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

NCT05373745 | Active Not Recruiting DMC

• 1 other identifier: 2021P00281
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (3)

• Change in PROMIS Physical Function

  Change in rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4. Higher T scores indicate greater physical function.

  0 Weeks, 8 Weeks, 6 Months

• Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer

  Measures the change in steps during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up.

  0 Weeks, 8 Weeks, 6 Months

• Change in six-minute walk test (6MWT)

  Assesses distance walked in 6 minutes.

  0 Weeks, 8 Weeks, 6 Months

Secondary Outcomes (5)

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  0 Weeks, 8 Weeks, 6 Months

• Everyday Cognition Scale (eCog-12)

  0 Weeks, 8 Weeks, 6 Months

• PROMIS Depression

  0 Weeks, 8 Weeks, 6 Months

• PROMIS Anxiety

  0 Weeks, 8 Weeks, 6 Months

• Numerical Rating Scale

  0 Weeks, 8 Weeks, 6 Months

Other Outcomes (15)

• Change in PROMIS Pain Interference - Short Form 6b V1.0

  0 Weeks, 8 Weeks, 6 Months

• Pain Catastrophizing Scale

  0 Weeks, 8 Weeks, 6 Months

• Tampa Kinesiophobia Scale

  0 Weeks, 8 Weeks, 6 Months

Study Arms (2)

Active Brains 1

EXPERIMENTAL

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 1

Active Brains 2

PLACEBO COMPARATOR

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.

Behavioral: Active Brains 2

Interventions

Active Brains 1 BEHAVIORAL

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.

Active Brains 1

Active Brains 2 BEHAVIORAL

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.

Active Brains 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

• 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.

  PMID: 33208301 BACKGROUND

• 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.

  PMID: 33159516 BACKGROUND

• 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.

  PMID: 32601670 BACKGROUND

• 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.

  PMID: 34487167 BACKGROUND

• Vranceanu AM, Choukas NR, Rochon EA, Duarte B, Pietrzykowski MO, McDermott K, Hooker JE, Kulich R, Quiroz YT, Parker RA, Macklin EA, Ritchie C; Active Brains Project; Mace RA. Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial. JMIR Res Protoc. 2023 Sep 28;12:e47319. doi: 10.2196/47319.

  PMID: 37768713 DERIVED

MeSH Terms

Conditions

Chronic Pain; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Director

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 13, 2022
• Study Start: June 20, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)