Mindfulness-Based Cognitive Therapy vs Active Living for Mild Cognitive Impairment

(HABIT Trial)

Overseen By Adjoa Acquaah, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropics, Pain medications

Disqualifiers: Dementia, Neurodegenerative disease, Serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 8-12 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators aim to conduct a randomized controlled trial to compare two symptom-management programs for Black older adults with early cognitive decline (self-reported confirmed by testing) and chronic pain. The programs are Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED). The investigators will assess how each program may help in improving physical, cognitive, and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through a 6-month follow-up.

Research Team

Olivia Okereke, MD, MS

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for Black adults aged 50 or older who have early cognitive decline and chronic pain. Participants must be cleared by a doctor, not on new psychotropic or pain meds (or stable on current ones), and able to engage in physical activity without concerns.

Inclusion Criteria

English fluency/literacy

I am mostly independent in my daily activities.

Reports early cognitive decline (subjective and objective)

Exclusion Criteria

I regularly use methods like exercise or meditation to manage pain.

Diagnosed with serious mental illness or substance abuse

Current suicidal ideation on self-report

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either MBCT+w or ALED programs to manage chronic pain and cognitive decline

8-12 weeks

8 sessions (90 minutes each) for MBCT+w, 12 sessions (60 minutes each) for ALED

Follow-up

Participants are monitored for maintenance of improvements in physical, cognitive, and emotional function

6 months

Assessments at baseline, post program, and 6-month follow-up

Treatment Details

Interventions

• ALED
• MBCT+w

Trial Overview The study compares two programs: Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) and Active Living Every Day (ALED). It will evaluate how these interventions affect physical, cognitive, and emotional functions over time, including a follow-up after six months.

Participant Groups

Group I: Mindfulness-Based Cognitive Therapy With Walking (MBCT+w) Experimental Treatment 1 Intervention

MBCT+w uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions and weekly practice assignments (homework). The MBCT+w sessions teach skills and strategies to manage early cognitive concerns and chronic pain. The format is an 8-week program with 90-minute weekly meetings that will focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. MBCT+w uses a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

Group II: Active Living Every Day (ALED) Active Control 1 Intervention

ALED is a behavior change program. ALED offers different options to traditional exercise program to help participants overcome barriers to physical activity and increase their physical activity. The format is a 12-week program with 60-minute sessions that include a short lecture and group discussions to help participants set goals, decrease barriers to exercise, and find an activity they enjoy. The ALED program is conducted in the same format as MBCT+w, but participants are not taught the mind-body, walking or cognitive-behavioral skills. ALED will also use a wrist-worn digital monitoring device (ActiGraph) for recording of physical activity.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+