Status:
ACTIVE_NOT_RECRUITING
Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Chronic Pain
Mild Cognitive Impairment
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The investigators aim to conduct a fully powered randomized controlled trial to compare the efficacy of two symptom management programs for older adults with early cognitive decline (either self-repor...
Detailed Description
The investigators aim to conduct a fully powered randomized controlled trial to establish efficacy of two symptom management programs for older adults with early cognitive decline (either self-reporte...
Eligibility Criteria
Inclusion
- Male and female outpatients, age 60 years or older
- Have nonmalignant chronic pain for more than 3 months
- Reports early cognitive decline (subjective or objective)
- Telephone Interview for Cognitive Status-30 score greater than or equal to 17
- Functional Activities Questionnaire score less than 9
- Able to perform a 6-minute walk test at an accelerated pace
- English fluency/literacy
- Willingness and ability to participate and use an ActiGraph watch and smartphone app to view and sync the step count and sleep data
- 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 and no self-reported concerns about physical functioning on the revised Physical Activity Readiness Questionnaire (PAR-Q; score 0)
Exclusion
- Diagnosed with dementia or neurodegenerative disease
- Diagnosed with medical illness expected to worsen in the next 6 months
- Diagnosed with serious untreated mental illness (i.e., schizophrenia) or untreated substance use disorder
- Current suicidal ideation reported on self-report
- Engaging in regular mindfulness practice \> 45 min/week or has completed a course of cognitive behavioral therapy in the past 3 months
- Regular use of a digital-monitoring device
- Engagement in regular intensive physical exercise for \>30 minute daily
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT05373745
Start Date
June 20 2022
End Date
December 31 2026
Last Update
November 24 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114