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

Primary Purpose

Chronic Pain, Mild Cognitive Impairment, Older Adults

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Brains 1
Active Brains 2
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity, Memory Related Problems, Early Cognitive Decline

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Brains 1

Active Brains 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Change in six-minute walk test (6MWT)
Assesses distance walked in 6 minutes.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 15, 2022
Last Updated
March 1, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05373745
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Brains 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Brains 2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Brains 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Brains 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in PROMIS Physical Function
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer
Description
Measures the change in steps during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Change in six-minute walk test (6MWT)
Description
Assesses distance walked in 6 minutes.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Secondary Outcome Measure Information:
Title
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description
A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Everyday Cognition Scale (eCog-12)
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
PROMIS Depression
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
PROMIS Anxiety
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Numerical Rating Scale
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Other Pre-specified Outcome Measures:
Title
Change in PROMIS Pain Interference - Short Form 6b V1.0
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Pain Catastrophizing Scale
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Tampa Kinesiophobia Scale
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Pain Self-Efficacy
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Self-Compassion Scale
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Measure of Current Status
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Gratitude Questionnaire
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Toronto Mindfulness Scale
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
NIH Toolbox Item Bank v2.0 - Loneliness (Ages 18+) - Fixed Form
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
PROMIS Satisfaction with Social Roles and Activities
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Memory Compensation Questionnaire
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
The Pain, Enjoyment of Life and General Activity (PEG) Scale
Description
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.
Time Frame
1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks
Title
Global Cognitive and Social Engagement
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Quota-Based Pacing
Description
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.
Time Frame
0 Weeks, 8 Weeks, 6 Months
Title
Pain Interference Weekly Measure
Description
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.
Time Frame
1 Week, 2 Weeks, 3 Weeks, 4 Weeks, 5 Weeks, 6 Weeks, 7 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana-Maria Vranceanu, PhD
Phone
6176437996
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan A Mace, PhD
Phone
6176437641
Email
rmace@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Phone
617-643-7996
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ryan A Mace, PhD
Phone
6176437641
Email
rmace@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33208301
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.
Results Reference
background
PubMed Identifier
33159516
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.
Results Reference
background
PubMed Identifier
32601670
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.
Results Reference
background
PubMed Identifier
34487167
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.
Results Reference
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Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain

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