Brain AgingCASANCT02702570
Committed Actions for Successful Aging
A study testing CASA in people with Brain Aging, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators are planning to recruit approximately 30 study participants aged 50 years and older that will undergo a 4 week attention and emotion regulation intervention. The intervention systematically targets thoughts, emotions and behavior in order to promote quality of life and advance successful brain aging. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Aging
- What is being tested?
- CASA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 3 Jan 2020
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject will sign approved consent form
- Male or female adults (age > 50 years of age)
- Subject will complete all of the testing and procedures
Who cannot join
- Refusal to sign the approved consent form
- Refusal to complete all testing and procedures of the study
- Males and females < age of 50 years
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are planning to recruit approximately 30 study participants aged 50 years and older that will undergo a 4 week attention and emotion regulation intervention. The intervention systematically targets thoughts, emotions and behavior in order to promote quality of life and advance successful brain aging. The investigators will assess the feasibility of recruiting and retaining participants for an attention and emotion regulation intervention. In addition, the investigators will determine the efficacy of the intervention to enhance and promote quality of life, sustained attention, emotions, motivation and cognitive health.
Read the detailed description
The CASA model is developed here in the investigators program (Geda et al) based on neuroscience and Acceptance and Commitment Therapy (ACT). The rationale for the study is that the cortico-cortical network linking the prefrontal cortex with the mesial temporal lobe is susceptible to the wear and tear of day to day life such as stress and emotional distress. The investigators hypothesize that the CASA intervention will promote emotional and cognitive health by targeting this network.
- Conditions
- Brain Aging
- Being tested
- CASA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASABehavioural
Each participant serves as his/her own control. Measures administered before and after the behavioral intervention.
| Study group | Role | What they receive |
|---|---|---|
| CASA intervention | Other | Each participant serves as his/her own control. Measures administered before and after an intervention. Receives: Behavioral: CASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHOQOL-BREF quality of life questionnaire
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. Scoring is 1-5 with 1 being either - Not at all, Very poor, Very dissatisfied, or Never. 2 being either - Not much, Poor, Dissatisfied, A little, or Seldom. 3 being either - Moderately, Neither poor nor good, Neither satisfied nor dissatisfied, A moderated amount, or Quite often. 4 being either - A great deal, Good, Satisfied, Very much, Mostly, Good, or Very often. 5 being either - Completely, Very good, Very satisfied, An extreme amount, Extremely, or Always.
Measured: Baseline, one year
Secondary outcomes (1)
Perceived Stress Scale
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale also includes a number of direct queries about current levels of experienced stress. The PSS was designed for use in community samples with at least a junior high school education. The questions are of a general nature and hence are relatively free of content specific to any subpopulation group. The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.
Measured: Baseline, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion3 Jan 2020
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AgingStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonas E Geda, MD, Mayo Clinic
- Investigators
- Yonas E Geda, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702570
- Sponsor's protocol ID
- 14-008490
- Acronym
- CASA
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2016
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Committed Actions for Successful Aging
- ClinicalTrials.gov ID
- NCT02702570
- Acronym / sponsor ID
- CASA / 14-008490
- Conditions
- Brain Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 8 Mar 2016 (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.
The investigators are planning to recruit approximately 30 study participants aged 50 years and older that will undergo a 4 week attention and emotion regulation intervention. The intervention systematically targets thoughts, emotions and behavior in order to promote quality of life and advance successful brain aging. The investigators will assess the feasibility of recruiting and retaining participants for an attention and emotion regulation intervention. In addition, the investigators will determine the efficacy of the intervention to enhance and promote quality of life, sustained attention, emotions, motivation and cognitive health.
Detailed description
The CASA model is developed here in the investigators program (Geda et al) based on neuroscience and Acceptance and Commitment Therapy (ACT). The rationale for the study is that the cortico-cortical network linking the prefrontal cortex with the mesial temporal lobe is susceptible to the wear and tear of day to day life such as stress and emotional distress. The investigators hypothesize that the CASA intervention will promote emotional and cognitive health by targeting this network.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CASA intervention | Other | Behavioral: CASAEach participant serves as his/her own control. Measures administered before and after an intervention. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject will sign approved consent form
- Male or female adults (age > 50 years of age)
- Subject will complete all of the testing and procedures
Key exclusion criteria (3 listed)
- Refusal to sign the approved consent form
- Refusal to complete all testing and procedures of the study
- Males and females < age of 50 years
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 |
|---|---|---|
| CASAEach participant serves as his/her own control. Measures administered before and after the behavioral intervention. | Behavioural | CASA intervention |
Primary outcome
WHOQOL-BREF quality of life questionnaire
Time frame: Baseline, one year
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. Scoring is 1-5 with 1 being either - Not at all, Very poor, Very dissatisfied, or Never. 2 being either - Not much, Poor, Dissatisfied, A little, or Seldom. 3 being either - Moderately, Neither poor nor good, Neither satisfied nor dissatisfied, A moderated amount, or Quite often. 4 being either - A great deal, Good, Satisfied, Very much, Mostly, Good, or Very often. 5 being either - Completely, Very good, Very satisfied, An extreme amount, Extremely, or Always.
1 secondary outcome
Perceived Stress Scale
Time frame: Baseline, one year
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 18 Mar 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Yonas E Geda, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASA in people with Brain Aging, run by Mayo Clinic at 1 site 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 3 inclusion and 3 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
WHOQOL-BREF quality of life questionnaire (time frame: Baseline, one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2020.