Mindfulness-Based Cognitive Therapy vs Active Living for Mild Cognitive Impairment
(HABIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two programs to assess their effectiveness in helping Black older adults with early memory issues and chronic pain. One program, MBCT+w, combines mindfulness and walking to teach skills for managing these challenges. The other, ALED (Active Living Every Day), focuses on increasing physical activity without the mindfulness component. The goal is to determine which program better improves physical, mental, and emotional health over time. This trial suits Black adults over 50 who have experienced early memory problems and chronic pain for more than three months. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance health outcomes for Black older adults.
Will I have to stop taking my current medications?
You don't have to stop your current medications if you have been on a stable dose for at least 6 weeks and are willing to keep it stable. If not, you need to be off psychotropic or pain medications for at least 2 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) is generally well-tolerated. Studies indicate that mindfulness techniques can reduce feelings of depression, anxiety, and stress. These techniques are also considered acceptable and trustworthy for individuals with mild cognitive impairment (MCI) and similar conditions.
While specific studies on the safety of the Active Living Every Day (ALED) program are lacking, ALED aims to change behavior to promote physical activity, which is typically safe and beneficial for most people. Both programs incorporate a wrist-worn device to track physical activity, adding a tech element without any known safety issues. Overall, based on current evidence, both MBCT+w and ALED appear to be safe options.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for mild cognitive impairment because they offer holistic and accessible strategies to enhance cognitive function. Mindfulness-Based Cognitive Therapy with Walking (MBCT+w) combines relaxation techniques, cognitive-behavioral training, and physical activity monitoring to address cognitive concerns and chronic pain, providing a comprehensive mind-body approach. On the other hand, Active Living Every Day (ALED) emphasizes behavior change, helping participants overcome barriers to physical activity through goal setting and group discussions. Both programs utilize a wrist-worn digital device for tracking activity, making them innovative and user-friendly compared to traditional pharmacological treatments.
What evidence suggests that this trial's treatments could be effective for mild cognitive impairment?
In this trial, participants will be assigned to one of two treatment arms. One treatment under study is Mindfulness-Based Cognitive Therapy with Walking (MBCT+w). Research has shown that MBCT+w can enhance mental and emotional health. Studies have found that mindfulness practices can improve focus and even lead to brain changes in people with mild memory problems. Other research highlights that MBCT can effectively reduce feelings of depression, anxiety, and stress. This method also helps older adults manage stress and depression. Overall, MBCT+w appears promising for those facing early memory issues and ongoing pain.
In contrast, the other treatment arm in this trial is Active Living Every Day (ALED), which helps people become more active by addressing obstacles to exercise. Although specific studies on ALED may be fewer, similar programs have successfully increased physical activity and enhanced overall well-being. Both programs aim to improve physical and mental health but use different approaches to achieve this.13678Who Is on the Research Team?
Olivia Okereke, MD, MS
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants engage in either MBCT+w or ALED programs to manage chronic pain and cognitive decline
Follow-up
Participants are monitored for maintenance of improvements in physical, cognitive, and emotional function
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
Mindfulness-Based Cognitive Therapy in Clinical Practice
Results: Evidence from the studies highlights the effectiveness of MBCT in reducing symptoms of depression, anxiety, and stress. MBCT was also shown to enhance ...
Mindfulness intervention for mild cognitive impairment led ...
Mindfulness intervention for mild cognitive impairment led to attention-related improvements and neuroplastic changes: Results from a 9-month randomized control ...
Effectiveness of mindfulness‐based interventions on ...
This systematic review aimed to assess the effectiveness of MBIs on mental and cognitive outcomes including, anxiety, depression, attention, ...
4.
bmccomplementmedtherapies.biomedcentral.com
bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-025-04781-6Effectiveness of an age-modified mindfulness-based cognitive ...
Age-modified MBCT is beneficial in managing depressive and stress symptoms and in improving mindful non-reactivity among older adults at risk for depression.
A Systematic Review of Mindfulness-Based Interventions ...
The aim of this article was to systematically review the quality and efficacy of the current evidence for mindfulness-based interventions ...
Meditation for subjective cognitive decline, mild cognitive ...
This meta-analysis suggests that meditation is an effective adjunct therapy for improving global cognitive performance, sleep quality, and health status in ...
Impact of mind-body interventions in older adults with mild ...
Mind-body interventions have been associated with a range of positive outcomes in older adults with mild cognitive impairment (MCI). The aim of the present ...
Effects of Mindfulness Training and Exercise on Cognitive ...
The findings do not support the use of mindfulness training, exercise, or a combination of both for significantly improving cognitive function in older adults.
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