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Active Brains Programs for Cognitive Impairment and Chronic Pain in Aging Adults

N/A

Recruiting

Led By Ana-Maria Vranceanu, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female outpatients, age 60 years or older

Have nonmalignant chronic pain for more than 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 weeks, 8 weeks, 6 months

Awards & highlights

Study Summary

This trial will compare the efficacy of two symptom management programs, Active Brains 1 and 2, for older adults with early cognitive decline and chronic pain. The programs will be delivered virtually, and investigators will assess how each program may help in improving multimodal physical, cognitive and emotional function.

Who is the study for?

This trial is for adults aged 60 or older with mild cognitive issues and chronic pain, who can use a smartphone app and fitness watch. They should be able to walk briskly for six minutes, not have dementia or worsening medical conditions, and either be off certain medications for two weeks or on a stable dose.Check my eligibility

What is being tested?

The study compares two virtual programs called Active Brains 1 & 2 designed to manage symptoms in aging individuals with early cognitive decline and chronic pain. It will evaluate improvements in physical, cognitive, and emotional functions over six months.See study design

What are the potential side effects?

Since the interventions are non-pharmacological programs focusing on symptom management through virtual means like Zoom sessions, significant side effects are not anticipated as commonly seen with medication trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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I have had chronic pain not caused by cancer for over 3 months.

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I can walk quickly for 6 minutes without stopping.

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I haven't taken any mental health or pain meds for 2 weeks, or I've been on a stable dose for 6 weeks.

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I am mostly independent in my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 weeks, 8 weeks, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 weeks, 8 weeks, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks, 8 weeks, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PROMIS Physical Function

Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer

Change in six-minute walk test (6MWT)

Secondary outcome measures

Everyday Cognition Scale (eCog-12)

Numerical Rating Scale

PROMIS Anxiety

+2 more

Other outcome measures

Change in PROMIS Pain Interference - Short Form 6b V1.0

Global Cognitive and Social Engagement

Gratitude Questionnaire

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Brains 1Experimental Treatment1 Intervention

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.

Group II: Active Brains 2Placebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Brains 1

2019

N/A

~30

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,095 Total Patients Enrolled

30 Trials studying Chronic Pain

4,753 Patients Enrolled for Chronic Pain

Ana-Maria Vranceanu, PhDPrincipal InvestigatorMassachusetts General Hospital

20 Previous Clinical Trials

1,826 Total Patients Enrolled

5 Trials studying Chronic Pain

424 Patients Enrolled for Chronic Pain

Media Library

Active Brains 1 Clinical Trial Eligibility Overview. Trial Name: NCT05373745 — N/A

Chronic Pain Research Study Groups: Active Brains 1, Active Brains 2

Chronic Pain Clinical Trial 2023: Active Brains 1 Highlights & Side Effects. Trial Name: NCT05373745 — N/A

Active Brains 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05373745 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have enrolled in this experiment thus far?

"Correct. According to clinicaltrials.gov, this research endeavour is currently in the process of enrolling patients since it was initially posted on June 20th 2022 and recently updated on June 25th 2022. It requires 260 participants from a single medical site."

Answered by AI

What are the prime motivations behind this medical study?

"The researchers of this clinical trial will measure the principal outcome, Change in six-minute walk test (6MWT), over a period of 0 Weeks, 8 Weeks and 6 Months. Secondary outcomes include Montreal Cognitive Assessment (MoCA; audiovisual version) for detecting mild cognitive impairment (MCI); Everyday Cognition Scale (eCog-12) to rate participants' cognitively mediated functions; Numerical Rating Scale for assessing patients’ pain with rest and movement on a Likert scale from zero to ten."

Answered by AI

Are recruitment efforts still underway for this research project?

"Affirmative. The trial's listing on clinicaltrials.gov shows that recruitment is still active, having first been posted on June 20th 2022 and last updated the 25th of that same month. At present it seeks to enroll 260 individuals at a single location."

Answered by AI