Clinical trial NCT06584422: Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)
Official title: Community-Embedded, Layperson-Supported Digital Mental Health Intervention for Homebound Older Adults With Depression: A Type 1 Hybrid Effectiveness- Implementation RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Cognitive behavioral therapy
Older Adults
Internet-based intervention
Depression
Social isolation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: NYU Silver School of Social Work
First posted: 2024-09-04
Enrollment: 256
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is a randomized Type I hybrid effectiveness-implementation trial designed to evaluate the clinical effectiveness and implementation process of Empower@Home, an internet-delivered cognitive-behavioral therapy (CBT) program tailored for homebound older adults with depressive symptoms. The trial compares Empower@Home, supported by aging service providers, to an enhanced usual care condition. The study involves 256 participants who will be randomly assigned to either the treatment or control group, with randomization stratified by agency.

Rationale: Depression is a significant public health concern among homebound older adults, with approximately 50% experiencing clinically significant depressive symptoms and 14% facing major depression-rates significantly higher than those of non-homebound counterparts. Homebound older adults often encounter barriers to accessing traditional mental health services, including physical disabilities, socioeconomic disadvantages, and racial or ethnic minority status. Empower@Home addresses these challenges by leveraging the existing workforce of aging service providers to support digital mental health interventions (DMHIs).

Intervention: Empower@Home is a nine-session, computerized CBT program enhanced with entertainment elements to increase engagement. The program is specifically designed for homebound older adults, incorporating age-relevant examples and a simplified user interface. It includes features such as a character-driven storyline, short videos, and interactive exercises to facilitate learning and engagement. The program is supported by lay coaches-aging service providers trained to offer weekly support calls, enhancing program adherence and personalization.

Study Aims:

Effectiveness: The primary aim is to determine the clinical effectiveness of Empower@Home compared to enhanced usual care. The hypothesis is that participants in the Empower@Home group will show greater improvements in depressive symptoms at 12, 24, and 36 weeks post-enrollment. Secondary clinical outcomes include improvements in anxiety, loneliness, social support, quality of life, disability burden, and pain severity.

Mechanisms of Change: The study will also explore the mechanisms through which the intervention produces change. Using a mixed-methods approach, the study will investigate whether CBT-related factors (e.g., skill acquisition, behavioral activation), engagement-related factors (e.g., narrative engagement), and coach-related factors (e.g., therapeutic alliance) mediate treatment effects. Qualitative interviews will complement these findings by providing participant perspectives on how the program facilitated behavioral change.

Implementation: The study will assess the implementation process using the updated Consolidated Framework for Implementation Research (CFIR). This qualitative process evaluation will identify barriers and facilitators to implementation from the perspectives of multiple stakeholders, including older adults, coaches, and agency staff. 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.

Study Design: Participants will be recruited from 3 to 4 aging service agencies that serve as implementation sites. These agencies represent diverse service delivery models, enhancing the study's external validity. Participants will undergo remote assessments via phone at baseline, post-intervention, and follow-up intervals at 12, 24, and 36 weeks. The study will also employ a cost-effectiveness analysis, evaluating the economic viability of the Empower@Home program from a public healthcare payer perspective.

Expected Outcomes: The study is expected to demonstrate that Empower@Home, when supported by aging service providers, is more effective and cost-effective than enhanced usual care in reducing depressive symptoms and improving other psychosocial outcomes. Additionally, the findings will provide valuable insights into the barriers and facilitators to implementing DMHIs in community settings, offering guidance for future scalability and sustainability of such interventions.

Innovation: Empower@Home integrates user-centered design principles, community participatory research, and innovative engagement strategies, such as character-driven storytelling, to enhance user experience and therapeutic outcomes. The use of aging service providers as lay coaches not only addresses the shortage of mental health professionals but also aligns with the existing infrastructure of aging services, making the program highly scalable and sustainable.

This trial will contribute significantly to the growing body of evidence on the effectiveness of DMHIs in real-world settings and inform strategies for broader implementation within community-based aging services.

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

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
Secondary outcomes:
measure: Change in Duke Social Support Index (DSSI)-10
timeFrame: Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
measure: Change in EuroQol 5-Dimension 5-level (EQ-5D-5L)
timeFrame: Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
measure: Change in Hamilton Depression Rating Scale (HAM-D)
timeFrame: Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
measure: Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Change from Baseline at 12, 24, and 36 weeks
measure: Change in Pain intensity assessed by the Pain, Enjoyment, and General Activity (PEG) Scale
timeFrame: Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
measure: Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
timeFrame: Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Xiaoling Xiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: