Mild Cognitive ImpairmentNCT02265757
Behavioral Interventions to Prevent or Delay Dementia
A study testing Cognitive Rehabilitation, Computer Brain Fitness Training and Support Group (patient and partner) in people with Mild Cognitive Impairment and Memory Disorders, run by Mayo Clinic at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Memory Disorders, Mild Dementia
- What is being tested?
- Cognitive Rehabilitation, Computer Brain Fitness Training and Support Group (patient and partner)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2014to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Memory Disorders, Mild Dementia, Impaired Cognition, Mild Cognitive Disorder, Amnestic Disorder
- Being tested
- Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group (patient and partner), Wellness Education, Physical Exercise
- Keywords
- Behavioral Intervention, Mild Cognitive Impairment, HABIT, Cognitive Rehabilitation, Multi-Component Intervention
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders, Cognition Disorders, Neurocognitive Disorders, Dementia, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationBehavioural
Also called Memory Compensation Training, Memory Support System
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.
Computer Brain Fitness TrainingBehavioural
Also called Brain Fitness
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.
Support Group (patient and partner)Behavioural
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.
Wellness EducationBehavioural
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.
Physical ExerciseBehavioural
Also called Yoga
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.
| Study group | Role | What they receive |
|---|---|---|
| No Cognitive Rehabilitation | Experimental | Will receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise. Receives: Behavioral: Computer Brain Fitness Training; Behavioral: Support Group (patient and partner); Behavioral: Wellness Education; Behavioral: Physical Exercise |
| No Computer Brain Fitness Training | Experimental | Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise Receives: Behavioral: Cognitive Rehabilitation; Behavioral: Support Group (patient and partner); Behavioral: Wellness Education; Behavioral: Physical Exercise |
| No Support Group | Experimental | Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise Receives: Behavioral: Cognitive Rehabilitation; Behavioral: Computer Brain Fitness Training; Behavioral: Wellness Education; Behavioral: Physical Exercise |
| No Wellness Education | Experimental | Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise Receives: Behavioral: Cognitive Rehabilitation; Behavioral: Computer Brain Fitness Training; Behavioral: Support Group (patient and partner); Behavioral: Physical Exercise |
| No Physical Exercise | Experimental | Will receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education Receives: Behavioral: Cognitive Rehabilitation; Behavioral: Computer Brain Fitness Training; Behavioral: Support Group (patient and partner); Behavioral: Wellness Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in patient quality of life
quality of life measured by the QOL-AD scale
Measured: baseline to 18 months
Secondary outcomes (2)
improvement in patient memory based everyday functioning
measured by the Everyday Cognitive Functioning scale (ECOG)
Measured: 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)
Measured: baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startJun 2014
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Julie A. Fields, Ph.D., L.P., Mayo Clinic
- Investigators
- Julie Fields, PhD, LP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265757
- Sponsor's protocol ID
- 14-000885
- Status last verified
- Feb 2019
- First submitted
- 10 Oct 2014
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35415779Chandler 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.
PubMed 31099860Smith 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.
PubMed 29180344
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Behavioral Interventions to Prevent or Delay Dementia (CEBIPODD)
- ClinicalTrials.gov ID
- NCT02265757
- Acronym / sponsor ID
- 14-000885
- Conditions
- Mild Cognitive Impairment, Memory Disorders, Mild Dementia, Impaired Cognition, Mild Cognitive Disorder, Amnestic Disorder
- Keywords
- Behavioral Intervention, Mild Cognitive Impairment, HABIT, Cognitive Rehabilitation, Multi-Component Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jun 2014
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No Cognitive Rehabilitation | Experimental | Behavioral: Computer Brain Fitness Training, Behavioral: Support Group (patient and partner), Behavioral: Wellness Education, Behavioral: Physical ExerciseWill receive a 10 day intervention program (over 2 weeks) consisting of Computer Brain Fitness Training, Support Group, Wellness Education and Physical Exercise. |
| No Computer Brain Fitness Training | Experimental | Behavioral: Cognitive Rehabilitation, Behavioral: Support Group (patient and partner), Behavioral: Wellness Education, Behavioral: Physical ExerciseWill receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Support Group, Wellness Education and Physical Exercise |
| No Support Group | Experimental | Behavioral: Cognitive Rehabilitation, Behavioral: Computer Brain Fitness Training, Behavioral: Wellness Education, Behavioral: Physical ExerciseWill receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Wellness Education and Physical Exercise |
| No Wellness Education | Experimental | Behavioral: Cognitive Rehabilitation, Behavioral: Computer Brain Fitness Training, Behavioral: Support Group (patient and partner), Behavioral: Physical ExerciseWill receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Physical Exercise |
| No Physical Exercise | Experimental | Behavioral: Cognitive Rehabilitation, Behavioral: Computer Brain Fitness Training, Behavioral: Support Group (patient and partner), Behavioral: Wellness EducationWill receive a 10 day intervention program (over 2 weeks) consisting of Cognitive Rehabilitation, Computer Brain Fitness Training, Support Group, and Wellness Education |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RehabilitationAlso: Memory Compensation Training, Memory Support SystemWill 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. | Behavioural | No Computer Brain Fitness Training, No Physical Exercise, No Support Group, No Wellness Education |
| Computer Brain Fitness TrainingAlso: Brain FitnessWill 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. | Behavioural | No Cognitive Rehabilitation, No Physical Exercise, No Support Group, No Wellness Education |
| 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. | Behavioural | No Cognitive Rehabilitation, No Computer Brain Fitness Training, No Physical Exercise, No Wellness Education |
| Wellness EducationThe 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. | Behavioural | No Cognitive Rehabilitation, No Computer Brain Fitness Training, No Physical Exercise, No Support Group |
| Physical ExerciseAlso: YogaThe 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. | Behavioural | No Cognitive Rehabilitation, No Computer Brain Fitness Training, No Support Group, No Wellness Education |
Primary outcome
Improvement in patient quality of life
Time frame: baseline to 18 months
quality of life measured by the QOL-AD scale
2 secondary outcomes
improvement in patient memory based everyday functioning
Time frame: baseline to 18 months
improvement in caregiver mood and sense of burden
Time frame: baseline to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 35415779Levy 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.
- Derived from this study: PubMed 31099860Chandler 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.
- Derived from this study: PubMed 29180344Smith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Fields, PhD, LP principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation, Computer Brain Fitness Training and Support Group (patient and partner) in people with Mild Cognitive Impairment and Memory Disorders, run by Mayo Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in patient quality of life (time frame: baseline to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265757, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.