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Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain

Primary Purpose

Chronic Pain, Mild Cognitive Impairment, Older Adults

Status
Completed
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

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female patients, age 60 years or older
  • Have nonmalignant chronic pain for more than 3 months
  • Has MCI or subjective memory related problems
  • Able to perform a 6-minute walk test at an accelerated pace
  • Owns a smartphone with Bluetooth 4.0
  • Willingness and ability to participate in the Active Brains intervention and to comply with the requirements of the study protocol (including weekly sessions and Fitbit use)
  • 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
  • Leads a sedentary lifestyle

Exclusion Criteria:

  • Diagnosed with medical illness expected to worsen in the next 6 months
  • Serious mental illness or instability for which hospitalization may be likely in the next 6 months
  • Current suicidal ideation reported on self-report
  • Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence
  • Current substance use disorder, within the past 6 months
  • Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less
  • Regular use of Fitbit in the last 3 months
  • Engagement in regular intensive physical exercise for >30 minute daily
  • Unable to walk without use of assistance (e.g., wheelchair, walker)

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Brains

Active Brains 2

Arm Description

Active Brains 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 reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). 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 digital monitoring device (i.e., Fitbit) for recording of physical activity.

This active comparison condition controls for the effect of time spent, group member support/feedback, and interventionist support/feedback. The original HEP was adapted to provide population-specific information on chronic pain and MCI/MRP 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 HEP program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The HEP is conducted in the same format as Active Brains-Fitbit but are not taught the mind-body, walking, or cognitive-behavioral skills. HEP participants are encouraged to set lifestyle goals instead of quota-based walking goals aided by the Fitbit as in the Active Brains-Fitbit condition.

Outcomes

Primary Outcome Measures

Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction

Secondary Outcome Measures

Proportion of Participants With Valid Digital Monitoring Device Wear
The proportion of patients with valid ActiGraph (digital monitoring device) wear for greater than or equal to 6 days (7+ hr/day) at baseline and 5 days at post test
Proportion of Participants With Valid Adherence to Homework
Proportion of participants completing at least 5 out of 7 days of homework assigned throughout the study
Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills
Percentage of audio recordings, progress notes, and checklists that were completed with 100% of content delivered for each session
Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)
Percentage of questionnaires that were entirely missing in >25% of participants and/or had an internal reliability below .70
Proportion of Participants Using Rescue (Non-Narcotic) Analgesics
Single-item question on demographics form indicating whether participant used rescue (non-narcotic) analgesics at baseline
Proportion of Participants Using Narcotic Analgesics
Single-item question on demographics form indicating whether participant used narcotic analgesics at baseline
Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
Number of participants rating expectations and believed credibility for the program above and below the scale midpoint, with higher ratings indicating more belief that the program is logical and will help with the intended outcome
Montreal Cognitive Assessment (MoCA)
Assesses several cognitive domains and detection of mild cognitive impairment (MCI), with scores ranging from 0-30 and lower scores indicating greater cognitive decline
Godin Leisure-Time Exercise Questionnaire
Rate of participant's leisure time and physical activity levels by indicating how many days per week are spent doing the activity for more than 15 minutes. Scores range from 0-119, with higher scores indicating greater levels of activity.
Measure of Current Status (MOCS-A)
Rate of a participant's self-reported perceived stress self-management skills, with items ranging from 0-4 and a total score ranging from 0-52, and higher scores reflecting more usage of stress self-management skills
The Measurement of Everyday Cognition (eCog)
Rate of participant's cognitively mediated functional abilities, with items ranging from 1-5. Total scores are an average of the items (range = 1-5), with higher scores indicating greater cognitive decline.
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 the worst possible pain
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness
WHO Disability Assessment Schedule 2.0
Rate of a participant's health and disability, with items ranging from 0-4, total scores ranging from 0-100, and higher scores reflecting greater disability
The Gratitude Questionnaire (GQ-6)
Rate of a participant's proneness to experience gratitude in daily life, with items ranging from 1-7, total scores ranging from 6-24, and a higher score indicating greater amount of gratitude
PROMIS Physical Function
Rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4, and total scores ranging from 8-40, with a higher score reflecting greater physical function
PROMIS Emotional Support
Rate of a participant's perceived feelings of being cared and values for as an individual, with items ranging from 1-5. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher perceived social support.
T-Score for PROMIS Depression
Rate of a participant's depressive symptoms, with items ranging from 1-5. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher depression.
T-Score for PROMIS Anxiety
Rate of a participant's fear, anxious, hyper arousal, and somatic symptoms pertaining to arousal. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher anxiety.
Pain Catastrophizing Scale (PCS)
Rate of a participant's pain experience, with items ranging from 0-4, and total scores ranging from 0-52, with higher scores indicating higher levels of pain catastrophizing
UCLA Loneliness Scale
Rate of a participant's feelings of loneliness and social isolation and items range from 0-3, with a higher score reflecting greater feelings of loneliness, with total scores ranging from 0-24
Pain Self Efficacy Questionnaire (PSEQ)
Rate of a participant's confidence to do various activities despite their pain, with items ranging from 0-6, and a higher score showing greater levels of confidence with pain self-efficacy, with total scores ranging from 0-60
Tampa Kinesiophobia Scale
Rate of a participant's fear of movement, with items ranging from 1-4, and a total scores ranging from 17-68, and higher scores indicating higher levels of fear of movement
Chronic Pain Acceptance Questionnaire
Rate of a participant's acceptance of chronic pain, with scores ranging from 0-6, with the total score ranging from 0-48, and higher scores indicating higher levels of acceptance of chronic pain
Self-Compassion Scale (SCS)
Rate of a participant's amount of self-compassion, with items ranging from 1-5, and total scores ranging from 12-60 and higher scores indicating higher levels of self-compassion
ActiGraph Average Steps
Participants wore a ActiGraph accelerometer around their waist for 8 days to measure their daily average step count.
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures the distances participants can walk at an accelerated pace in meters over a 6-minute span.

Full Information

First Posted
August 1, 2019
Last Updated
August 28, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04044183
Brief Title
Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain
Official Title
Active Brains: Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment (MCI) or Memory Related Problems (MRP) and Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)

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
We aim to conduct a pilot randomized controlled trial comparing 2 symptom management programs for older adults with self-reported memory problems and chronic pain, Active Brains 1 and Active Brains 2. We will assess how each program may help in improving coping with pain and coping with cognitive functioning. We will explore feasibility, acceptability, and credibility and within group changes in physical, emotional and cognitive functioning.
Detailed Description
We aim to conduct a pilot randomized controlled trial comparing 2 symptom management programs for older adults with self-reported memory problems and chronic pain: Active Brains 1 Active Brains 2. We will assess how each program may help in improving coping with pain and coping with cognitive functioning. We will explore feasibility, acceptability, and credibility and within group changes in physical, emotional and cognitive functioning. Each group meets for 8 90 minute sessions over a secure video platform. Each group has 5-8 participants. Participants receive a treatment manual. There are 2 assessment points: baseline, and post program. Assessments involve questionnaires, a walk test, and objective step count with ActiGraphs for 1 week.

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Active Brains
Arm Type
Experimental
Arm Description
Active Brains 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 reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). 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 digital monitoring device (i.e., Fitbit) 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. The original HEP was adapted to provide population-specific information on chronic pain and MCI/MRP 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 HEP program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The HEP is conducted in the same format as Active Brains-Fitbit but are not taught the mind-body, walking, or cognitive-behavioral skills. HEP participants are encouraged to set lifestyle goals instead of quota-based walking goals aided by the Fitbit as in the Active Brains-Fitbit condition.
Intervention Type
Behavioral
Intervention Name(s)
Active Brains 1
Intervention Description
Active Brains 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 reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). 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 digital monitoring device (i.e., Fitbit) 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. The original HEP was adapted to provide population-specific information on chronic pain and MCI/MRP 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 HEP program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The HEP is conducted in the same format as Active Brains-Fitbit but are not taught the mind-body, walking, or cognitive-behavioral skills. HEP participants are encouraged to set lifestyle goals instead of quota-based walking goals aided by the Fitbit as in the Active Brains-Fitbit condition.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
Description
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Proportion of Participants With Valid Digital Monitoring Device Wear
Description
The proportion of patients with valid ActiGraph (digital monitoring device) wear for greater than or equal to 6 days (7+ hr/day) at baseline and 5 days at post test
Time Frame
0 Weeks, 8 Weeks
Title
Proportion of Participants With Valid Adherence to Homework
Description
Proportion of participants completing at least 5 out of 7 days of homework assigned throughout the study
Time Frame
0 Weeks, 8 Weeks
Title
Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills
Description
Percentage of audio recordings, progress notes, and checklists that were completed with 100% of content delivered for each session
Time Frame
0 Weeks, 8 Weeks
Title
Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)
Description
Percentage of questionnaires that were entirely missing in >25% of participants and/or had an internal reliability below .70
Time Frame
0 Weeks, 8 Weeks
Title
Proportion of Participants Using Rescue (Non-Narcotic) Analgesics
Description
Single-item question on demographics form indicating whether participant used rescue (non-narcotic) analgesics at baseline
Time Frame
0 Weeks
Title
Proportion of Participants Using Narcotic Analgesics
Description
Single-item question on demographics form indicating whether participant used narcotic analgesics at baseline
Time Frame
0 Weeks
Title
Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
Description
Number of participants rating expectations and believed credibility for the program above and below the scale midpoint, with higher ratings indicating more belief that the program is logical and will help with the intended outcome
Time Frame
0 Weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
Assesses several cognitive domains and detection of mild cognitive impairment (MCI), with scores ranging from 0-30 and lower scores indicating greater cognitive decline
Time Frame
0 Weeks, 8 Weeks
Title
Godin Leisure-Time Exercise Questionnaire
Description
Rate of participant's leisure time and physical activity levels by indicating how many days per week are spent doing the activity for more than 15 minutes. Scores range from 0-119, with higher scores indicating greater levels of activity.
Time Frame
0 Weeks, 8 Weeks
Title
Measure of Current Status (MOCS-A)
Description
Rate of a participant's self-reported perceived stress self-management skills, with items ranging from 0-4 and a total score ranging from 0-52, and higher scores reflecting more usage of stress self-management skills
Time Frame
0 Weeks, 8 Weeks
Title
The Measurement of Everyday Cognition (eCog)
Description
Rate of participant's cognitively mediated functional abilities, with items ranging from 1-5. Total scores are an average of the items (range = 1-5), with higher scores indicating greater cognitive decline.
Time Frame
0 Weeks, 8 Weeks
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 the worst possible pain
Time Frame
0 Weeks, 8 Weeks
Title
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Description
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness
Time Frame
0 Weeks, 8 Weeks
Title
WHO Disability Assessment Schedule 2.0
Description
Rate of a participant's health and disability, with items ranging from 0-4, total scores ranging from 0-100, and higher scores reflecting greater disability
Time Frame
0 Weeks, 8 Weeks
Title
The Gratitude Questionnaire (GQ-6)
Description
Rate of a participant's proneness to experience gratitude in daily life, with items ranging from 1-7, total scores ranging from 6-24, and a higher score indicating greater amount of gratitude
Time Frame
0 Weeks, 8 Weeks
Title
PROMIS Physical Function
Description
Rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4, and total scores ranging from 8-40, with a higher score reflecting greater physical function
Time Frame
0 Weeks, 8 Weeks
Title
PROMIS Emotional Support
Description
Rate of a participant's perceived feelings of being cared and values for as an individual, with items ranging from 1-5. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher perceived social support.
Time Frame
0 Weeks, 8 Weeks
Title
T-Score for PROMIS Depression
Description
Rate of a participant's depressive symptoms, with items ranging from 1-5. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher depression.
Time Frame
0 Weeks, 8 Weeks
Title
T-Score for PROMIS Anxiety
Description
Rate of a participant's fear, anxious, hyper arousal, and somatic symptoms pertaining to arousal. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher anxiety.
Time Frame
0 Weeks, 8 Weeks
Title
Pain Catastrophizing Scale (PCS)
Description
Rate of a participant's pain experience, with items ranging from 0-4, and total scores ranging from 0-52, with higher scores indicating higher levels of pain catastrophizing
Time Frame
0 Weeks, 8 Weeks
Title
UCLA Loneliness Scale
Description
Rate of a participant's feelings of loneliness and social isolation and items range from 0-3, with a higher score reflecting greater feelings of loneliness, with total scores ranging from 0-24
Time Frame
0 Weeks, 8 Weeks
Title
Pain Self Efficacy Questionnaire (PSEQ)
Description
Rate of a participant's confidence to do various activities despite their pain, with items ranging from 0-6, and a higher score showing greater levels of confidence with pain self-efficacy, with total scores ranging from 0-60
Time Frame
0 Weeks, 8 Weeks
Title
Tampa Kinesiophobia Scale
Description
Rate of a participant's fear of movement, with items ranging from 1-4, and a total scores ranging from 17-68, and higher scores indicating higher levels of fear of movement
Time Frame
0 Weeks, 8 Weeks
Title
Chronic Pain Acceptance Questionnaire
Description
Rate of a participant's acceptance of chronic pain, with scores ranging from 0-6, with the total score ranging from 0-48, and higher scores indicating higher levels of acceptance of chronic pain
Time Frame
0 Weeks, 8 Weeks
Title
Self-Compassion Scale (SCS)
Description
Rate of a participant's amount of self-compassion, with items ranging from 1-5, and total scores ranging from 12-60 and higher scores indicating higher levels of self-compassion
Time Frame
0 Weeks, 8 Weeks
Title
ActiGraph Average Steps
Description
Participants wore a ActiGraph accelerometer around their waist for 8 days to measure their daily average step count.
Time Frame
0 weeks, 8 weeks
Title
Six-Minute Walk Test (6MWT)
Description
The Six-Minute Walk Test (6MWT) measures the distances participants can walk at an accelerated pace in meters over a 6-minute span.
Time Frame
0 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients, age 60 years or older Have nonmalignant chronic pain for more than 3 months Has MCI or subjective memory related problems Able to perform a 6-minute walk test at an accelerated pace Owns a smartphone with Bluetooth 4.0 Willingness and ability to participate in the Active Brains intervention and to comply with the requirements of the study protocol (including weekly sessions and Fitbit use) 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 Leads a sedentary lifestyle Exclusion Criteria: Diagnosed with medical illness expected to worsen in the next 6 months Serious mental illness or instability for which hospitalization may be likely in the next 6 months Current suicidal ideation reported on self-report Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, or substance dependence Current substance use disorder, within the past 6 months Practice of yoga/meditation, or other mind-body techniques that elicit the relaxation response, once per week for 45 minutes or more within the last 3 months or less Regular use of Fitbit in the last 3 months Engagement in regular intensive physical exercise for >30 minute daily Unable to walk without use of assistance (e.g., wheelchair, walker)
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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
derived
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
derived

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Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain

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