- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02702570
Committed Actions for Successful Aging (CASA)
March 16, 2020 updated by: Yonas E Geda, MD, Mayo Clinic
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
46 years to 86 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Participants will be recruited from the community via advertisement in retirement communities, church, and other social gatherings. Eligible participants are cognitively normal males and females aged 50 years and older.
Inclusion criteria:
- Subject will sign approved consent form
- Male or female adults (age > 50 years of age)
- Subject will complete all of the testing and procedures
Exclusion criteria:
- Refusal to sign the approved consent form
- Refusal to complete all testing and procedures of the study
- Males and females < age of 50 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: CASA intervention
Each participant serves as his/her own control.
Measures administered before and after an intervention.
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Each participant serves as his/her own control.
Measures administered before and after the behavioral intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline, one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale
Time Frame: Baseline, one year
|
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.
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Baseline, one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yonas E Geda, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
January 3, 2020
Study Completion (Actual)
January 3, 2020
Study Registration Dates
First Submitted
March 3, 2016
First Submitted That Met QC Criteria
March 7, 2016
First Posted (Estimate)
March 8, 2016
Study Record Updates
Last Update Posted (Actual)
March 18, 2020
Last Update Submitted That Met QC Criteria
March 16, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 14-008490
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.