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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03412916
• Other study ID #: 2017P000628
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Chronic Pain
• Pain
• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	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	Baseline (0 Weeks)
Primary	Change in Client Satisfaction Questionnaire 3-Item (CSQ-3)	Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction.	Post-Test (10 Weeks)
Secondary	Adherence to DMD	Rate of participant's use of DMD throughout the study	Baseline (0 Weeks), Post-Test (10 Weeks)
Secondary	Adherence to Homework	Rate of participant's completion of homework assigned throughout the study	Baseline (0 Weeks), Post-Test (10 Weeks)
Secondary	Therapist Adherence to Sessions	Rate of interventionist's delivering the programs by following the established session topics and skills	Baseline (0 Weeks), Post-Test (10 Weeks)
Secondary	Feasibility of Quantitative Measures	Rate of participant's completion of self-report measures	Baseline (0 Weeks), Post-Test (10 Weeks)
Secondary	Rescue (Non-Narcotic) Analgesic Use	Single-item question on demographics form	Baseline (0 Weeks), Post-Test (10 Weeks)
Secondary	Narcotic Analgesic Use	Single-item question on demographics form	Baseline (0 Weeks), Post-Test (10 Weeks)
Secondary	Adverse Events	any self reported or observed negative events related to participation	Baseline (0 Weeks), Post-Test (10 Weeks)
Secondary	Credibility and Expectancy Questionnaire (CEQ)	Measures how much one thinks the intervention will work	Baseline (0 Weeks)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Measures one's sleep quality	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	PROMIS Physical Function v.8b	The 8-item scale assesses for how difficult it is for one to perform daily living activities	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	Physical Activity Scale for Persons with Physical Disabilities (PASIPD)	The PASIPD measures one's level of physical activity and exercise in the past 7 days	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
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	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
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	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
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	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	PROMIS Depression v.8b	The 8-item scale measures depressive symptoms over the past week	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	PROMIS Anxiety v.8a	The 8-item scale measures fear and worry over the past week	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	PROMIS Social Isolation v.4a	The 4-item scale measures how often one perceives feeling apart from others and excluded.	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	PROMIS Emotional Support v.4a	The 4-item scale measures how often one feels valued and confidant has relationships	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	Cognitive and Affective Mindfulness Scale (CAMS)	The CAMS, a 12-item scale, measures how much one experiences their thoughts and feelings	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	Pain Catastrophizing Scale (PCS)	The PCS, a 13-item scale, measures how individuals experience pain, in terms of catastrophizing. A higher score indicates more catastrophizing	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
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	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
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	Baseline (0 Weeks), Post-Test (10 Weeks), 3-Month Follow-Up (23 Weeks)
Secondary	Patient Global Impression of Change (PGIC)	The PGIC assesses clinically important change from baseline to post-test	Post-Test (10 Weeks)
Secondary	Post-Test Feasibility Questions	Assesses how helpful components of the intervention were	Post-Test (10 Weeks)
Secondary	3-Month Follow Up Questions	Assesses for physical activity in the DMD group	3-Month Follow-Up (23 Weeks)