Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity
Conditions
Keywords
Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity, Memory Related Problems
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.
Interventions
BEHAVIORALActive 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.
BEHAVIORALActive 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 11 |
| Total | 20 |
Baseline characteristics
| Characteristic | Active Brains | Active Brains 2 | Total |
|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 5.9 | 70.8 years STANDARD_DEVIATION 8.4 | 69.9 years STANDARD_DEVIATION 7.3 |
| Cognitive status Cognitive Impairment | 5 Participants | 3 Participants | 8 Participants |
| Cognitive status Normal | 4 Participants | 8 Participants | 12 Participants |
| Education Completed college (16 years) | 3 Participants | 2 Participants | 5 Participants |
| Education Completed high school or GED (12 years) | 0 Participants | 1 Participants | 1 Participants |
| Education Graduate/professional degree (>16 years) | 3 Participants | 5 Participants | 8 Participants |
| Education Some college/Associates degree (<16 years) | 3 Participants | 3 Participants | 6 Participants |
| Employment Employed full-time | 0 Participants | 1 Participants | 1 Participants |
| Employment Employed part-time | 1 Participants | 1 Participants | 2 Participants |
| Employment Other situation | 3 Participants | 2 Participants | 5 Participants |
| Employment Retired | 4 Participants | 6 Participants | 10 Participants |
| Employment Unemployed | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 11 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Living with significant other | 3 Participants | 6 Participants | 9 Participants |
| Marital Status Married | 1 Participants | 0 Participants | 1 Participants |
| Marital Status Separated/Divorced | 2 Participants | 3 Participants | 5 Participants |
| Marital Status Single, never married | 0 Participants | 1 Participants | 1 Participants |
| Marital Status Widowed | 3 Participants | 1 Participants | 4 Participants |
| Pain duration 6-10 years | 2 Participants | 3 Participants | 5 Participants |
| Pain duration Greater than or equal to 11 years | 3 Participants | 6 Participants | 9 Participants |
| Pain duration Less than or equal to 5 years | 4 Participants | 2 Participants | 6 Participants |
| Pain medications None | 2 Participants | 3 Participants | 5 Participants |
| Pain medications Opioids | 2 Participants | 4 Participants | 6 Participants |
| Pain medications Other analgesics | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 10 Participants | 17 Participants |
| Region of Enrollment United States | 9 Participants | 11 Participants | 20 Participants |
| Reported pain location Lower | 2 Participants | 0 Participants | 2 Participants |
| Reported pain location Multi-site | 4 Participants | 7 Participants | 11 Participants |
| Reported pain location Upper | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Brains | Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint | Did not complete the scale | 1 Participants |
| Active Brains | Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint | Scored above the scale midpoint | 8 Participants |
| Active Brains | Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint | Scored below the scale midpoint | 0 Participants |
| Active Brains 2 | Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint | Did not complete the scale | 1 Participants |
| Active Brains 2 | Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint | Scored above the scale midpoint | 9 Participants |
| Active Brains 2 | Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint | Scored below the scale midpoint | 1 Participants |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | ActiGraph Average Steps | Baseline | 3643.1 steps per day | Standard Deviation 1679.9 |
| Active Brains | ActiGraph Average Steps | Post-Test | 4283.8 steps per day | Standard Deviation 1905.7 |
| Active Brains 2 | ActiGraph Average Steps | Post-Test | 2604.4 steps per day | Standard Deviation 1912.8 |
| Active Brains 2 | ActiGraph Average Steps | Baseline | 3195.3 steps per day | Standard Deviation 1975.7 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Chronic Pain Acceptance Questionnaire | Baseline | 30.1 score on a scale | Standard Deviation 8.7 |
| Active Brains | Chronic Pain Acceptance Questionnaire | Post-Test | 31 score on a scale | Standard Deviation 8.2 |
| Active Brains 2 | Chronic Pain Acceptance Questionnaire | Baseline | 24.3 score on a scale | Standard Deviation 10.7 |
| Active Brains 2 | Chronic Pain Acceptance Questionnaire | Post-Test | 27.1 score on a scale | Standard Deviation 3.7 |
Secondary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Active Brains | Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint | Credibility | Scored above the scale midpoint | 9 Participants |
| Active Brains | Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint | Credibility | Scored below the scale midpoint | 0 Participants |
| Active Brains | Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint | Expectancy | Scored above the scale midpoint | 5 Participants |
| Active Brains | Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint | Expectancy | Scored below the scale midpoint | 4 Participants |
| Active Brains 2 | Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint | Expectancy | Scored below the scale midpoint | 7 Participants |
| Active Brains 2 | Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint | Expectancy | Scored above the scale midpoint | 4 Participants |
| Active Brains 2 | Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint | Credibility | Scored below the scale midpoint | 0 Participants |
| Active Brains 2 | Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint | Credibility | Scored above the scale midpoint | 11 Participants |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Godin Leisure-Time Exercise Questionnaire | Baseline | 36 score on a scale | Standard Deviation 34.9 |
| Active Brains | Godin Leisure-Time Exercise Questionnaire | Post-Test | 74 score on a scale | Standard Deviation 57.5 |
| Active Brains 2 | Godin Leisure-Time Exercise Questionnaire | Baseline | 20 score on a scale | Standard Deviation 20.9 |
| Active Brains 2 | Godin Leisure-Time Exercise Questionnaire | Post-Test | 30.8 score on a scale | Standard Deviation 35.8 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Measure of Current Status (MOCS-A) | Baseline | 30.4 score on a scale | Standard Deviation 12.4 |
| Active Brains | Measure of Current Status (MOCS-A) | Post-Test | 36.1 score on a scale | Standard Deviation 14.2 |
| Active Brains 2 | Measure of Current Status (MOCS-A) | Baseline | 25.6 score on a scale | Standard Deviation 10.1 |
| Active Brains 2 | Measure of Current Status (MOCS-A) | Post-Test | 28.3 score on a scale | Standard Deviation 8.7 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Montreal Cognitive Assessment (MoCA) | Baseline | 24.8 score on a scale | Standard Deviation 2.4 |
| Active Brains | Montreal Cognitive Assessment (MoCA) | Post-Test | 26.2 score on a scale | Standard Deviation 1.7 |
| Active Brains 2 | Montreal Cognitive Assessment (MoCA) | Baseline | 26.3 score on a scale | Standard Deviation 3.5 |
| Active Brains 2 | Montreal Cognitive Assessment (MoCA) | Post-Test | 26.6 score on a scale | Standard Deviation 3.7 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Numerical Rating Scale | Pain at rest (Baseline) | 5.9 score on a scale | Standard Deviation 2.5 |
| Active Brains | Numerical Rating Scale | Pain with activity (Baseline) | 6.2 score on a scale | Standard Deviation 1.8 |
| Active Brains | Numerical Rating Scale | Pain at rest (Post-Test) | 3.9 score on a scale | Standard Deviation 2.1 |
| Active Brains | Numerical Rating Scale | Pain with activity (Post-Test) | 4.2 score on a scale | Standard Deviation 2.5 |
| Active Brains 2 | Numerical Rating Scale | Pain at rest (Post-Test) | 4.3 score on a scale | Standard Deviation 1.8 |
| Active Brains 2 | Numerical Rating Scale | Pain at rest (Baseline) | 4.4 score on a scale | Standard Deviation 2.6 |
| Active Brains 2 | Numerical Rating Scale | Pain with activity (Post-Test) | 5.7 score on a scale | Standard Deviation 2.2 |
| Active Brains 2 | Numerical Rating Scale | Pain with activity (Baseline) | 5.7 score on a scale | Standard Deviation 2.6 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Pain Catastrophizing Scale (PCS) | Baseline | 9.4 score on a scale | Standard Deviation 6.8 |
| Active Brains | Pain Catastrophizing Scale (PCS) | Post-Test | 7.1 score on a scale | Standard Deviation 5.6 |
| Active Brains 2 | Pain Catastrophizing Scale (PCS) | Baseline | 11.6 score on a scale | Standard Deviation 9.4 |
| Active Brains 2 | Pain Catastrophizing Scale (PCS) | Post-Test | 11 score on a scale | Standard Deviation 7.1 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Pain Self Efficacy Questionnaire (PSEQ) | Baseline | 38 score on a scale | Standard Deviation 14.2 |
| Active Brains | Pain Self Efficacy Questionnaire (PSEQ) | Post-Test | 42.9 score on a scale | Standard Deviation 14.5 |
| Active Brains 2 | Pain Self Efficacy Questionnaire (PSEQ) | Baseline | 35.5 score on a scale | Standard Deviation 18.9 |
| Active Brains 2 | Pain Self Efficacy Questionnaire (PSEQ) | Post-Test | 38 score on a scale | Standard Deviation 13.5 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Brains | Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures) | 85 Percentage of questionnaires were entire |
| Active Brains 2 | Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures) | 99 Percentage of questionnaires were entire |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | PROMIS Emotional Support | Baseline | 51.1 score on a scale | Standard Deviation 11.2 |
| Active Brains | PROMIS Emotional Support | Post-Test | 52.1 score on a scale | Standard Deviation 9.1 |
| Active Brains 2 | PROMIS Emotional Support | Baseline | 49.4 score on a scale | Standard Deviation 9.6 |
| Active Brains 2 | PROMIS Emotional Support | Post-Test | 48.8 score on a scale | Standard Deviation 9.5 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | PROMIS Physical Function | Baseline | 39.9 score on a scale | Standard Deviation 5.5 |
| Active Brains | PROMIS Physical Function | Post-Test | 43.4 score on a scale | Standard Deviation 9.6 |
| Active Brains 2 | PROMIS Physical Function | Baseline | 37.1 score on a scale | Standard Deviation 6.2 |
| Active Brains 2 | PROMIS Physical Function | Post-Test | 38.2 score on a scale | Standard Deviation 5.8 |
Secondary
Proportion of Participants Using Narcotic Analgesics
Single-item question on demographics form indicating whether participant used narcotic analgesics at baseline
Time frame: 0 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Brains | Proportion of Participants Using Narcotic Analgesics | 2 Participants |
| Active Brains 2 | Proportion of Participants Using Narcotic Analgesics | 4 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Brains | Proportion of Participants Using Rescue (Non-Narcotic) Analgesics | 4 Participants |
| Active Brains 2 | Proportion of Participants Using Rescue (Non-Narcotic) Analgesics | 5 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Brains | Proportion of Participants With Valid Adherence to Homework | Completed ≥ 5 of seven homework logs | 8 Participants |
| Active Brains | Proportion of Participants With Valid Adherence to Homework | Did not complete ≥ 5 of seven homework logs | 1 Participants |
| Active Brains 2 | Proportion of Participants With Valid Adherence to Homework | Completed ≥ 5 of seven homework logs | 0 Participants |
| Active Brains 2 | Proportion of Participants With Valid Adherence to Homework | Did not complete ≥ 5 of seven homework logs | 11 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Brains | Proportion of Participants With Valid Digital Monitoring Device Wear | Wore the FitBit for at least 5 out of 7 days for 6 out of the 8 weeks of the program | 8 Participants |
| Active Brains | Proportion of Participants With Valid Digital Monitoring Device Wear | Did not wear the FitBit for at least 5 out of 7 days for 6 out of the 8 weeks of the program | 1 Participants |
| Active Brains 2 | Proportion of Participants With Valid Digital Monitoring Device Wear | Wore the FitBit for at least 5 out of 7 days for 6 out of the 8 weeks of the program | 0 Participants |
| Active Brains 2 | Proportion of Participants With Valid Digital Monitoring Device Wear | Did not wear the FitBit for at least 5 out of 7 days for 6 out of the 8 weeks of the program | 11 Participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Brains | Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills | 97.3 percentage of therapist adherence |
| Active Brains 2 | Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills | 91.4 percentage of therapist adherence |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Self-Compassion Scale (SCS) | Baseline | 45.6 score on a scale | Standard Deviation 7.9 |
| Active Brains | Self-Compassion Scale (SCS) | Post-Test | 43.2 score on a scale | Standard Deviation 7.4 |
| Active Brains 2 | Self-Compassion Scale (SCS) | Baseline | 44.4 score on a scale | Standard Deviation 8.5 |
| Active Brains 2 | Self-Compassion Scale (SCS) | Post-Test | 43.6 score on a scale | Standard Deviation 6.9 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Six-Minute Walk Test (6MWT) | Baseline | 407.6 meters per 6 minutes | Standard Deviation 110.2 |
| Active Brains | Six-Minute Walk Test (6MWT) | Post-Test | 426.6 meters per 6 minutes | Standard Deviation 147.6 |
| Active Brains 2 | Six-Minute Walk Test (6MWT) | Baseline | 415.6 meters per 6 minutes | Standard Deviation 123.1 |
| Active Brains 2 | Six-Minute Walk Test (6MWT) | Post-Test | 435.2 meters per 6 minutes | Standard Deviation 101.6 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | Tampa Kinesiophobia Scale | Baseline | 31.9 score on a scale | Standard Deviation 6.2 |
| Active Brains | Tampa Kinesiophobia Scale | Post-Test | 31.2 score on a scale | Standard Deviation 13.5 |
| Active Brains 2 | Tampa Kinesiophobia Scale | Baseline | 37.6 score on a scale | Standard Deviation 8.9 |
| Active Brains 2 | Tampa Kinesiophobia Scale | Post-Test | 35.8 score on a scale | Standard Deviation 7.4 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) | Baseline | 31.9 score on a scale | Standard Deviation 7.3 |
| Active Brains | The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) | Post-Test | 33.9 score on a scale | Standard Deviation 6.1 |
| Active Brains 2 | The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) | Baseline | 33.8 score on a scale | Standard Deviation 8 |
| Active Brains 2 | The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) | Post-Test | 35.3 score on a scale | Standard Deviation 6 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | The Gratitude Questionnaire (GQ-6) | Post-Test | 35.5 score on a scale | Standard Deviation 7.1 |
| Active Brains | The Gratitude Questionnaire (GQ-6) | Baseline | 36.2 score on a scale | Standard Deviation 5.9 |
| Active Brains 2 | The Gratitude Questionnaire (GQ-6) | Baseline | 32.5 score on a scale | Standard Deviation 7.6 |
| Active Brains 2 | The Gratitude Questionnaire (GQ-6) | Post-Test | 35.9 score on a scale | Standard Deviation 5.1 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | The Measurement of Everyday Cognition (eCog) | Baseline | 2.3 mean of items | Standard Deviation 1 |
| Active Brains | The Measurement of Everyday Cognition (eCog) | Post-Test | 2 mean of items | Standard Deviation 0.9 |
| Active Brains 2 | The Measurement of Everyday Cognition (eCog) | Baseline | 1.9 mean of items | Standard Deviation 0.6 |
| Active Brains 2 | The Measurement of Everyday Cognition (eCog) | Post-Test | 1.8 mean of items | Standard Deviation 0.5 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | T-Score for PROMIS Anxiety | Baseline | 51 score on a scale | Standard Deviation 10 |
| Active Brains | T-Score for PROMIS Anxiety | Post-Test | 47.9 score on a scale | Standard Deviation 10.2 |
| Active Brains 2 | T-Score for PROMIS Anxiety | Baseline | 52.9 score on a scale | Standard Deviation 10.1 |
| Active Brains 2 | T-Score for PROMIS Anxiety | Post-Test | 53.7 score on a scale | Standard Deviation 11 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | T-Score for PROMIS Depression | Baseline | 51.6 T-score | Standard Deviation 6.6 |
| Active Brains | T-Score for PROMIS Depression | Post-Test | 52.5 T-score | Standard Deviation 8.6 |
| Active Brains 2 | T-Score for PROMIS Depression | Baseline | 55.6 T-score | Standard Deviation 11.1 |
| Active Brains 2 | T-Score for PROMIS Depression | Post-Test | 54.3 T-score | Standard Deviation 11.7 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | UCLA Loneliness Scale | Baseline | 12.9 score on a scale | Standard Deviation 3.3 |
| Active Brains | UCLA Loneliness Scale | Post-Test | 12.6 score on a scale | Standard Deviation 5.2 |
| Active Brains 2 | UCLA Loneliness Scale | Baseline | 13.4 score on a scale | Standard Deviation 4.4 |
| Active Brains 2 | UCLA Loneliness Scale | Post-Test | 13.3 score on a scale | Standard Deviation 3.6 |
Secondary
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
Population: Participant dropout as cited in consort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Brains | WHO Disability Assessment Schedule 2.0 | Baseline | 17.1 score on a scale | Standard Deviation 14.3 |
| Active Brains | WHO Disability Assessment Schedule 2.0 | Post-Test | 16 score on a scale | Standard Deviation 14.7 |
| Active Brains 2 | WHO Disability Assessment Schedule 2.0 | Baseline | 23.9 score on a scale | Standard Deviation 17.2 |
| Active Brains 2 | WHO Disability Assessment Schedule 2.0 | Post-Test | 22.2 score on a scale | Standard Deviation 15 |