NCT05373745

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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-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).

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-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how the two programs may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes 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, and type of early cognitive decline. Both programs will be delivered virtually (Zoom). Each group meets for eight, 90 minutes sessions over the secure Zoom platform. Each group has 5-8 participants. Participants receive a treatment manual. There are 3 assessment points: baseline, post program and 6-month follow-up. Assessments involve self-report questionnaires, a walk test and a neuropsychological evaluation.

Conditions

• Chronic Pain
• Mild Cognitive Impairment
• Older Adults
• Physical Activity

Interventions

Type	Name	Description
BEHAVIORAL	Active Brains 1	Active Brains 1 uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions and weekly practice assignments (homework). The Active Brains sessions teach skills and strategies to manage early cognitive concerns and chronic pain. The format is an 8-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. Active Brains 1 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
BEHAVIORAL	Active Brains 2	This active comparison condition controls for the effect of time spent, group member support/feedback and interventionist support/feedback. Active Brains 2 addresses population-specific challenges of chronic pain and early cognitive decline symptoms. Participants also receive lifestyle education consistent from public health recommendations and standards for health promotion (e.g., "Sleep", "Nutrition", "Healthy Weight" and "Medical appointments". The Active Brains 2 program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The Active Brains 2 is conducted in the same format as Active Brains 1, but participants are not taught the mind-body, walking or cognitive-behavioral skills. Active Brains 2 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

Timeline

• Start date: 2022-06-20
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2022-05-13
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States