Programs to manage pain and cognitive decline in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: avranceanu@mgh.harvard.edu
• Phone: 6176437996

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.