Behavioral Interventions to Prevent or Delay Dementia

Comparative Effectiveness of Behavioral Interventions to Prevent or Delay Dementia (CEBIPODD)

This study will compare the effectiveness of different combinations of 5 types of behavioral interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g. quality of life, cognition, function, mood) matter most to people at risk for dementia and their care partners. The results of this study have the potential to direct patients, families, and health care providers as to which combinations of behavioral interventions provide the greatest potential impact on which dementia prevention outcomes. Greater use of behavioral strategies that are targeted to the outcomes of most important to the patient will likely improve patient compliance and treatment adherence. This, in turn, can lessen the need for medication, health care, and long term care utilization.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Memory Disorders; Memory Impairment; Impaired Cognition; Mild Dementia; Mild Cognitive Disorder; Amnestic Disorder; Dementia and Amnestic Conditions; Poor Short-term Memory
• Intervention / Treatment: Behavioral: Cognitive Rehabilitation; Behavioral: Computer Brain Fitness Training; Behavioral: Support Group (patient and partner); Behavioral: Wellness Education; Behavioral: Physical Exercise

Detailed Description

Traditional randomized controlled trials (RCTs) can be thought of as 'additive' trials where randomization leads to the addition of treatments beyond placebo. Participants are confronted with the probability of receiving placebo (no treatment). This leads many potential participants to not consent or to withdraw if they believe they are receiving no treatment. In contrast, the proposed trial will be 'subtractive'. This innovative approach to randomization will involve suppression of just 1 of the 5 treatment components. Thus, all participants will receive at least 80% of the menu of interventions offered in this trial.

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A candidate for the HABIT program with a diagnosis of amnestic MCI (confirmed at eligibility visit by a Clinical Dementia Rating (CDR) scale of 0.5).

A cognitively normal care partner who has at least twice-weekly contact with the participant.

Either not taking or stable on memory medicine(s) (e.g. donepezil) for at least 3 months.

Fluent in English. (Expanding the program to communities of Spanish- speakers will be a high priority in subsequent dissemination work).

Exclusion Criteria:

Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.

Medically unable to participate in all arms by virtue of visual or auditory impairments or non-ambulatory status.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No Cognitive Rehabilitation; Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise.	Behavioral: Computer Brain Fitness Training; Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program and will be encouraged to maintain 250 minutes of computerized brain training per week for 18 months post program. Each participant's adherence and progress will be tracked through the clinician portal provided by Posit Science both during HABIT and for 18 months post-program.; Other Names: Brain Fitness; Behavioral: Support Group (patient and partner); Patient: The patient support group will meet for 45-60 minutes daily. It will use the LifeBio Memory Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.; Behavioral: Wellness Education; The education component will involve daily 60-minute group sessions with topics including Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition and Exercise, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.; Behavioral: Physical Exercise; The HABIT physical exercise intervention is intended to initiate and sustain a schedule rather than a type of physical activity. HABIT will provide a customized DVD as a supplement for continued use and practice after the program to those that opt to continue yoga. Will use an activity log completed by the partner to track activity level of the participants during the 18 month follow-up period.; Other Names: Yoga
Experimental: No Computer Brain Fitness Training; Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise	Behavioral: Cognitive Rehabilitation; Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here. Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual.; Other Names: Memory Compensation Training; Memory Support System; Behavioral: Support Group (patient and partner); Patient: The patient support group will meet for 45-60 minutes daily. It will use the LifeBio Memory Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.; Behavioral: Wellness Education; The education component will involve daily 60-minute group sessions with topics including Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition and Exercise, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.; Behavioral: Physical Exercise; The HABIT physical exercise intervention is intended to initiate and sustain a schedule rather than a type of physical activity. HABIT will provide a customized DVD as a supplement for continued use and practice after the program to those that opt to continue yoga. Will use an activity log completed by the partner to track activity level of the participants during the 18 month follow-up period.; Other Names: Yoga
Experimental: No Support Group; Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise	Behavioral: Cognitive Rehabilitation; Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here. Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual.; Other Names: Memory Compensation Training; Memory Support System; Behavioral: Computer Brain Fitness Training; Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program and will be encouraged to maintain 250 minutes of computerized brain training per week for 18 months post program. Each participant's adherence and progress will be tracked through the clinician portal provided by Posit Science both during HABIT and for 18 months post-program.; Other Names: Brain Fitness; Behavioral: Wellness Education; The education component will involve daily 60-minute group sessions with topics including Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition and Exercise, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.; Behavioral: Physical Exercise; The HABIT physical exercise intervention is intended to initiate and sustain a schedule rather than a type of physical activity. HABIT will provide a customized DVD as a supplement for continued use and practice after the program to those that opt to continue yoga. Will use an activity log completed by the partner to track activity level of the participants during the 18 month follow-up period.; Other Names: Yoga
Experimental: No Wellness Education; Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise	Behavioral: Cognitive Rehabilitation; Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here. Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual.; Other Names: Memory Compensation Training; Memory Support System; Behavioral: Computer Brain Fitness Training; Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program and will be encouraged to maintain 250 minutes of computerized brain training per week for 18 months post program. Each participant's adherence and progress will be tracked through the clinician portal provided by Posit Science both during HABIT and for 18 months post-program.; Other Names: Brain Fitness; Behavioral: Support Group (patient and partner); Patient: The patient support group will meet for 45-60 minutes daily. It will use the LifeBio Memory Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.; Behavioral: Physical Exercise; The HABIT physical exercise intervention is intended to initiate and sustain a schedule rather than a type of physical activity. HABIT will provide a customized DVD as a supplement for continued use and practice after the program to those that opt to continue yoga. Will use an activity log completed by the partner to track activity level of the participants during the 18 month follow-up period.; Other Names: Yoga
Experimental: No Physical Exercise; Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education	Behavioral: Cognitive Rehabilitation; Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here. Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual.; Other Names: Memory Compensation Training; Memory Support System; Behavioral: Computer Brain Fitness Training; Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program and will be encouraged to maintain 250 minutes of computerized brain training per week for 18 months post program. Each participant's adherence and progress will be tracked through the clinician portal provided by Posit Science both during HABIT and for 18 months post-program.; Other Names: Brain Fitness; Behavioral: Support Group (patient and partner); Patient: The patient support group will meet for 45-60 minutes daily. It will use the LifeBio Memory Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.; Behavioral: Wellness Education; The education component will involve daily 60-minute group sessions with topics including Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition and Exercise, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in patient quality of life	quality of life measured by the QOL-AD scale	baseline to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement in patient memory based everyday functioning	measured by the Everyday Cognitive Functioning scale (ECOG)	baseline to 18 months
improvement in caregiver mood and sense of burden	measured by the Caregiver Burden questionnaire and the Center for Epidemiological Studies Depression scale (CESD)	baseline to 18 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Julie Fields, PhD, LP, Mayo Clinic

Publications and helpful links

General Publications

• Levy SA, Smith G, De Wit L, DeFeis B, Ying G, Amofa P, Locke D, Shandera-Ochsner A, McAlister C, Phatak V, Chandler M. Behavioral Interventions in Mild Cognitive Impairment (MCI): Lessons from a Multicomponent Program. Neurotherapeutics. 2022 Jan;19(1):117-131. doi: 10.1007/s13311-022-01225-8. Epub 2022 Apr 12.
• Chandler MJ, Locke DE, Crook JE, Fields JA, Ball CT, Phatak VS, Dean PM, Morris M, Smith GE. Comparative Effectiveness of Behavioral Interventions on Quality of Life for Older Adults With Mild Cognitive Impairment: A Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e193016. doi: 10.1001/jamanetworkopen.2019.3016.
• Smith G, Chandler M, Locke DE, Fields J, Phatak V, Crook J, Hanna S, Lunde A, Morris M, Graff-Radford M, Hughes CA, Lepore S, Cuc A, Caselli M, Hurst D, Wethe J, Francone A, Eilertsen J, Lucas P, Hoffman Snyder C, Kuang L, Becker M, Dean P, Diehl N, Lofquist M, Vanderhook S, Myles D, Cochran D. Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study. JMIR Res Protoc. 2017 Nov 27;6(11):e223. doi: 10.2196/resprot.8103.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Cognitive Rehabilitation; Behavioral Intervention; HABIT; Multi-Component Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Disease; Dementia; Alzheimer Disease; Cognitive Dysfunction; Cognition Disorders; Memory Disorders
• Other Study ID Numbers: 14-000885