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Behavioral Intervention

My Healthy Brain 1 for Amnesia

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 weeks, 8 weeks, 6 months

Awards & highlights

Study Summary

This trial will compare two brain health programs for older adults who have memory problems and lifestyle factors that increase their risk for dementia. The main goal of the study is to see how well the programs work and

Who is the study for?

This trial is for older adults who feel their memory or thinking skills are slipping (subjective cognitive decline), have a risk score for dementia of 6 or higher, can communicate in English, and can join live video sessions. They must be cleared by a doctor to participate and should not have significant functional impairments.Check my eligibility

What is being tested?

The study compares two 'My Healthy Brain' programs designed to support brain health and possibly reduce the risk of dementia. The goal is to evaluate how believable, expected, doable, acceptable, suitable these programs are and how satisfied participants are with them.See study design

What are the potential side effects?

Since this trial involves lifestyle interventions rather than medications, side effects may include discomfort from changes in routine but no medical side effects like those seen with drugs.

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

Client Satisfaction Questionnaire

Credibility and Expectancy Questionnaire

Modified Patient Global Impression of Change at 8 weeks

+8 more

Secondary outcome measures

CDC Other Tobacco Product Use Questions

Change in Step Count

Change in Total Sleep Time

+7 more

Other outcome measures

Applied Mindfulness Process Scale

Cognitive Control and Flexibility Questionnaire

Emotion Regulation Questionnaire

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: My Healthy Brain 1Experimental Treatment1 Intervention

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.

Group II: My Healthy Brain 2Active Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,934 Previous Clinical Trials

13,198,531 Total Patients Enrolled

Frequently Asked Questions

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

What is the total number of individuals currently under research in this clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this investigation is actively seeking eligible participants. The initial posting of this study was on January 16th, 2024, with the most recent update made on January 22nd, 2024. To complete the study objectives, a total of 50 patients will be recruited from a single site."

Answered by AI

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, the details found on clinicaltrials.gov affirm that this trial is actively seeking participants. The trial was posted for the first time on January 16th, 2024 and underwent its most recent update on January 22nd, 2024. The study aims to enroll a total of 50 individuals at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain Health Program for Older Adults With Subjective Cognitive Decline

Ryan A., Mace, PHD 2024. "Brain Health Program for Older Adults With Subjective Cognitive Decline". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05934136.