<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294655</url>
  </required_header>
  <id_info>
    <org_study_id>Wheeler SON DSA</org_study_id>
    <nct_id>NCT03294655</nct_id>
  </id_info>
  <brief_title>A Resilience Building Intervention to Promote Successful Aging</brief_title>
  <acronym>RISE</acronym>
  <official_title>A Resilience Building Intervention to Promote Successful Aging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this pilot study, a pre-post experimental design will be used, in which 60 community&#xD;
      dwelling adults aged 50+ will recruited from a larger parent study, and will then be&#xD;
      randomized to either a no-contact control or intervention condition. Those in the&#xD;
      intervention condition will receive a psychoeducational intervention in which they will&#xD;
      receive scientific literature-based information on resilience and strategies to bolster&#xD;
      resilience, as well as developing an individualized plan on areas to engage in at home over&#xD;
      the next four weeks. All participants will return for an immediate posttest using an&#xD;
      abbreviated version of the baseline battery from the parent study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 13, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>pre-post experimental design, 60 adults aged 50+ will be randomized to either a no-contact control or intervention condition</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>only the post test assessor will be blinded to condition, as participants will know which condition they are assigned to</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Resilience</measure>
    <time_frame>4 weeks</time_frame>
    <description>Connor Davidson Resilience Scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Community Dwelling Adults Aged 50 and Older</condition>
  <arm_group>
    <arm_group_label>No contact control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the no contact control group will do nothing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pilot Resilience Building Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria/Exclusion Criteria:&#xD;
&#xD;
          -  Must be enrolled in a larger parent study&#xD;
&#xD;
          -  The criteria for the parent study are: no neurological or severe neuromedical&#xD;
             disorders (e.g., stroke, schizophrenia), must be able to speak English, not be legally&#xD;
             blind or deaf, not currently undergoing chemotherapy or radiation therapy, no brain&#xD;
             trauma with loss of consciousness greater than 30 mins, and not homeless.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>the Holly Mears Building/Center for Research on Applied Gerontology</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Pariya L. Fazeli, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294655
org study id: Wheeler SON DSA
nct id: NCT03294655
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: pre-post experimental design, 60 adults aged 50+ will be randomized to either a no-contact control or intervention condition
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: only the post test assessor will be blinded to condition, as participants will know which condition they are assigned to
measure: Resilience
time frame: 4 weeks
description: Connor Davidson Resilience Scale
arm group label: No contact control
arm group type: No Intervention
description: the no contact control group will do nothing
arm group label: Intervention
arm group type: Experimental
description: 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
intervention type: Behavioral
intervention name: Pilot Resilience Building Intervention
description: 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.
arm group label: Intervention
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Pariya L. Fazeli, PhD
investigator title: Assistant Professor
sharing ipd: No