Clinical trial NCT05373745: Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain
Official title: Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Mild Cognitive Impairment
Older Adults
Physical Activity
Keywords: Chronic Pain
Mild Cognitive Impairment
Older Adults
Physical Activity
Memory Related Problems
Early Cognitive Decline
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 260
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Change in PROMIS Physical Function
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Change in six-minute walk test (6MWT)
timeFrame: 0 Weeks, 8 Weeks, 6 Months
Secondary outcomes:
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Everyday Cognition Scale (eCog-12)
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: PROMIS Depression
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: PROMIS Anxiety
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Numerical Rating Scale
timeFrame: 0 Weeks, 8 Weeks, 6 Months
Other outcomes:
measure: Change in PROMIS Pain Interference - Short Form 6b V1.0
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Pain Catastrophizing Scale
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Tampa Kinesiophobia Scale
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Pain Self-Efficacy
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Self-Compassion Scale
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Measure of Current Status
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Gratitude Questionnaire
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Toronto Mindfulness Scale
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: NIH Toolbox Item Bank v2.0 - Loneliness (Ages 18+) - Fixed Form
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: PROMIS Satisfaction with Social Roles and Activities
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Memory Compensation Questionnaire
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: The Pain, Enjoyment of Life and General Activity (PEG) Scale
timeFrame: 1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks
measure: Global Cognitive and Social Engagement
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Quota-Based Pacing
timeFrame: 0 Weeks, 8 Weeks, 6 Months
measure: Pain Interference Weekly Measure
timeFrame: 1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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. 2022 Aug 12;62(7):1082-1094. doi: 10.1093/geront/gnab135.