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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PROMIS Pain Interference - Short Form 6b V1.0 | Change in the self-reported consequences of pain on relevant aspects of a person's life, with items ranging from 0 to 5. Higher T scores indicate greater pain interference. | 0 Weeks, 8 Weeks, 6 Months |
| Pain Catastrophizing Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana-Maria Vranceanu, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33208301 | Background | 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. | |
| 33159516 | 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. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
|
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 |
Rate of a participant's hopelessness, helplessness, and rumination about pain, with items ranging from 0 to 4, total scores ranging from 0 to 52, and higher scores indicating higher levels of pain catastrophizing. |
| 0 Weeks, 8 Weeks, 6 Months |
| Tampa Kinesiophobia Scale | Rate of a participant's fear of movement, with items ranging from 1-4, total scores ranging from 17 to 68, and higher scores indicating higher levels of fear of movement. | 0 Weeks, 8 Weeks, 6 Months |
| Pain Self-Efficacy | Rate of a participant's confidence to do various activities despite their pain, with items ranging from 0-6, total scores ranging from 0-60, and a higher score showing greater levels of confidence with pain self-efficacy. | 0 Weeks, 8 Weeks, 6 Months |
| Self-Compassion Scale | Rate of a participant's amount of self-compassion, with items ranging from 1-5. Scores are calculated by averaging the 12 items, and range from 1-5, with higher scores indicating higher levels of self-compassion. | 0 Weeks, 8 Weeks, 6 Months |
| Measure of Current Status | Rate of a participant's self-reported perceived stress self-management skills, with items ranging from 0-4, total scores ranging from 0-52, and higher scores reflecting more usage of stress self-management skills. | 0 Weeks, 8 Weeks, 6 Months |
| Gratitude Questionnaire | Rate of a participant's proneness to experience gratitude in daily life, with items ranging from 1-7, total scores ranging from 6-42, and a higher score indicating greater amount of gratitude. | 0 Weeks, 8 Weeks, 6 Months |
| Toronto Mindfulness Scale | Rate of a participant's state mindfulness in the moment, with items ranging from 1-4, total scores ranging from 13-52, and a higher score indicating a greater amount of state-level mindfulness. | 0 Weeks, 8 Weeks, 6 Months |
| NIH Toolbox Item Bank v2.0 - Loneliness (Ages 18+) - Fixed Form | Measure of an individual's perceptions that one is alone, lonely, or socially isolated from others, with items ranging from 1-5. Higher T scores indicate a greater degree of loneliness. | 0 Weeks, 8 Weeks, 6 Months |
| PROMIS Satisfaction with Social Roles and Activities | Rate of a participant's perceived satisfaction with social functioning, with items ranging from 1-5. Higher T scores indicate higher satisfaction with social functioning. | 0 Weeks, 8 Weeks, 6 Months |
| Memory Compensation Questionnaire | Rate of a participant's use of cognitive compensatory strategies for actual or perceived memory loss, with items ranging from 0-4, total scores ranging from 0-52, and higher scores reflecting greater use of compensatory strategies. | 0 Weeks, 8 Weeks, 6 Months |
| The Pain, Enjoyment of Life and General Activity (PEG) Scale | 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. | 1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks |
| Global Cognitive and Social Engagement | Rate of a participant's perceived engagement in mentally stimulating social and cognitive activities, with items ranging from 0-4, total scores ranging from 0 to 20, and higher scores indicating higher perceived activity engagement. | 0 Weeks, 8 Weeks, 6 Months |
| Quota-Based Pacing | Rate of a participant's perceived use of quota-based activity pacing. Items range from 0-4, and total scores range from 0-16, with higher scores indicating greater use of quota-based pacing. | 0 Weeks, 8 Weeks, 6 Months |
| Pain Interference Weekly Measure | Brief measure assessing the degree to which pain interferes with a participant's ability to meet their step count goal and degree to which it contributes to memory-related problems. Items range from 1-5, total scores range from 2-10, with higher scores indicating higher pain interference. Only administered to the Active Brains 1 group. | 1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks |
| 32601670 | 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. |
| 34487167 | 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. |
| 37768713 | Derived | 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. |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |