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Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)

Community-Embedded, Layperson-Supported Digital Mental Health Intervention for Homebound Older Adults With Depression: A Type 1 Hybrid Effectiveness- Implementation RCT

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

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Qualitative interviews with participants will be conducted to provide deeper insights into these mechanisms and enhance the interpretation of the mediation analysis."
  • "Qualitative interviews will complement these findings by providing participant perspectives on how the program facilitated behavioral change."
  • "Data will be collected through interviews, meeting minutes, field observations, and other relevant sources, and analyzed using both traditional qualitative methods and natural language processing techniques."
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 talk therapy program that helps people change unhelpful thoughts and behaviors, with support from aging service providers. It is for adults age 50 or older who have signs of depression and are mostly unable to leave home. People are assigned by chance to the program or to usual care with added support.

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 aging service providers, in comparison to enhanced usual care for homebound older adults with depressive symptoms. A total of 256 participants will be randomly assigned to either the treatment group (Empower@Home) or the control group (enhanced usual care) in a 1:1 allocation ratio, with randomization stratified by participating agencies. The primary aim of this study is to determine the clinical effectiveness of the Empower@Home program. It is hypothesized that participants receiving Empower@Home will show greater improvements in depressive symptoms at 12, 24, and 36 weeks after entering the study compared to those receiving enhanced usual care. Additionally, treatment moderators will be explored and a cost-effectiveness analysis will be conducted to assess the economic viability of the intervention. The second aim is to investigate the mechanisms of change facilitated by the intervention using a mixed-methods approach. Causal mediation analysis will examine whether the acquisition of CBT skills, reduction in cognitive distortions, and increased behavioral activation, as well as participant engagement and the therapeutic alliance with the coach, mediate the treatment effects. Qualitative interviews with participants will be conducted to provide deeper insights into these mechanisms and enhance the interpretation of the mediation analysis. The third aim focuses on evaluating the implementation process using the updated Consolidated Framework for Implementation Research (CFIR). This will involve a qualitative process evaluation to identify barriers and facilitators to the implementation of Empower@Home, drawing on perspectives from multiple stakeholders.

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 enrolling people in the study.
  • Read and speak English.
  • Be age 50 or older.
  • Have at least moderate signs of depression, with a score of 8 or higher on the PHQ-9 depression survey.
  • If you are not in therapy outside the study, agree not to start during the study.
  • If you are already in therapy outside the study, agree not to have sessions more often during the study.

Who can't join

  • Likely have dementia, a condition that affects memory and thinking, based on a screening test.
  • Have a moderate or high risk of suicide based on a screening test.
  • Report an illness with 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.
  • Report severe vision loss, meaning you are legally blind.
  • Currently have a substance use disorder, meaning harmful 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 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 moderate depressive symptoms at screening (≥ 8 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. 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