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

Not Applicable

Completed

Conditions: Physical Activity
Older Adults
Chronic Pain
Mild Cognitive Impairment

Interventions: Behavioral: Active Brains 1
Behavioral: Active Brains 2

Registration Number: NCT04044183

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Brains	Active Brains 2	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.
Active Brains 2	Active Brains 2	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.
Active Brains	Active Brains 1	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.
Active Brains 2	Active Brains 1	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 Measures

Name	Time	Method
Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint	8 Weeks	Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction

Secondary Outcome Measures

Name	Time	Method
Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills	0 Weeks, 8 Weeks	Percentage of audio recordings, progress notes, and checklists that were completed with 100% of content delivered for each session
Numerical Rating Scale	0 Weeks, 8 Weeks	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
WHO Disability Assessment Schedule 2.0	0 Weeks, 8 Weeks	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
PROMIS Emotional Support	0 Weeks, 8 Weeks	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.
Pain Self Efficacy Questionnaire (PSEQ)	0 Weeks, 8 Weeks	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
Proportion of Participants With Valid Digital Monitoring Device Wear	0 Weeks, 8 Weeks	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 Using Rescue (Non-Narcotic) Analgesics	0 Weeks	Single-item question on demographics form indicating whether participant used rescue (non-narcotic) analgesics at baseline
Measure of Current Status (MOCS-A)	0 Weeks, 8 Weeks	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 Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)	0 Weeks, 8 Weeks	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
Proportion of Participants With Valid Adherence to Homework	0 Weeks, 8 Weeks	Proportion of participants completing at least 5 out of 7 days of homework assigned throughout the study
Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)	0 Weeks, 8 Weeks	Percentage of questionnaires that were entirely missing in \>25% of participants and/or had an internal reliability below .70
Montreal Cognitive Assessment (MoCA)	0 Weeks, 8 Weeks	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	0 Weeks, 8 Weeks	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.
Six-Minute Walk Test (6MWT)	0 weeks, 8 weeks	The Six-Minute Walk Test (6MWT) measures the distances participants can walk at an accelerated pace in meters over a 6-minute span.
Proportion of Participants Using Narcotic Analgesics	0 Weeks	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	0 Weeks	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
The Measurement of Everyday Cognition (eCog)	0 Weeks, 8 Weeks	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.
Pain Catastrophizing Scale (PCS)	0 Weeks, 8 Weeks	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	0 Weeks, 8 Weeks	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
Chronic Pain Acceptance Questionnaire	0 Weeks, 8 Weeks	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
The Gratitude Questionnaire (GQ-6)	0 Weeks, 8 Weeks	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	0 Weeks, 8 Weeks	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
T-Score for PROMIS Depression	0 Weeks, 8 Weeks	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	0 Weeks, 8 Weeks	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.
Self-Compassion Scale (SCS)	0 Weeks, 8 Weeks	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	0 weeks, 8 weeks	Participants wore a ActiGraph accelerometer around their waist for 8 days to measure their daily average step count.
Tampa Kinesiophobia Scale	0 Weeks, 8 Weeks	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