NCT05373745 · ACTIVE NOT RECRUITING
Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain
This trial tests two behavioral programs called Active Brains 1 and Active Brains 2, both delivered over video, designed to help older adults who have both chronic pain and early memory or thinking concerns. The researchers want to know which program better improves physical ability, mood, and cognitive function over time. This is a Phase NA randomized controlled trial — meaning it is comparing two active approaches rather than testing a new drug for the first time.
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're excluded 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-23