8. Credibility and Expectancy Questionnaire (CEQ) [ Time Frame: Baseline (0 Weeks) ]
    Measures how much one thinks the intervention will work

  9. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) ]
    Measures one's sleep quality

  10. PROMIS Physical Function v.8b [ 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

  11. Physical Activity Scale for Persons with Physical Disabilities (PASIPD) [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) ]
    The PASIPD measures one's level of physical activity and exercise in the past 7 days

  12. WHO Disability Assessment Schedule 2.0 (WHODAS) [ 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

  13. Numerical Rating Scale [ 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

  14. Pain Resilience Scale (PRS) [ 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

  15. PROMIS Depression v.8b [ 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

  16. PROMIS Anxiety v.8a [ 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

  17. PROMIS Social Isolation v.4a [ 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.

  18. PROMIS Emotional Support v.4a [ Time Frame: Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks) ]
    The 4-item scale measures how often one feels valued and confidant has relationships

  19. Cognitive and Affective Mindfulness Scale (CAMS) [ 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

  20. Pain Catastrophizing Scale (PCS) [ 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. A higher score indicates more catastrophizing

  21. Tampa Kinesiophobia Scale (TKS) [ 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

  22. Measure of Current Status (MOCS-A) [ 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

  23. Patient Global Impression of Change (PGIC) [ Time Frame: Post-Test (10 Weeks) ]
    The PGIC assesses clinically important change from baseline to post-test

  24. Post-Test Feasibility Questions [ Time Frame: Post-Test (10 Weeks) ]
    Assesses how helpful components of the intervention were

  25. 3-Month Follow Up Questions [ Time Frame: 3-Month Follow-Up (23 Weeks) ]
    Assesses for physical activity in the DMD group


Other Outcome Measures:
  1. Date of birth, age, gender, ethcnitiy, race, martial status, education level, employment status, type of job, income, pain diagnoses, length of chronic pain, other medical conditions, mental health conditions, pain medications, psychiatric medications [ Time Frame: Baseline (0 Weeks) ]
    This questionnaire asks individuals to report on date of birth, age, gender, ethcnitiy, race, martial status, education level, employment status, type of job, income, pain diagnoses, length of chronic pain, other medical conditions, mental health conditions, pain medications, psychiatric medications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients, age 18 years or older
  • Have nonmalignant chronic pain for more than 3 months
  • Able to perform a 6-minute walk test
  • Owns a smartphone with Bluetooth 4.0
  • Willingness and ability to participate in the 3RP intervention and to comply with the requirements of the study protocol (including weekly sessions and DMD use)
  • Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
  • Cleared by a medical doctor for study participation
  • Leads a sedentary lifestyle

Exclusion Criteria:

  • Diagnosed with medical illness expected to worsen in the next 6 months
  • Serious mental illness or instability for which hospitalization may be likely in the next 6 months
  • Current suicidal ideation reported on self-report
  • Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
  • Current substance use disorder, within the past 6 months
  • Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
  • Regular use of DMD in the last 3 months
  • Engagement in regular intensive physical exercise for >30 minute daily
  • Unable to walk without use of assistance (e.g., wheelchair, walker)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412916


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ana-Maria Vranceanu, PhD Massachusetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ana-Maria Vranceanu, PhD, Clinical Psychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03412916    
Other Study ID Numbers: 2017P000628
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana-Maria Vranceanu, PhD, Massachusetts General Hospital:
Chronic Pain
Physical Activity
Mind-body
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations