Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain

Completed · Not applicable

Conditions studied: Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity

In brief

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-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how each program may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors. Both programs will be delivered virtually (Zoom).

Key facts

Study ID

NCT05373745

Run by

Massachusetts General Hospital

People needed

267

Starts

2022-06-20

Expected to finish

2026-06-01

Last updated by the study team

2026-06-12

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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