Brain Health Program for Older Adults With Subjective Cognitive Decline

Mass General Brigham

Status: Completed

Conditions: Healthy Lifestyle; Risk Reduction Behavior; Memory Loss (Excluding Dementia)

Treatments: Behavioral: My Healthy Brain 1; Behavioral: My Healthy Brain 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05934136

2023P001770

Details and patient eligibility

About

The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.

Full description

The investigators aim to promote brain health by reducing lifestyle risk factors for dementia in older adults with subjective cognitive decline (SCD). This study is a pilot randomized control trial (RCT) comparing two virtual lifestyle programs, My Healthy Brain 1 and My Healthy Brain 2. Eligible older adults include: age ≥ 60, self-reported worry about changes in memory or thinking, and risk factors for dementia (determined by the Cardiovascular Risk Factors, Aging, and Incidence of Dementia score ≥ 6). Participants will be randomized to one of two groups (My Healthy Brain 1 or My Healthy Brain 2) and will complete 8 weekly 90-minute sessions via Zoom delivered by a clinical psychologist. Each session will focus on a different topic relevant to brain health (e.g. physical activity, sleep, etc.). The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs. The investigators will also explore improvements in cognition, lifestyle behaviors (physical activity, sleep, nutrition, alcohol and tobacco use, social functioning), depression, anxiety, and mindfulness assessed at baseline, post-intervention, and 6 month follow-up. All participants will wear a watch to monitor changes in lifestyle during the program.

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Concerns about memory or thinking (subjective cognitive decline, SCD) aged 60 or older
• Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) ≥ 6
• Telephone Interview for Cognitive Status-41 ≥ 31
• Functional Assessment Questionnaire < 9
• English fluency/literacy
• Ability and willingness to participate via live video
• No self-reported safety issues with initiating lifestyle changes during the study

Exclusion criteria

• Mild cognitive impairment, dementia, or neurodegenerative disease
• Psychotropic medications (e.g., antidepressant) change in the last 3 months
• Psychosis, uncontrolled bipolar disorder or substance dependence; schizophrenia or schizoaffective disorder
• Current self-report of suicidal ideation
• Serious medical illness expected to worsen in 6 months (e.g., cancer)
• Use of digital monitoring device (e.g., Fitbit) in the last 3 moths AND unwillingness to stop using personal digital monitoring device for duration of program
• Mindfulness or mind-body practice (> 45 min/wk) focused on lifestyle, cognitive-behavioral therapy in < 3 months, or participation in a lifestyle prevention program (ex: diabetes prevention) in < 3 months
• Average daily step count > 5,000 steps
• More than 30 minutes of exercise daily

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

My Healthy Brain 1

Experimental group

Description:

My Healthy Brain 1 is an 8-week group program delivered via 90-minute Zoom meetings led by a clinical psychologist. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain 1 participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain 1 participants wear an activity watch to monitor lifestyle changes during the program.

Treatment:

Behavioral: My Healthy Brain 1

My Healthy Brain 2

Active Comparator group

Description:

My Healthy Brain 2 condition controls for the effect of time spent and support/feedback from the group and interventionist. Participants in My Healthy Brain 2 will receive education on lifestyle, brain health, and cognitive decline symptoms in addition to usual care as determined by their medical team. Each weekly session will focus on a different topic: 1) lifestyle and brain health, 2) physical activity, 3) sleep, 4) nutrition, 5) medical adherence, 6) cognitive health, 7) social support, and 8) a program overview. My Healthy Brain 2 is conducted in the same format as My Healthy Brain 1 (8 weekly Zoom sessions, 90 minutes each), but does not include behavior change strategies. My Healthy Brain 2 participants wear an activity watch to monitor lifestyle changes during the program.

Treatment:

Behavioral: My Healthy Brain 2