- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03294655
A Resilience Building Intervention to Promote Successful Aging (RISE)
April 1, 2019 updated by: Pariya L. Fazeli, PhD, University of Alabama at Birmingham
In this pilot study, a pre-post experimental design will be used, in which 60 community dwelling adults aged 50+ will recruited from a larger parent study, and will then be randomized to either a no-contact control or intervention condition.
Those in the intervention condition will receive a psychoeducational intervention in which they will receive scientific literature-based information on resilience and strategies to bolster resilience, as well as developing an individualized plan on areas to engage in at home over the next four weeks.
All participants will return for an immediate posttest using an abbreviated version of the baseline battery from the parent study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
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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Alabama
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Birmingham, Alabama, United States, 35294
- the Holly Mears Building/Center for Research on Applied Gerontology
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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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria/Exclusion Criteria:
- Must be enrolled in a larger parent study
- The criteria for the parent study are: no neurological or severe neuromedical disorders (e.g., stroke, schizophrenia), must be able to speak English, not be legally blind or deaf, not currently undergoing chemotherapy or radiation therapy, no brain trauma with loss of consciousness greater than 30 mins, and not homeless.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No contact control
the no contact control group will do nothing
|
|
Experimental: Intervention
the intervention condition will come to the lab for a 1 hour Pilot Resilience Building Intervention including a presentation on resilience and strategies to boost adherence, of which they will chose five to integrate in their daily life over the following 4 weeks
|
The intervention will include a brief one-on-one visit in which psychoeducational information on building resilience will be given via a PowerPoint presentation, which will include exercises for the participants to engage in over the following four weeks in their daily lives.
After the presentation participants will also develop a personalized intervention plan where they will choose at least five areas of the American Psychological Association 10 Strategies for Building Resilience on which to specifically focus.
Participants will also receive a pamphlet of abbreviated information from the PowerPoint presentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resilience
Time Frame: 4 weeks
|
Connor Davidson Resilience Scale
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
April 13, 2018
Primary Completion (Actual)
March 31, 2019
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
September 22, 2017
First Submitted That Met QC Criteria
September 22, 2017
First Posted (Actual)
September 27, 2017
Study Record Updates
Last Update Posted (Actual)
April 3, 2019
Last Update Submitted That Met QC Criteria
April 1, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Wheeler SON DSA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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