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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Empower@Home, an online therapy program with support from social service workers, against usual care with added support. The program teaches skills to change thoughts and actions that may worsen depression. It is for adults age 50 or older who have trouble walking or moving around and have symptoms of depression.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Receive services, or qualify for services, at a site recruiting people for the study.
  • Read and speak English.
  • Be age 50 or older.
  • Have at least mild depression symptoms, with a score of 5 or higher on the PHQ-9 depression screening test.
  • If not in therapy outside the study, agree not to start it during the study. If already in therapy, agree not to have sessions more often.
  • Report trouble moving around, such as walking or climbing stairs, on a set of 10 questions.

Who can't join

  • Likely have dementia, a condition that affects memory and thinking, based on a screening test.
  • Have a medium or high risk of suicide based on a screening test.
  • Report an illness expected to leave less than six months to live, or physical health problems that are not stable.
  • Have a diagnosis of a psychotic disorder, such as schizophrenia, or bipolar disorder, based on your report and medical records.
  • Report severe vision loss, meaning you are legally blind.
  • Currently have a substance use disorder, meaning problem use of alcohol or drugs, or receive treatment for it.
  • Have therapy outside the study more than once a month, or have started a new therapy treatment less than three months ago.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * (1) be receiving or eligible to receive services at the recruitment sites * (2) read and speak English * (3) be at least 50 years old * (4) have at least mild depressive symptoms at screening (≥ 5 on the Patient Health Questionnaire-9 \[PHQ-9\]). * (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) have mobility limitations based on self-reported limitations in 10 mobility related questions (e.g., difficulty climbing stairs or walking) Exclusion Criteria: * (1) probable dementia based on the Blessed Orientation and Memory Scale. * (2) moderate or high risk of suicide based on the 6-item Columbia-Suicide Severity Rating Scale * (3) a terminal illness with less than six months to live or unstable physical health conditions based on self-report * (4) a diagnosis of a psychotic disorder like schizophrenia or bipolar disorder based on self-report and medical chart review * (5) severe vision impairment based on self-report (i.e., legally blind) * (6) current substance use disorders or receiving substance use treatment. * (7) currently receiving outside therapy more frequently than once a month or have started a new therapy treatment less than 3 months ago

Study sites (1)

MI