Chronic PainNCT05373745

Managing Pain and Cognitions in Older Adults With Early Cognitive Decline 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 267 participants
Where: 1 siteUnited States
Study dates: 20 Jun 2022to 1 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

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 outpatients, age 60 years or older
Have nonmalignant chronic pain for more than 3 months
Reports early cognitive decline (subjective or objective)
Telephone Interview for Cognitive Status-30 score greater than or equal to 17
Functional Activities Questionnaire score less than 9
Able to perform a 6-minute walk test at an accelerated pace

Show all 10Show fewer

English fluency/literacy
Willingness and ability to participate and use an ActiGraph watch and smartphone app to view and sync the step count and sleep data
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 and no self-reported concerns about physical functioning on the revised Physical Activity Readiness Questionnaire (PAR-Q; score 0)

Who cannot join

Diagnosed with dementia or neurodegenerative disease
Diagnosed with medical illness expected to worsen in the next 6 months
Diagnosed with serious untreated mental illness (i.e., schizophrenia) or untreated substance use disorder
Current suicidal ideation reported on self-report
Engaging in regular mindfulness practice > 45 min/week or has completed a course of cognitive behavioral therapy in the past 3 months
Regular use of a digital-monitoring device
Engagement in regular intensive physical exercise for >30 minute daily

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study

The investigators aim to conduct a fully powered randomized controlled trial to compare the efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how each program may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors. Both programs will be delivered virtually (Zoom).

Read the detailed description

The investigators aim to conduct a fully powered randomized controlled trial to establish efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how the two programs may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors, and type of early cognitive decline. Both programs will be delivered virtually (Zoom).

Each group meets for eight, 90 minutes sessions over the secure Zoom platform. Each group has 5-8 participants. Participants receive a treatment manual. There are 3 assessment points: baseline, post program and 6-month follow-up. Assessments involve self-report questionnaires, a walk test and a neuropsychological evaluation.

Conditions: Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity
Being tested: Active Brains 1, Active Brains 2
Keywords: Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity, Memory Related Problems, Early Cognitive Decline
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 1 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 teach skills and strategies to manage early cognitive concerns and chronic pain. 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 wrist-worn digital monitoring device (ActiGraph) 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. Active Brains 2 addresses population-specific challenges of chronic pain and early cognitive decline 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 Active Brains 2 program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The Active Brains 2 is conducted in the same format as Active Brains 1, but participants are not taught the mind-body, walking or cognitive-behavioral skills. Active Brains 2 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

Study groups in NCT05373745
Study group	Role	What they receive
Active Brains 1	Experimental	Active Brains 1 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 teach skills and strategies to manage early cognitive concerns and chronic pain. 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 wrist-worn digital monitoring device (ActiGraph) for recording of physical activity. Receives: Behavioral: Active Brains 1
Active Brains 2	Placebo comparator	This active comparison condition controls for the effect of time spent, group member support/feedback and interventionist support/feedback. Active Brains 2 addresses population-specific challenges of chronic pain and early cognitive decline 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 Active Brains 2 program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The Active Brains 2 is conducted in the same format as Active Brains 1, but participants are not taught the mind-body, walking or cognitive-behavioral skills. Active Brains 2 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity. Receives: Behavioral: Active Brains 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in PROMIS Physical Function
Change in rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4. Higher T scores indicate greater physical function.
Measured: 0 Weeks, 8 Weeks, 6 Months
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer
Measures the change in steps during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up.
Measured: 0 Weeks, 8 Weeks, 6 Months
Change in six-minute walk test (6MWT)
Assesses distance walked in 6 minutes.
Measured: 0 Weeks, 8 Weeks, 6 Months

Secondary outcomes (5)

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
A comprehensive test of five cognitive domains (immediate memory, visuospatial/constructional, language, attention, and delayed memory) and global cognition.
Measured: 0 Weeks, 8 Weeks, 6 Months
Everyday Cognition Scale (eCog-12)
Rate of participant's cognitively mediated functional abilities, with items ranging from 1-5. Scores are calculated by averaging the 12 items, and range from 1-5, with higher scores indicating greater cognitive decline.
Measured: 0 Weeks, 8 Weeks, 6 Months
PROMIS Depression
Rate of a participant's negative mood, social cognition and views of self, with items ranging from 1-5. Higher T scores indicate higher levels of depression.
Measured: 0 Weeks, 8 Weeks, 6 Months
PROMIS Anxiety
Rate of a participant's fear, anxious, hyperarousal and somatic symptoms pertaining to arousal, with items ranging from 1-5. Higher T scores indicate higher levels of anxiety.
Measured: 0 Weeks, 8 Weeks, 6 Months
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 worst possible pain.
Measured: 0 Weeks, 8 Weeks, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 20221 Jun 2026

First posted13 May 2022
Study start20 Jun 2022
Primary completion31 Dec 2025
Study completion1 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)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: 267 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05373745
Sponsor's protocol ID: 2021P00281
Status last verified: Jun 2026
First submitted: 15 Apr 2022
Last updated: 12 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mace 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
Mace RA, Gates MV, Popok PJ, Kulich R, Quiroz YT, Vranceanu AM. Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Nov 15;61(8):1326-1337. doi: 10.1093/geront/gnaa179.
PubMed 33159516
Mace RA, Gates MV, Bullard B, Lester EG, Silverman IH, Quiroz YT, Vranceanu AM. Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Apr 3;61(3):449-459. doi: 10.1093/geront/gnaa084.
PubMed 32601670
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 34487167
Vranceanu AM, Choukas NR, Rochon EA, Duarte B, Pietrzykowski MO, McDermott K, Hooker JE, Kulich R, Quiroz YT, Parker RA, Macklin EA, Ritchie C; Active Brains Project; Mace RA. Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial. JMIR Res Protoc. 2023 Sep 28;12:e47319. doi: 10.2196/47319.
PubMed 37768713

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults; The Active Brains Study
ClinicalTrials.gov ID: NCT05373745
Acronym / sponsor ID: 2021P00281
Conditions: Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity
Keywords: Chronic Pain, Mild Cognitive Impairment, Older Adults, Physical Activity, Memory Related Problems, Early Cognitive Decline
Study type: Interventional
Recruitment status: Completed
Enrolment: 267 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 20 Jun 2022 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 1 Jun 2026 (actual)
First posted: 13 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Active Brains 1	Experimental	Behavioral: Active Brains 1Active Brains 1 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 teach skills and strategies to manage early cognitive concerns and chronic pain. 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 wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.
Active Brains 2	Placebo comparator	Behavioral: Active Brains 2This active comparison condition controls for the effect of time spent, group member support/feedback and interventionist support/feedback. Active Brains 2 addresses population-specific challenges of chronic pain and early cognitive decline 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 Active Brains 2 program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The Active Brains 2 is conducted in the same format as Active Brains 1, but participants are not taught the mind-body, walking or cognitive-behavioral skills. Active Brains 2 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male and female outpatients, age 60 years or older
Have nonmalignant chronic pain for more than 3 months
Reports early cognitive decline (subjective or objective)
Telephone Interview for Cognitive Status-30 score greater than or equal to 17
Functional Activities Questionnaire score less than 9

Key exclusion criteria (7 listed)

Diagnosed with dementia or neurodegenerative disease
Diagnosed with medical illness expected to worsen in the next 6 months
Diagnosed with serious untreated mental illness (i.e., schizophrenia) or untreated substance use disorder
Current suicidal ideation reported on self-report
Engaging in regular mindfulness practice > 45 min/week or has completed a course of cognitive behavioral therapy in the past 3 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 1 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 teach skills and strategies to manage early cognitive concerns and chronic pain. 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 wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.	Behavioural	Active Brains 1
Active Brains 2This active comparison condition controls for the effect of time spent, group member support/feedback and interventionist support/feedback. Active Brains 2 addresses population-specific challenges of chronic pain and early cognitive decline 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 Active Brains 2 program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The Active Brains 2 is conducted in the same format as Active Brains 1, but participants are not taught the mind-body, walking or cognitive-behavioral skills. Active Brains 2 uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.	Behavioural	Active Brains 2

Primary outcome

Change in PROMIS Physical Function
Time frame: 0 Weeks, 8 Weeks, 6 Months
Change in rate of a participant's capability rather than performance of physical activities, with items ranging from 1-4. Higher T scores indicate greater physical function.
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer
Time frame: 0 Weeks, 8 Weeks, 6 Months
Measures the change in steps during the 7 days preceding baseline assessment, throughout the intervention period, and 7 days preceding 6-month follow-up.
Change in six-minute walk test (6MWT)
Time frame: 0 Weeks, 8 Weeks, 6 Months
Assesses distance walked in 6 minutes.

5 secondary outcomes

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 0 Weeks, 8 Weeks, 6 Months
Everyday Cognition Scale (eCog-12)
Time frame: 0 Weeks, 8 Weeks, 6 Months
PROMIS Depression
Time frame: 0 Weeks, 8 Weeks, 6 Months
PROMIS Anxiety
Time frame: 0 Weeks, 8 Weeks, 6 Months
Numerical Rating Scale
Time frame: 0 Weeks, 8 Weeks, 6 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Background: 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.
Background: PubMed 33159516Mace RA, Gates MV, Popok PJ, Kulich R, Quiroz YT, Vranceanu AM. Feasibility Trial of a Mind-Body Activity Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Nov 15;61(8):1326-1337. doi: 10.1093/geront/gnaa179.
Background: PubMed 32601670Mace RA, Gates MV, Bullard B, Lester EG, Silverman IH, Quiroz YT, Vranceanu AM. Development of a Novel Mind-Body Activity and Pain Management Program for Older Adults With Cognitive Decline. Gerontologist. 2021 Apr 3;61(3):449-459. doi: 10.1093/geront/gnaa084.
Background: 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 37768713Vranceanu AM, Choukas NR, Rochon EA, Duarte B, Pietrzykowski MO, McDermott K, Hooker JE, Kulich R, Quiroz YT, Parker RA, Macklin EA, Ritchie C; Active Brains Project; Mace RA. Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial. JMIR Res Protoc. 2023 Sep 28;12:e47319. doi: 10.2196/47319.
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 10 inclusion and 7 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 12 Jun 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in PROMIS Physical Function (time frame: 0 Weeks, 8 Weeks, 6 Months). The study lists 3 primary outcomes in all. 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 NCT05373745, which also lists 5 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 12 Jun 2026.