Trial Outcomes & Findings for Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain (NCT NCT04044183)
NCT ID: NCT04044183
Last Updated: 2023-07-20
Results Overview
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
8 Weeks
Results posted on
2023-07-20
Participant Flow
Participant milestones
| Measure |
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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain
Baseline characteristics by cohort
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 5.9 • n=93 Participants
|
70.8 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
69.9 years
STANDARD_DEVIATION 7.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Marital Status
Single, never married
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Marital Status
Living with significant other
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Marital Status
Married
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Marital Status
Separated/Divorced
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Marital Status
Widowed
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Education
Completed high school or GED (12 years)
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Education
Some college/Associates degree (<16 years)
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Education
Completed college (16 years)
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Education
Graduate/professional degree (>16 years)
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Employment
Employed full-time
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Employment
Employed part-time
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Employment
Retired
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Employment
Unemployed
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Employment
Other situation
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Pain medications
Opioids
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Pain medications
Other analgesics
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Pain medications
None
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Reported pain location
Upper
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Reported pain location
Lower
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Reported pain location
Multi-site
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Pain duration
Less than or equal to 5 years
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Pain duration
6-10 years
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Pain duration
Greater than or equal to 11 years
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Cognitive status
Normal
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Cognitive status
Cognitive Impairment
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 WeeksItems are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
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|---|---|---|
|
Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
Scored above the scale midpoint
|
8 Participants
|
9 Participants
|
|
Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
Scored below the scale midpoint
|
0 Participants
|
1 Participants
|
|
Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
Did not complete the scale
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksThe 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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
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|---|---|---|
|
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
|
0 Participants
|
|
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
|
11 Participants
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksProportion of participants completing at least 5 out of 7 days of homework assigned throughout the study
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Proportion of Participants With Valid Adherence to Homework
Completed ≥ 5 of seven homework logs
|
8 Participants
|
0 Participants
|
|
Proportion of Participants With Valid Adherence to Homework
Did not complete ≥ 5 of seven homework logs
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPercentage of audio recordings, progress notes, and checklists that were completed with 100% of content delivered for each session
Outcome measures
| Measure |
Active Brains
n=8 Sessions
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
n=8 Sessions
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.
|
|---|---|---|
|
Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills
|
97.3 percentage of therapist adherence
|
91.4 percentage of therapist adherence
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPercentage of questionnaires that were entirely missing in \>25% of participants and/or had an internal reliability below .70
Outcome measures
| Measure |
Active Brains
n=19 Questionnaires
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
n=19 Questionnaires
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.
|
|---|---|---|
|
Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)
|
85 Percentage of questionnaires were entire
|
99 Percentage of questionnaires were entire
|
SECONDARY outcome
Timeframe: 0 WeeksSingle-item question on demographics form indicating whether participant used rescue (non-narcotic) analgesics at baseline
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Proportion of Participants Using Rescue (Non-Narcotic) Analgesics
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 0 WeeksSingle-item question on demographics form indicating whether participant used narcotic analgesics at baseline
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Proportion of Participants Using Narcotic Analgesics
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 WeeksNumber 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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
Credibility · Scored above the scale midpoint
|
9 Participants
|
11 Participants
|
|
Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
Credibility · Scored below the scale midpoint
|
0 Participants
|
0 Participants
|
|
Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
Expectancy · Scored above the scale midpoint
|
5 Participants
|
4 Participants
|
|
Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
Expectancy · Scored below the scale midpoint
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
Assesses several cognitive domains and detection of mild cognitive impairment (MCI), with scores ranging from 0-30 and lower scores indicating greater cognitive decline
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
Baseline
|
24.8 score on a scale
Standard Deviation 2.4
|
26.3 score on a scale
Standard Deviation 3.5
|
|
Montreal Cognitive Assessment (MoCA)
Post-Test
|
26.2 score on a scale
Standard Deviation 1.7
|
26.6 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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.
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Godin Leisure-Time Exercise Questionnaire
Baseline
|
36 score on a scale
Standard Deviation 34.9
|
20 score on a scale
Standard Deviation 20.9
|
|
Godin Leisure-Time Exercise Questionnaire
Post-Test
|
74 score on a scale
Standard Deviation 57.5
|
30.8 score on a scale
Standard Deviation 35.8
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Measure of Current Status (MOCS-A)
Baseline
|
30.4 score on a scale
Standard Deviation 12.4
|
25.6 score on a scale
Standard Deviation 10.1
|
|
Measure of Current Status (MOCS-A)
Post-Test
|
36.1 score on a scale
Standard Deviation 14.2
|
28.3 score on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksRate 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.
Outcome measures
| Measure |
Active Brains
n=8 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
The Measurement of Everyday Cognition (eCog)
Baseline
|
2.3 mean of items
Standard Deviation 1
|
1.9 mean of items
Standard Deviation 0.6
|
|
The Measurement of Everyday Cognition (eCog)
Post-Test
|
2 mean of items
Standard Deviation 0.9
|
1.8 mean of items
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Numerical Rating Scale
Pain at rest (Baseline)
|
5.9 score on a scale
Standard Deviation 2.5
|
4.4 score on a scale
Standard Deviation 2.6
|
|
Numerical Rating Scale
Pain at rest (Post-Test)
|
3.9 score on a scale
Standard Deviation 2.1
|
4.3 score on a scale
Standard Deviation 1.8
|
|
Numerical Rating Scale
Pain with activity (Baseline)
|
6.2 score on a scale
Standard Deviation 1.8
|
5.7 score on a scale
Standard Deviation 2.6
|
|
Numerical Rating Scale
Pain with activity (Post-Test)
|
4.2 score on a scale
Standard Deviation 2.5
|
5.7 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksRate 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
Outcome measures
| Measure |
Active Brains
n=8 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Baseline
|
31.9 score on a scale
Standard Deviation 7.3
|
33.8 score on a scale
Standard Deviation 8
|
|
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Post-Test
|
33.9 score on a scale
Standard Deviation 6.1
|
35.3 score on a scale
Standard Deviation 6
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=10 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
WHO Disability Assessment Schedule 2.0
Baseline
|
17.1 score on a scale
Standard Deviation 14.3
|
23.9 score on a scale
Standard Deviation 17.2
|
|
WHO Disability Assessment Schedule 2.0
Post-Test
|
16 score on a scale
Standard Deviation 14.7
|
22.2 score on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
The Gratitude Questionnaire (GQ-6)
Baseline
|
36.2 score on a scale
Standard Deviation 5.9
|
32.5 score on a scale
Standard Deviation 7.6
|
|
The Gratitude Questionnaire (GQ-6)
Post-Test
|
35.5 score on a scale
Standard Deviation 7.1
|
35.9 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
PROMIS Physical Function
Baseline
|
39.9 score on a scale
Standard Deviation 5.5
|
37.1 score on a scale
Standard Deviation 6.2
|
|
PROMIS Physical Function
Post-Test
|
43.4 score on a scale
Standard Deviation 9.6
|
38.2 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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.
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
PROMIS Emotional Support
Baseline
|
51.1 score on a scale
Standard Deviation 11.2
|
49.4 score on a scale
Standard Deviation 9.6
|
|
PROMIS Emotional Support
Post-Test
|
52.1 score on a scale
Standard Deviation 9.1
|
48.8 score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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.
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
T-Score for PROMIS Depression
Baseline
|
51.6 T-score
Standard Deviation 6.6
|
55.6 T-score
Standard Deviation 11.1
|
|
T-Score for PROMIS Depression
Post-Test
|
52.5 T-score
Standard Deviation 8.6
|
54.3 T-score
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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.
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
T-Score for PROMIS Anxiety
Baseline
|
51 score on a scale
Standard Deviation 10
|
52.9 score on a scale
Standard Deviation 10.1
|
|
T-Score for PROMIS Anxiety
Post-Test
|
47.9 score on a scale
Standard Deviation 10.2
|
53.7 score on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Baseline
|
9.4 score on a scale
Standard Deviation 6.8
|
11.6 score on a scale
Standard Deviation 9.4
|
|
Pain Catastrophizing Scale (PCS)
Post-Test
|
7.1 score on a scale
Standard Deviation 5.6
|
11 score on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
UCLA Loneliness Scale
Baseline
|
12.9 score on a scale
Standard Deviation 3.3
|
13.4 score on a scale
Standard Deviation 4.4
|
|
UCLA Loneliness Scale
Post-Test
|
12.6 score on a scale
Standard Deviation 5.2
|
13.3 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Pain Self Efficacy Questionnaire (PSEQ)
Baseline
|
38 score on a scale
Standard Deviation 14.2
|
35.5 score on a scale
Standard Deviation 18.9
|
|
Pain Self Efficacy Questionnaire (PSEQ)
Post-Test
|
42.9 score on a scale
Standard Deviation 14.5
|
38 score on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=8 Participants
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
n=9 Participants
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.
|
|---|---|---|
|
Tampa Kinesiophobia Scale
Baseline
|
31.9 score on a scale
Standard Deviation 6.2
|
37.6 score on a scale
Standard Deviation 8.9
|
|
Tampa Kinesiophobia Scale
Post-Test
|
31.2 score on a scale
Standard Deviation 13.5
|
35.8 score on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=8 Participants
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
n=11 Participants
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.
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|---|---|---|
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Chronic Pain Acceptance Questionnaire
Baseline
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30.1 score on a scale
Standard Deviation 8.7
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24.3 score on a scale
Standard Deviation 10.7
|
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Chronic Pain Acceptance Questionnaire
Post-Test
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31 score on a scale
Standard Deviation 8.2
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27.1 score on a scale
Standard Deviation 3.7
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SECONDARY outcome
Timeframe: 0 Weeks, 8 WeeksPopulation: Participant dropout as cited in consort.
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
Outcome measures
| Measure |
Active Brains
n=8 Participants
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
n=11 Participants
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.
|
|---|---|---|
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Self-Compassion Scale (SCS)
Baseline
|
45.6 score on a scale
Standard Deviation 7.9
|
44.4 score on a scale
Standard Deviation 8.5
|
|
Self-Compassion Scale (SCS)
Post-Test
|
43.2 score on a scale
Standard Deviation 7.4
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43.6 score on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 0 weeks, 8 weeksPopulation: Participant dropout as cited in consort.
Participants wore a ActiGraph accelerometer around their waist for 8 days to measure their daily average step count.
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
ActiGraph Average Steps
Post-Test
|
4283.8 steps per day
Standard Deviation 1905.7
|
2604.4 steps per day
Standard Deviation 1912.8
|
|
ActiGraph Average Steps
Baseline
|
3643.1 steps per day
Standard Deviation 1679.9
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3195.3 steps per day
Standard Deviation 1975.7
|
SECONDARY outcome
Timeframe: 0 weeks, 8 weeksPopulation: Participant dropout as cited in consort.
The Six-Minute Walk Test (6MWT) measures the distances participants can walk at an accelerated pace in meters over a 6-minute span.
Outcome measures
| Measure |
Active Brains
n=9 Participants
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
n=11 Participants
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.
|
|---|---|---|
|
Six-Minute Walk Test (6MWT)
Baseline
|
407.6 meters per 6 minutes
Standard Deviation 110.2
|
415.6 meters per 6 minutes
Standard Deviation 123.1
|
|
Six-Minute Walk Test (6MWT)
Post-Test
|
426.6 meters per 6 minutes
Standard Deviation 147.6
|
435.2 meters per 6 minutes
Standard Deviation 101.6
|
Adverse Events
Active Brains
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Brains 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ana-Maria Vranceanu
Center for Health Outcomes and Interdisciplinary Research, Department of Psychiatry, Massachusetts General Hospital
Phone: (617) 724-3953
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place