Clinical trial NCT04044183: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Mild Cognitive Impairment
Older Adults
Physical Activity
Keywords: Chronic Pain
Mild Cognitive Impairment
Older Adults
Physical Activity
Memory Related Problems
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 21
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
timeFrame: 8 Weeks
Secondary outcomes:
measure: Proportion of Participants With Valid Digital Monitoring Device Wear
timeFrame: 0 Weeks, 8 Weeks
measure: Proportion of Participants With Valid Adherence to Homework
timeFrame: 0 Weeks, 8 Weeks
measure: Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills
timeFrame: 0 Weeks, 8 Weeks
measure: Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)
timeFrame: 0 Weeks, 8 Weeks
measure: Proportion of Participants Using Rescue (Non-Narcotic) Analgesics
timeFrame: 0 Weeks
measure: Proportion of Participants Using Narcotic Analgesics
timeFrame: 0 Weeks
measure: Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
timeFrame: 0 Weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 0 Weeks, 8 Weeks
measure: Godin Leisure-Time Exercise Questionnaire
timeFrame: 0 Weeks, 8 Weeks
measure: Measure of Current Status (MOCS-A)
timeFrame: 0 Weeks, 8 Weeks
measure: The Measurement of Everyday Cognition (eCog)
timeFrame: 0 Weeks, 8 Weeks
measure: Numerical Rating Scale
timeFrame: 0 Weeks, 8 Weeks
measure: The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
timeFrame: 0 Weeks, 8 Weeks
measure: WHO Disability Assessment Schedule 2.0
timeFrame: 0 Weeks, 8 Weeks
measure: The Gratitude Questionnaire (GQ-6)
timeFrame: 0 Weeks, 8 Weeks
measure: PROMIS Physical Function
timeFrame: 0 Weeks, 8 Weeks
measure: PROMIS Emotional Support
timeFrame: 0 Weeks, 8 Weeks
measure: T-Score for PROMIS Depression
timeFrame: 0 Weeks, 8 Weeks
measure: T-Score for PROMIS Anxiety
timeFrame: 0 Weeks, 8 Weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 0 Weeks, 8 Weeks
measure: UCLA Loneliness Scale
timeFrame: 0 Weeks, 8 Weeks
measure: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: 0 Weeks, 8 Weeks
measure: Tampa Kinesiophobia Scale
timeFrame: 0 Weeks, 8 Weeks
measure: Chronic Pain Acceptance Questionnaire
timeFrame: 0 Weeks, 8 Weeks
measure: Self-Compassion Scale (SCS)
timeFrame: 0 Weeks, 8 Weeks
measure: ActiGraph Average Steps
timeFrame: 0 weeks, 8 weeks
measure: Six-Minute Walk Test (6MWT)
timeFrame: 0 weeks, 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.