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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
21
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
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
Time frame: 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
Proportion of Participants Using Rescue (Non-Narcotic) Analgesics
Single-item question on demographics form indicating whether participant used rescue (non-narcotic) analgesics at baseline
Time frame: 0 Weeks
Proportion of Participants Using Narcotic Analgesics
Single-item question on demographics form indicating whether participant used narcotic analgesics at baseline
Time frame: 0 Weeks
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
Time frame: 0 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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.
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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.
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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.
Time frame: 0 Weeks, 8 Weeks
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.
Time frame: 0 Weeks, 8 Weeks
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.
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
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
Time frame: 0 Weeks, 8 Weeks
ActiGraph Average Steps
Participants wore a ActiGraph accelerometer around their waist for 8 days to measure their daily average step count.
Time frame: 0 weeks, 8 weeks
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.
Time frame: 0 weeks, 8 weeks
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