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

Not Applicable

Recruiting

• Conditions: Physical Activity; Chronic Pain; Mild Cognitive Impairment; Older Adults

• Registration Number: NCT05373745
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-13
• Study Start: 2022-06-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in six-minute walk test (6MWT)	0 Weeks, 8 Weeks, 6 Months	Assesses distance walked in 6 minutes.
Change in PROMIS Physical Function	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. Higher T scores indicate greater physical function.
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer	0 Weeks, 8 Weeks, 6 Months	Measures the change in steps during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up.

Secondary Outcome Measures

Name	Time	Method
PROMIS Depression	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. Higher T scores indicate higher levels of depression.
PROMIS Anxiety	0 Weeks, 8 Weeks, 6 Months	Rate of a participant's fear, anxious, hyperarousal and somatic symptoms pertaining to arousal, with items ranging from 1-5. Higher T scores indicate higher levels of anxiety.
Everyday Cognition Scale (eCog-12)	0 Weeks, 8 Weeks, 6 Months	Rate of participant's cognitively mediated functional abilities, with items ranging from 1-5. Scores are calculated by averaging the 12 items, and range from 1-5, with higher scores indicating greater cognitive decline.
Numerical Rating Scale	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.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	0 Weeks, 8 Weeks, 6 Months	A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States