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

Overview

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).

Full Title of Study: “Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2025

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in PROMIS Physical Function
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Change in rate of a participant’s capability rather than performance of physical activities, with items ranging from 1-4, and total scores ranging from 8-40, with a higher score reflecting greater physical function
  • Change in PROMIS Pain Interference – Short Form 6b V1.0
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Change in the self-reported consequences of pain on relevant aspects of a person’s life.
  • Change in Step Count via the ActiGraph GT3XP-BTLE Accelerometer
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Measures the change in activity during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up. Assess number of steps, as well as minutes of activity (light, moderate, vigorous and minutes of sedentary time).
  • Change in six-minute walk test (6MWT)
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Assesses changes distance walked in 6 minutes.

Secondary Measures

  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • A comprehensive assessment that includes measures of memory, executive functioning, cognitive flexibility, attention, (etc.) and provides a measure of global cognition.
  • Montreal Cognitive Assessment (MoCA; audiovisual version)
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Assesses several cognitive domains and detection of mild cognitive impairment (MCI), with scores ranging from 0-30 and lower scores indicating greater cognitive decline.
  • Everyday Cognition Scale (eCog-12)
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of participant’s cognitively mediated functional abilities, with items ranging from 1-5, with a total score ranging from 12-60, with higher scores indicating greater cognitive decline.
  • PROMIS Depression
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s negative mood, social cognition and views of self, with items ranging from 1-5, total scores ranging from 8-40, and a higher score reflecting higher levels of depression.
  • PROMIS Anxiety
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s fear, anxious, hyper arousal and somatic symptoms pertaining to arousal, with items ranging from 1-5, total scores ranging from 8-40, and a high score reflecting higher levels of anxiety.
  • Numerical Rating Scale
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s pain at rest and with activity using a Likert scale with 0 being no pain and 10 being worst possible pain.
  • Pain Catastrophizing Scale
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • 10. Pain Catastrophizing Scale
  • Tampa Kinesiophobia Scale
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s fear of movement, with items ranging from 1-4, and total scores ranging from 17 to 68, and higher scores indicating higher levels of fear of movement
  • Pain Self-Efficacy
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s confidence to do various activities despite their pain, with items ranging from 0-6, and a higher score showing greater levels of confidence with pain self-efficacy, with total scores ranging from 0-60
  • Self-Compassion Scale
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s amount of self-compassion, with items ranging from 1-5, and total scores ranging from 12-60 and higher scores indicating higher levels of self-compassion
  • Measure of Current Status
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s self-reported perceived stress self-management skills, with items ranging from 0-4 and a total score ranging from 0-52, and higher scores reflecting more usage of stress self-management skills
  • Gratitude Questionnaire
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s proneness to experience gratitude in daily life, with items ranging from 1-7, total scores ranging from 6-24, and a higher score indicating greater amount of gratitude
  • Toronto Mindfulness Scale
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s state mindfulness in the moment, with items ranging from 1-5, total scores ranging from 13-65, and a higher score indicating a greater amount of state-level mindfulness.
  • PROMIS Loneliness
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Measure of an individual’s perceptions that one is alone, lonely, or socially isolated from others, with items ranging from 1-5, total scores ranging from 4-20, and a higher score indicating a greater degree of loneliness.
  • PROMIS Emotional Support
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s perceived feelings of being cared and values for as an individual, with items ranging from 1-5, total scores ranging from 4-20, and a higher score indicating higher perceived social support
  • Memory Compensation Questionnaire
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s use of cognitive compensatory strategies for actual or perceived memory loss, items range from 0-4, total scores range from 0-52 with a higher score reflecting greater use of compensatory strategies.
  • Interpersonal Support Evaluation List
    • Time Frame: 0 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s perceived social support on three dimensions: appraisal of support, belonging support, and tangible support. Items range from 1-4, and total scores range from 12-48, with higher scores indicating greater levels of perceived support.
  • The Pain, Enjoyment of Life and General Activity (PEG) Scale
    • Time Frame: 0 Weeks, 1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks, 8 Weeks, 6 Months
    • Rate of a participant’s chronic pain level, measured by pain intensity and pain interference. Items range from 0-10, and total scores range from 0-30, with higher scores indicating greater levels of chronic pain.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ana-Maria Vranceanu, PhD, Associate Professor/Director – Massachusetts General Hospital
  • Overall Official(s)
    • Ana-Maria Vranceanu, PhD, Principal Investigator, Massachusetts General Hospital
  • Overall Contact(s)
    • Ana-Maria Vranceanu, PhD, 6176437996, avranceanu@mgh.harvard.edu

References

Mace RA, Doorley JD, Popok PJ, Vranceanu AM. Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study. JMIR Res Protoc. 2021 Jan 4;10(1):e25351. doi: 10.2196/25351.

Mace RA, Gates MV, Popok PJ, Kulich R, Quiroz YT, Vranceanu AM. Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Nov 15;61(8):1326-1337. doi: 10.1093/geront/gnaa179.

Mace RA, Gates MV, Bullard B, Lester EG, Silverman IH, Quiroz YT, Vranceanu AM. Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Apr 3;61(3):449-459. doi: 10.1093/geront/gnaa084.

Doorley JD, Mace RA, Popok PJ, Grunberg VA, Ragnhildstveit A, Vranceanu AM. Feasibility randomized controlled trial of a mind-body activity program for older adults with chronic pain and cognitive decline: The virtual "Active Brains" study. Gerontologist. 2021 Sep 6. pii: gnab135. doi: 10.1093/geront/gnab135. [Epub ahead of print]

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