RECRUITING

Empower@Home: Community Implementation for Older Adults with Ambulatory Disabilities

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Conditions

DepressionCognitive behavioral therapyOlder adultsInternet-based interventionSocial isolation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program supported by social service providers, in comparison to enhanced usual care for depression in older adults with ambulatory disabilities. A total of 64 participants with ambulatory disabilities will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio. This project addresses the following research questions: 1. Does the intervention affect individuals' lives in the following expected areas? 1. Does participation in the intervention lead to greater improvement in depressive symptoms than enhanced care as usual? 2. Does participation in the intervention lead to greater improvement in social engagement and activities than enhanced care as usual? 3. Is the intervention's primary effect mediated by CBT-related (e.g., CBT skills acquisition, cognitive distortions, and behavioral activation), engagement-related (e.g., character or storyline relatedness), and coach-related factors (e.g., therapeutic alliance)? 2. How is the intervention being adopted? What are the barriers and facilitators encountered during the implementation process?

Official Title

Empower@Home: Community Implementation for Older Adults with Ambulatory Disabilities

Quick Facts

Study Start:2024-12-10
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06721559

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.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * (1) be receiving home- and community-based services or case management at the recruitment sites
  2. * (2) read and speak English
  3. * (3) be at least 60 years old
  4. * (4) have at least moderate depressive symptoms at screening (≥ 8 on the Patient Health Questionnaire-9 \[PHQ-9\]).
  5. * (5) Participants who are NOT currently receiving outside therapy must agree NOT to start outside therapy during study participation. Participants who are currently receiving outside therapy must agree NOT to increase their outside therapy frequency during study participation.
  6. * (6) have mobility limitations based on self-reported limitations in 10 mobility related questions (e.g., difficulty climbing stairs or walking)
  1. * (1) probable dementia based on the Blessed Orientation and Memory Scale.
  2. * (2) moderate or high risk of suicide based on the 6-item Columbia-Suicide Severity Rating Scale
  3. * (3) a terminal illness with less than six months to live or unstable physical health conditions based on self-report
  4. * (4) a diagnosis of a psychotic disorder like schizophrenia or bipolar disorder based on self-report and medical chart review
  5. * (5) severe vision impairment based on self-report (i.e., legally blind)
  6. * (6) current substance use disorders or receiving substance use treatment.
  7. * (7) currently receiving outside therapy more frequently than once a month or have started a new therapy treatment less than 4 months ago

Contacts and Locations

Study Contact

Skyla Turner, MSW
CONTACT
734-215-5654
skturner@umich.edu
Xiaoling Xiang, PhD
CONTACT
734-215-5772
xiangxi@umich.edu

Principal Investigator

Xiaoling Xiang, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Xiaoling Xiang, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Registration Dates

Study Start Date2024-12-10
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-12-10
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Cognitive behavioral therapy
  • Older adults
  • Internet-based intervention
  • Depression
  • Social isolation

Additional Relevant MeSH Terms

  • Depression