[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06119698":3,"trial-entities:NCT06119698":123,"trial-summary:NCT06119698":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":41,"secondary_outcomes":46,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":77,"locations":80,"central_contacts":99,"overall_officials":103,"references":107,"see_also_links":122},"NCT06119698","2024P000782","Improving Health for Older Adults With Pain Through Engagement","Randomized, Hybrid Type 1 Effectiveness-implementation Trial of GetActive+ vs Treatment as Usual; iHOPE Study","RECRUITING","2027-07","2025-11","2025-11-18","2024-10-01","Massachusetts General Hospital","OTHER",false,"The goal of this project is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of a 10-week mind-body and walking program (GetActive+) vs treatment as usual (TAU). The investigators will test for improvements in self-reported, performance-based (i.e., six-minute walk test), and objective (i.e., step-count) physical function, emotional function, as well as feasibility, acceptability and implementation markers. Participants will complete measures at baseline (0 weeks), post-intervention (1 week after intervention completion), and 6-month follow-up.\n\nThis study will receive support from and inclusion in the HEAL Initiative (https:\u002F\u002Fheal.nih.gov\u002F).","The aim of this phase is to conduct a randomized, hybrid type 1 effectiveness-implementation trial (N=200) to evaluate the effectiveness and implementation of GetActive+ vs TAU on the following outcomes.\n\nAim 1: Self-reported physical function at 10 weeks (primary). Aim 2: Self-reported physical function at 6 months, performance based (6-minute walk test), and objective (step-count) physical function, as well as self-reported emotional function, pain, social support and loneliness at 10 weeks and 6 months.\n\nAim 3: Feasibility, acceptability, fidelity and adoption at patient, provider, and organization levels based on Proctor's implementation framework.\n\nThe investigators will enroll N=200 older adults with chronic pain from Revere HealthCare Center and MGH Broadway Primary Care in Revere. The GetActive+ program used in the Randomized Controlled Trial (RCT) will incorporate mind-body skills, cognitive behavioral and physical restoration skills (e.g., quota-based pacing) to help individuals increase self-reported, performance based and objective (step count) physical function. This program will teach participants four core skills: 1) weekly goal setting for gradual increase in time spent walking paired with activities of daily living that are meaningful and important to participants (i.e. walk instead of drive to the store; walk to the park with kids); 2) quota-based pacing (increasing walking goal gradually non-contingent of pain); 3) mind-body skills (e.g., diaphragmatic breathing to manage intense pain flares and pain anxiety; progressive muscle relaxation to increase body awareness and reduce reactivity to pain sensations; mindfulness exercises to understand the transience of pain and change one's relationship with it; self-compassion when falling short of set goals); and 4) understand the downward spiral (e.g. how reducing activity perpetuates pain and disability), correct myths about pain or unhelpful pain-related thoughts that interfere with meeting program goals. Participants will be encouraged to complete their homework (logs for mind-body practice, physical activities) each day. Participants will be given the option to receive homework and session reminders via text messages from study staff. This between-session contact will focus on increasing treatment adherence, maintaining engagement, and session reminders. The investigators will run groups primarily in English with additional groups in Spanish.\n\nBaseline assessments, post-intervention assessments and 6-month follow up assessments will include the 6MWT, objective step count via ActiGraph, and self-reported measures including physical function, emotional function, pain, social support, and loneliness while accounting for clinical, demographic, and social determinants of health.",[19,20],"Chronic Pain","Musculoskeletal Pain",[22,23,24,25,26,27],"Older adults","Mind-body intervention","Chronic pain","ActiGraph","Community health center","Physical function","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},200,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","GetActive+","This is a 10-week group mind body program focused on improving self-reported physical activity, performance-based physical activity, and ambulatory step count by combining mind body skills tailored for individuals with chronic pain, with gradual increase in walking using quota based pacing and goal setting, adapted specifically for older adults from a medically underserved location.",[38],[42],{"measure":43,"description":44,"timeFrame":45},"Physical function - self-report","Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 Physical Functioning Short Form 6b; assesses ability to carry out activities that require physical actions, ranging from self-care to work. Scores range from 6 to 30, with higher scores indicating greater physical function.","Baseline, Post-Intervention, 6-Month Follow Up (~9 months total) - Measure time point of 10 weeks is considered for primary outcome.",[47,51,54,57,60,63,66],{"measure":48,"description":49,"timeFrame":50},"Physical function - objective","Average step count with wrist-worn ActiGraph wGT3X-BT; collects average step count for 4-7 days.","Baseline, Post-Intervention, 6-Month Follow Up (~9 months total)",{"measure":52,"description":53,"timeFrame":50},"Physical function - performance-based","6-minute walk test (6MWT); measures the total distance in meters covered by an individual in 6 minutes, with greater distances covered indicating better physical function.",{"measure":55,"description":56,"timeFrame":50},"Pain Intensity and Severity","Brief Pain Inventory - Short Form (BPI-SF); assesses pain severity and interference. Scores range from 0 to 10, with higher scores indicating more severe pain severity or interference.",{"measure":58,"description":59,"timeFrame":50},"Pain Intensity and Interference","Pain, Enjoyment of Life and General Activity (PEG) Scale; measures pain intensity and pain interference in the enjoyment of life and activities of daily living. Scores range from 0 to 10, with higher scores indicating more severe pain and related interference.",{"measure":61,"description":62,"timeFrame":50},"Depression","Patient Health Questionnaire - 8 (PHQ-8); assesses depressive symptoms. Scores range from 0 to 24, with higher scores indicating more severe depressive symptoms.",{"measure":64,"description":65,"timeFrame":50},"Anxiety","Generalized Anxiety Disorder - 7 (GAD-7); measures anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety.",{"measure":67,"description":68,"timeFrame":69},"Impression of Change","Patient Global Impression of Change (PGIC); assesses subjective changes in response to the intervention. Scores range from 0 to 6, with higher scores indicating worse outcomes.","Post-Intervention","ALL","55 Years",null,{"inclusion":74,"exclusion":75,"raw_text":76},[],[],"Inclusion Criteria:\n\n1. Older Adults (i.e., age \\>=55)\n2. Diagnosed musculoskeletal chronic pain of any type (e.g., pain \\> 3 months)\n3. Pain score \\>=4 (moderate) on the Numerical Rating Scale\n4. Cognitively able to participate as measured by the Short Portable Mental Health questionnaires (e.g., \\\u003C4 errors)\n5. Self-reported ability to complete the 6-minute walk test including with assistive devices\n6. Patient at Revere HealthCare Center or MGH Broadway Primary Care in Revere who is cleared for participation by medical staff\n7. English or Spanish fluency and literacy\n\nExclusion Criteria:\n\n1. Current serious medical illness that is expected to worsen in the next 6 months (e.g., cancer)\n2. Individuals who are unwilling or unable to comply with study procedures including wearing a smartwatch\n3. Active suicidal ideation with plan or intent\n4. Active and untreated serious mental health or substance use disorder",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":13,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":96},"Boston","Massachusetts","02114","United States",[87,92],{"name":88,"role":89,"phone":90,"email":91},"Ana-Maria Vranceanu, PhD","CONTACT","617-724-4977","avranceanu@mgh.harvard.edu",{"name":93,"role":89,"phone":94,"email":95},"Christine Ritchie, MD, MPH","617-726-1382","critchie@mgh.harvard.edu",{"lat":97,"lon":98},42.35843,-71.05977,[100,101],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":102},"csritchie@mgh.harvard.edu,",[104,106],{"name":88,"affiliation":13,"role":105},"PRINCIPAL_INVESTIGATOR",{"name":93,"affiliation":13,"role":105},[108,112,115,118],{"pmid":109,"type":110,"citation":111},"33469845","BACKGROUND","Greenberg J, Lin A, Popok PJ, Kulich RJ, Edwards RR, Vranceanu AM. Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain. J Clin Psychol Med Settings. 2021 Dec;28(4):706-719. doi: 10.1007\u002Fs10880-020-09758-w. Epub 2021 Jan 19.",{"pmid":113,"type":110,"citation":114},"35914640","Grunberg VA, Greenberg J, Mace RA, Bakhshaie J, Choi KW, Vranceanu AM. Fitbit Activity, Quota-Based Pacing, and Physical and Emotional Functioning Among Adults With Chronic Pain. J Pain. 2022 Nov;23(11):1933-1944. doi: 10.1016\u002Fj.jpain.2022.07.003. Epub 2022 Jul 29.",{"pmid":116,"type":110,"citation":117},"33971485","Popok PJ, Greenberg J, Gates MV, Vranceanu AM. A qualitative investigation of activity measurement and change following a mind-body activity program for chronic pain. Complement Ther Clin Pract. 2021 Aug;44:101410. doi: 10.1016\u002Fj.ctcp.2021.101410. Epub 2021 May 2.",{"pmid":119,"type":120,"citation":121},"41326265","DERIVED","Vonderheide C, Kilduff C, McDermott KA, Greenberg J, La Camera DE, Giraldo-Santiago N, Kurkul A, Alvarez-Frank N, Kim Y, Pasinski R, Gholston M; iHOPE Study Team; Ritchie CS, Vranceanu AM. Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study. Contemp Clin Trials. 2025 Dec;159:108116. doi: 10.1016\u002Fj.cct.2025.108116. Epub 2025 Oct 24.",[],{"nct_id":4,"conditions":124,"biomarkers":125},[19,20],[],{"nct_id":4,"found":127,"summary":128,"prompt_version":137},true,{"design":129,"status":130,"heading":6,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is a randomized study comparing GetActive+ to usual care, with 200 participants planned.","completed","This study is testing a 10-week program called GetActive+ for older adults with chronic musculoskeletal pain. GetActive+ combines mind-body skills with a gradual increase in walking to help improve your physical activity and function. Researchers want to see if this program is more effective than usual care. You may be able to join if you are 55 or older, have chronic pain for at least three months, and your pain is rated as moderate or higher. The main goal is to see how your self-reported physical function changes after 10 weeks. This study is currently unclear about its recruitment status.","You will be followed for about 9 months total, with a final check-up 6 months after the intervention ends.",100,"You would participate in a 10-week program and complete measurements at the start, after the program, and 6 months later.","Not stated in the trial record.",[38],"v2"]