Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT05220202
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2022-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The research staff conducting outcome assessments will be blinded to whether the subject is in active or waitlist group.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This Randomized Clinical Trial will randomize to either MOTIVATE or a waitlist control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome: Pain interference', 'timeFrame': '3 months post baseline or completion of MOTIVATE', 'description': 'Pain interference will be assessed using the interference subscale of the Brief Pain Inventory (BPI) score at 3 months post-baseline or completion of MOTIVATE. Patient-reported pain-related interference (0-10 scale, with higher values indicating more pain) has been shown to be sensitive to change and to have good reliability. A mean between-group difference of 1-point in the primary outcome (change of BPI interference score from baseline to 3 months) is considered a clinically meaningful difference.'}], 'secondaryOutcomes': [{'measure': 'Depressive symptoms, PHQ-9', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'Depressive symptom severity will be assessed using the PHQ-9, a validated 9 question instrument used for monitoring and measuring the severity of depression symptoms. A cutoff score of \\>10 signifies clinically meaningful symptom burden'}, {'measure': 'Arthritis self-efficacy', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'Arthritis self-efficacy scale is a 10 point Likert scale that measures the belief or confidence the subject has to perform 8 specific activities or tasks, based on arthritis Scale range 1-10: 1) very uncertain to 10) very certain'}, {'measure': 'Pain Catastrophizing', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'Pain catastrophizing, a prominent pain behavior construct, can influence response to treatment for chronic musculoskeletal pain. Scale range 0-4: 0 (not at all) to 4 (all the time)'}, {'measure': 'Psychological resilience', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'Psychological resilience will be measured by Connor-Davidson Resilience Scale (CD-RISC). scale range 0-4: 0 (not at all) to 4 (all the time)'}, {'measure': 'Pain Behavior', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'NIH PROMIS short forms, for pain behavior have shown to have excellent psychometric properties in chronic pain. Scale range 1-6: 1 (No pain) to 6 (Always)'}, {'measure': 'Quality of Life using PROMIS Global Health Scale', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'NIH PROMIS short forms, for quality of life (PROMIS Global Health scale (physical and mental health) have shown to have excellent psychometric properties in chronic pain. Scale range 5-1: 5 (Excellent) to 1 (Poor)'}, {'measure': 'Social Functioning', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'NIH PROMIS short forms, for social functioning have shown to have excellent psychometric properties in chronic pain. Scale range 1-5: 1 (Never) to 5 (Always)'}, {'measure': 'Sleep Disturbance', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': '8-item PROMIS Sleep disturbance short form is well validated using objective sleep assessment tools (e.g., actigraphy) and used routinely in chronic pain patients and older adults. Scale range 5-1: 5 (very poor) to 1 (very good)'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'The 7-item Insomnia severity index (ISI) will assess severity of both nighttime and daytime components of insomnia scale ranges: 0 - 7 No clinically significant insomnia; 8 - 14 Subthreshold insomnia; 15 - 21 Clinical insomnia (moderate severity); 22 - 28 Clinical insomnia (severe)'}, {'measure': 'Patient Global Impression of change scale', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'Patient Global Impression of Change Scale, recommended as a core outcome measure in pain trials, will be assessed. scoring range is 1-7: 1) "no change" to 7) "a great deal better"'}, {'measure': 'FRAIL scale', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'FRAIL measures frailty among older adults. scoring consist of 5 questions: 1-2+ pre-frail; 3+ frail'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline, Mid (~5 weeks), End (~3 months) and 6 months', 'description': 'PROMIS Anxiety short forms will assess anxiety symptoms. scale range 1-5: 1 (never) to 5 (always)'}, {'measure': 'Therapeutic Alliance', 'timeFrame': 'Mid (~5 weeks), End (~3 months)', 'description': 'therapeutic alliance assessed using the Working Alliance Inventory Short-Form'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Back Pain', 'Depression', 'Veterans', 'Aging', 'Musculoskeletal Pain'], 'conditions': ['Chronic Back Pain', 'Depression', 'Aging', 'Musculoskeletal Pain']}, 'descriptionModule': {'briefSummary': 'The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.', 'detailedDescription': 'Investigators will conduct a randomized controlled trial (RCT) at two large VA facilities, to establish the effectiveness and scalability of MOTIVATE, a remotely delivered behavioral intervention for older Veterans with comorbid musculoskeletal (MSK) pain and depressive symptoms. The central hypothesis is that MOTIVATE will improve important patient-centered outcomes among older Veterans with co-occurring MSK pain and depressive symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60 and older\n* English- speaking\n* Self-reported MSK pain (include cLBP +/- radiating symptoms, OA, fibromyalgia) on most days for the past 3 months that interferes with daily activities\n* Pain intensity that is 4+/10 on the numerical pain rating scale\n* Pain interference threshold 5+ on PEG-3\n* Depressive symptoms, 10+ on PHQ-9\n* Capable of participating in home-based activity\n* Interested in participating in a non-pharmacologic program\n\nExclusion Criteria:\n\n* Aged 59 or less\n* No telephone\n* Not English speaking\n* Unwilling to be randomized to either study arm\n* Not interested in participating in a non-pharmacologic program\n* Self-reported uncorrected hearing and visual impairments precluding ability to participate in telephone sessions or read pedometer screen\n* Significant (moderate or severe) cognitive impairment (3+ errors) on six-item screening exam\n* Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe OA\\* (resulting in inability to participate in physical activity intervention)\n* Illness requiring hospitalization within the last 3 months that interferes with a home-based physical activity intervention (e.g., fall, gout attack, stroke, heart attack, heart failure, surgery for blocked arteries)\n* Suicidal intent (see suicide screening protocol), uncontrolled psychotic disorder or psychiatric hospitalization within 1 year, or enrolled in active substance use program (confirmed with scripted protocol over telephone)'}, 'identificationModule': {'nctId': 'NCT05220202', 'acronym': 'MOTIVATE_IIR', 'briefTitle': 'MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression', 'orgStudyIdInfo': {'id': 'IIR 20-256'}, 'secondaryIdInfos': [{'id': 'IRB # 1672072', 'type': 'OTHER', 'domain': 'Dallas VA Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Waitlist Control Group', 'description': 'The waitlist control group will continue with usual care management of musculoskeletal pain and depression. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the intervention once they have completed the end outcomes assessment.'}, {'type': 'EXPERIMENTAL', 'label': 'Behavior Intervention Group (MOTIVATE)', 'description': 'For participants assigned to the intervention arm, trained health coaches will deliver the 8 session intervention via telephone. MOTIVATE users motivational interviewing techniques, values elicitation and physical activity based goal setting. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant.', 'interventionNames': ['Behavioral: Behavioral Intervention Group (MOTIVATE)']}], 'interventions': [{'name': 'Behavioral Intervention Group (MOTIVATE)', 'type': 'BEHAVIORAL', 'otherNames': ['MOTIVATE'], 'description': 'Behavioral: Behavioral Intervention Group (MOTIVATE) The behavioral intervention is designed for older Veterans with musculoskeletal pain and depression and will include 8 individual telephone sessions delivered by health coaches (for up to 5 months total), accounting for additional time between sessions (if needed).', 'armGroupLabels': ['Behavior Intervention Group (MOTIVATE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216-7167', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Florine Pore-Brown, BS', 'role': 'CONTACT', 'email': 'florine.pore-brown@va.gov', 'phone': '214-857-3291'}, {'name': 'Una E. Makris, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030-4211', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thach Tran', 'role': 'CONTACT', 'email': 'thach.tran@va.gov', 'phone': '832-272-4982'}, {'name': 'Natalie E Hundt, PhD', 'role': 'CONTACT', 'email': 'Natalie.Hundt@va.gov', 'phone': '(713) 440-4450'}, {'name': 'Natalie E Hundt, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Florine Pore-Brown, BS', 'role': 'CONTACT', 'email': 'florine.pore-brown@va.gov', 'phone': '(214) 857-3291'}, {'name': 'Una E Makris, MD MSc', 'role': 'CONTACT', 'email': 'Una.Makris2@va.gov', 'phone': '(214) 857-0409'}], 'overallOfficials': [{'name': 'Una E. Makris, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Dallas VA Medical Center', 'class': 'FED'}, {'name': 'Michael E. DeBakey VA Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}