Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584422
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
EmpowerHome Hybrid Effectiveness-Implementation Randomized Controlled Trial RCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Community-Embedded Layperson-Supported Digital Mental Health Intervention for Homebound Older Adults With Depression A Type 1 Hybrid Effectiveness- Implementation RCT
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized Type I hybrid effectiveness-implementation trial aimed at evaluating the effectiveness of EmpowerHome 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 EmpowerHome or the control group enhanced usual care in a 11 allocation ratio with randomization stratified by participating agencies
The primary aim of this study is to determine the clinical effectiveness of the EmpowerHome program It is hypothesized that participants receiving EmpowerHome 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 EmpowerHome drawing on perspectives from multiple stakeholders
The primary aim of this study is to determine the clinical effectiveness of the EmpowerHome program It is hypothesized that participants receiving EmpowerHome 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 EmpowerHome 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 EmpowerHome an internet-delivered cognitive-behavioral therapy CBT program tailored for homebound older adults with depressive symptoms The trial compares EmpowerHome 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 EmpowerHome addresses these challenges by leveraging the existing workforce of aging service providers to support digital mental health interventions DMHIs
Intervention EmpowerHome 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 EmpowerHome compared to enhanced usual care The hypothesis is that participants in the EmpowerHome 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 eg skill acquisition behavioral activation engagement-related factors eg narrative engagement and coach-related factors eg 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 study39s 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 EmpowerHome program from a public healthcare payer perspective
Expected Outcomes The study is expected to demonstrate that EmpowerHome 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 EmpowerHome 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
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 EmpowerHome addresses these challenges by leveraging the existing workforce of aging service providers to support digital mental health interventions DMHIs
Intervention EmpowerHome 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 EmpowerHome compared to enhanced usual care The hypothesis is that participants in the EmpowerHome 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 eg skill acquisition behavioral activation engagement-related factors eg narrative engagement and coach-related factors eg 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 study39s 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 EmpowerHome program from a public healthcare payer perspective
Expected Outcomes The study is expected to demonstrate that EmpowerHome 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 EmpowerHome 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None