NCT02702570

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

March 3, 2016

Last Update Submit

March 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, one year

Secondary Outcomes (1)

  • Perceived Stress Scale

    Baseline, one year

Study Arms (1)

CASA intervention

OTHER

Each participant serves as his/her own control. Measures administered before and after an intervention.

Behavioral: CASA

Interventions

CASABEHAVIORAL

Each participant serves as his/her own control. Measures administered before and after the behavioral intervention.

CASA intervention

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject will sign approved consent form
  • Male or female adults (age \> 50 years of age)
  • Subject will complete all of the testing and procedures

You may not qualify if:

  • Refusal to sign the approved consent form
  • Refusal to complete all testing and procedures of the study
  • Males and females \< age of 50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

Study Officials

  • Yonas E Geda, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 8, 2016

Study Start

May 1, 2016

Primary Completion

January 3, 2020

Study Completion

January 3, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations