Programs to manage pain and cognitive decline in older adults

Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study

This study is testing two different online programs to see if they can help older adults with early memory problems and chronic pain feel better and improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05373745 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the efficacy of two symptom management programs, Active Brains 1 and Active Brains 2, for older adults experiencing early cognitive decline and chronic pain. Participants will engage in eight virtual sessions over Zoom, focusing on improving physical, cognitive, and emotional functions. The study will assess outcomes at baseline, post-program, and at a 6-month follow-up, while also exploring factors that may influence these outcomes. The trial aims to provide insights into how these programs can help manage symptoms and improve quality of life for participants.

Who should consider this trial

Good fit: Ideal candidates are older adults aged 60 and above with chronic pain lasting more than three months and experiencing early cognitive decline.

Not a fit: Patients with diagnosed dementia or those currently on psychotropic or pain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management of chronic pain and cognitive decline in older adults, leading to improved overall well-being.

How similar studies have performed: Other studies have shown promise in using virtual interventions for managing chronic pain and cognitive issues, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Ana-Maria Vranceanu, PhD — Massachusetts General Hospital
• Study coordinator: Ana-Maria Vranceanu, PhD

Conditions: Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity, Memory Related Problems, Early Cognitive Decline