Chronic PainNCT04044183
Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment or Memory Related Problems and Chronic Pain
A study testing Active Brains 1 and Active Brains 2 in people with Chronic Pain and Mild Cognitive Impairment, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Pain, Mild Cognitive Impairment, Older Adults
- What is being tested?
- Active Brains 1 and Active Brains 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Active Brains: Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment (MCI) or Memory Related Problems (MRP) and Chronic Pain
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.
Read the 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.
- Being tested
- Active Brains 1, Active Brains 2
- Keywords
- Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity, Memory Related Problems
- Medical subject headings
- Chronic Pain, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Brains 1Behavioural
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 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Brains | Experimental | 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. Receives: Behavioral: Active Brains 1; Behavioral: Active Brains 2 |
| Active Brains 2 | Placebo comparator | 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. Receives: Behavioral: Active Brains 1; Behavioral: Active Brains 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 Weeks
Secondary outcomes (27)
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
Measured: 0 Weeks, 8 Weeks
Proportion of Participants With Valid Adherence to Homework
Proportion of participants completing at least 5 out of 7 days of homework assigned throughout the study
Measured: 0 Weeks, 8 Weeks
Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills
Percentage of audio recordings, progress notes, and checklists that were completed with 100% of content delivered for each session
Measured: 0 Weeks, 8 Weeks
Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)
Percentage of questionnaires that were entirely missing in >25% of participants and/or had an internal reliability below .70
Measured: 0 Weeks, 8 Weeks
Proportion of Participants Using Rescue (Non-Narcotic) Analgesics
Single-item question on demographics form indicating whether participant used rescue (non-narcotic) analgesics at baseline
Measured: 0 Weeks
Proportion of Participants Using Narcotic Analgesics
Single-item question on demographics form indicating whether participant used narcotic analgesics at baseline
Measured: 0 Weeks
Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
Number of participants rating expectations and believed credibility for the program above and below the scale midpoint, with higher ratings indicating more belief that the program is logical and will help with the intended outcome
Measured: 0 Weeks
Montreal Cognitive Assessment (MoCA)
Assesses several cognitive domains and detection of mild cognitive impairment (MCI), with scores ranging from 0-30 and lower scores indicating greater cognitive decline
Measured: 0 Weeks, 8 Weeks
Godin Leisure-Time Exercise Questionnaire
Rate of participant's leisure time and physical activity levels by indicating how many days per week are spent doing the activity for more than 15 minutes. Scores range from 0-119, with higher scores indicating greater levels of activity.
Measured: 0 Weeks, 8 Weeks
Measure of Current Status (MOCS-A)
Rate of a participant's self-reported perceived stress self-management skills, with items ranging from 0-4 and a total score ranging from 0-52, and higher scores reflecting more usage of stress self-management skills
Measured: 0 Weeks, 8 Weeks
The Measurement of Everyday Cognition (eCog)
Rate of participant's cognitively mediated functional abilities, with items ranging from 1-5. Total scores are an average of the items (range = 1-5), with higher scores indicating greater cognitive decline.
Measured: 0 Weeks, 8 Weeks
Numerical Rating Scale
Rate of a participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being the worst possible pain
Measured: 0 Weeks, 8 Weeks
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Rate of a participant's broad conceptualization of mindfulness, items range from 1-4 and scores range from 12-48, with higher values reflecting higher levels of mindfulness
Measured: 0 Weeks, 8 Weeks
WHO Disability Assessment Schedule 2.0
Rate of a participant's health and disability, with items ranging from 0-4, total scores ranging from 0-100, and higher scores reflecting greater disability
Measured: 0 Weeks, 8 Weeks
The Gratitude Questionnaire (GQ-6)
Rate of a participant's proneness to experience gratitude in daily life, with items ranging from 1-7, total scores ranging from 6-24, and a higher score indicating greater amount of gratitude
Measured: 0 Weeks, 8 Weeks
PROMIS Physical Function
Rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4, and total scores ranging from 8-40, with a higher score reflecting greater physical function
Measured: 0 Weeks, 8 Weeks
PROMIS Emotional Support
Rate of a participant's perceived feelings of being cared and values for as an individual, with items ranging from 1-5. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher perceived social support.
Measured: 0 Weeks, 8 Weeks
T-Score for PROMIS Depression
Rate of a participant's depressive symptoms, with items ranging from 1-5. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher depression.
Measured: 0 Weeks, 8 Weeks
T-Score for PROMIS Anxiety
Rate of a participant's fear, anxious, hyper arousal, and somatic symptoms pertaining to arousal. Items are normed to T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating higher anxiety.
Measured: 0 Weeks, 8 Weeks
Pain Catastrophizing Scale (PCS)
Rate of a participant's pain experience, with items ranging from 0-4, and total scores ranging from 0-52, with higher scores indicating higher levels of pain catastrophizing
Measured: 0 Weeks, 8 Weeks
UCLA Loneliness Scale
Rate of a participant's feelings of loneliness and social isolation and items range from 0-3, with a higher score reflecting greater feelings of loneliness, with total scores ranging from 0-24
Measured: 0 Weeks, 8 Weeks
Pain Self Efficacy Questionnaire (PSEQ)
Rate of a participant's confidence to do various activities despite their pain, with items ranging from 0-6, and a higher score showing greater levels of confidence with pain self-efficacy, with total scores ranging from 0-60
Measured: 0 Weeks, 8 Weeks
Tampa Kinesiophobia Scale
Rate of a participant's fear of movement, with items ranging from 1-4, and a total scores ranging from 17-68, and higher scores indicating higher levels of fear of movement
Measured: 0 Weeks, 8 Weeks
Chronic Pain Acceptance Questionnaire
Rate of a participant's acceptance of chronic pain, with scores ranging from 0-6, with the total score ranging from 0-48, and higher scores indicating higher levels of acceptance of chronic pain
Measured: 0 Weeks, 8 Weeks
Self-Compassion Scale (SCS)
Rate of a participant's amount of self-compassion, with items ranging from 1-5, and total scores ranging from 12-60 and higher scores indicating higher levels of self-compassion
Measured: 0 Weeks, 8 Weeks
ActiGraph Average Steps
Participants wore a ActiGraph accelerometer around their waist for 8 days to measure their daily average step count.
Measured: 0 weeks, 8 weeks
Six-Minute Walk Test (6MWT)
The Six-Minute Walk Test (6MWT) measures the distances participants can walk at an accelerated pace in meters over a 6-minute span.
Measured: 0 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start15 Sep 2019
- Primary completion21 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044183
- Sponsor's protocol ID
- 2018P002152
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2019
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doorley JD, Mace RA, Popok PJ, Grunberg VA, Ragnhildstveit A, Vranceanu AM. Feasibility Randomized Controlled Trial of a Mind-Body Activity Program for Older Adults With Chronic Pain and Cognitive Decline: The Virtual "Active Brains" Study. Gerontologist. 2022 Aug 12;62(7):1082-1094. doi: 10.1093/geront/gnab135.
PubMed 34487167Mace RA, Doorley JD, Popok PJ, Vranceanu AM. Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study. JMIR Res Protoc. 2021 Jan 4;10(1):e25351. doi: 10.2196/25351.
PubMed 33208301
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Brains: Managing Pain and Cognitions in Older Adults With Mild Cognitive Impairment (MCI) or Memory Related Problems (MRP) and Chronic Pain
- ClinicalTrials.gov ID
- NCT04044183
- Acronym / sponsor ID
- 2018P002152
- Keywords
- Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity, Memory Related Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Posted 20 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Brains | Experimental | Behavioral: Active Brains 1, Behavioral: Active Brains 2Active 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 | Placebo comparator | Behavioral: Active Brains 1, Behavioral: Active Brains 2This 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 may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Brains 1Active 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. | Behavioural | Active Brains, Active Brains 2 |
| Active Brains 2This 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. | Behavioural | Active Brains, Active Brains 2 |
Primary outcome
Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint
Time frame: 8 Weeks
Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction
27 secondary outcomes
Proportion of Participants With Valid Digital Monitoring Device Wear
Time frame: 0 Weeks, 8 Weeks
Proportion of Participants With Valid Adherence to Homework
Time frame: 0 Weeks, 8 Weeks
Rate of Interventionist's Delivering the Programs by Following the Established Session Topics and Skills
Time frame: 0 Weeks, 8 Weeks
Percentage of Missing or Low Reliability Measures (Feasibility of Quantitative Measures)
Time frame: 0 Weeks, 8 Weeks
Proportion of Participants Using Rescue (Non-Narcotic) Analgesics
Time frame: 0 Weeks
Proportion of Participants Using Narcotic Analgesics
Time frame: 0 Weeks
Credibility and Expectancy Questionnaire (CEQ): Number of Participants With Scores Above and Below Scale Midpoint
Time frame: 0 Weeks
Montreal Cognitive Assessment (MoCA)
Time frame: 0 Weeks, 8 Weeks
Godin Leisure-Time Exercise Questionnaire
Time frame: 0 Weeks, 8 Weeks
Measure of Current Status (MOCS-A)
Time frame: 0 Weeks, 8 Weeks
The Measurement of Everyday Cognition (eCog)
Time frame: 0 Weeks, 8 Weeks
Numerical Rating Scale
Time frame: 0 Weeks, 8 Weeks
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R)
Time frame: 0 Weeks, 8 Weeks
WHO Disability Assessment Schedule 2.0
Time frame: 0 Weeks, 8 Weeks
The Gratitude Questionnaire (GQ-6)
Time frame: 0 Weeks, 8 Weeks
PROMIS Physical Function
Time frame: 0 Weeks, 8 Weeks
PROMIS Emotional Support
Time frame: 0 Weeks, 8 Weeks
T-Score for PROMIS Depression
Time frame: 0 Weeks, 8 Weeks
T-Score for PROMIS Anxiety
Time frame: 0 Weeks, 8 Weeks
Pain Catastrophizing Scale (PCS)
Time frame: 0 Weeks, 8 Weeks
UCLA Loneliness Scale
Time frame: 0 Weeks, 8 Weeks
Pain Self Efficacy Questionnaire (PSEQ)
Time frame: 0 Weeks, 8 Weeks
Tampa Kinesiophobia Scale
Time frame: 0 Weeks, 8 Weeks
Chronic Pain Acceptance Questionnaire
Time frame: 0 Weeks, 8 Weeks
Self-Compassion Scale (SCS)
Time frame: 0 Weeks, 8 Weeks
ActiGraph Average Steps
Time frame: 0 weeks, 8 weeks
Six-Minute Walk Test (6MWT)
Time frame: 0 weeks, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34487167Doorley JD, Mace RA, Popok PJ, Grunberg VA, Ragnhildstveit A, Vranceanu AM. Feasibility Randomized Controlled Trial of a Mind-Body Activity Program for Older Adults With Chronic Pain and Cognitive Decline: The Virtual "Active Brains" Study. Gerontologist. 2022 Aug 12;62(7):1082-1094. doi: 10.1093/geront/gnab135.
- Derived from this study: PubMed 33208301Mace RA, Doorley JD, Popok PJ, Vranceanu AM. Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study. JMIR Res Protoc. 2021 Jan 4;10(1):e25351. doi: 10.2196/25351.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Maria Vranceanu, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Brains 1 and Active Brains 2 in people with Chronic Pain and Mild Cognitive Impairment, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire 3-Item (CSQ-3): Number of Participants With Scores Above and Below Scale Midpoint (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04044183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.