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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity

Intervention / Treatment
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* Behavioral: Active Brains 1
* Behavioral: Active Brains 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Brains 1<br>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<br>* 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.<br>|
| Placebo Comparator: Active Brains 2<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition. | 0 Weeks, 8 Weeks, 6 Months | 
| Everyday Cognition Scale (eCog-12) | 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. | 0 Weeks, 8 Weeks, 6 Months | 
| PROMIS Depression | 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. | 0 Weeks, 8 Weeks, 6 Months | 
| PROMIS Anxiety | 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. | 0 Weeks, 8 Weeks, 6 Months | 
| Numerical Rating Scale | 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. | 0 Weeks, 8 Weeks, 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity, Memory Related Problems, Early Cognitive Decline