Empower@Home: Hybrid Effectiveness-Implementation Randomized Controlled Trial (RCT)
NCT Number: NCT06584422
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: BEHAVIORAL: Empower@Home: An online cognitive-behavioral therapy self-care program for geriatric depression|OTHER: Telephone friendly visits
Sponsor: University of Michigan
Collaborators: National Institute of Mental Health (NIMH)|NYU Silver School of Social Work
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 256
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2029-07
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

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. We hypothesize 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, we will explore treatment moderators and perform a cost-effectiveness analysis 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. Through causal mediation analysis, we 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.

Primary Outcome Measures: Change in Patient Health Questionnaire-9 (PHQ-9), Change in 9 item standardized measures of depressive symptom severity. PHQ-9 score ranges from 0 to 27, with a higher score indicating more severe symptoms., Change from Baseline to follow-up assessments at 12, 24, and 36 weeks
Secondary Outcome Measures: Change in Duke Social Support Index (DSSI)-10, Change in 10 item standardized measure for social interaction and satisfaction with social support. Total score ranges from 10 to 30, higher score means higher social support., Change from Baseline to follow-up assessments at 12, 24, and 36 weeks|Change in EuroQol 5-Dimension 5-level (EQ-5D-5L), Change in 5 item standardized quality of life measure. EuroQol 5-Dimension 5-level is a commonly used tool to measure health-related quality of life. The final index score for the EQ-5D-5L is calculated by converting the health states described by a respondent into a single summary index value using a scoring algorithm. The EQ-5D-5L index score typically ranges from less than 0 (worse than death) to 1 (perfect health)., Change from Baseline to follow-up assessments at 12, 24, and 36 weeks|Change in Hamilton Depression Rating Scale (HAM-D), Change in 17-item clinician administered assessment of depression. HAM-D is an clinician-administered interview commonly used to assess depressive symptoms and will be administered by a Master of Social Work-prepared research staff who will complete the HAMD training offered by the Center for Telepsychology. Total scores range from 0 to 52, with a higher score indicating more severe symptoms., Change from Baseline to follow-up assessments at 12, 24, and 36 weeks|Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), Change in 12 item standardized measure for health and disability. The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) is a standardized tool developed by the World Health Organization for measuring health and disability across different cultures and settings. It captures the impact of a health condition on daily life across six domains: cognition, mobility, self-care, getting along with people, life activities, and participation in society. Total scores range from 0 to 60, higher scores means greater level of disability or loss of function., Change from Baseline at 12, 24, and 36 weeks|Change in Pain intensity assessed by the Pain, Enjoyment, and General Activity (PEG) Scale, Change in 3-item measure of chronic pain. The PEG Scale (Pain, Enjoyment, General Activity) is a brief, self-reported measure assessing three dimensions of chronic pain: pain intensity, the degree to which pain interferes with enjoyment of life, and the extent of its interference with general activity. Total scores range from 0 to 10, higher score means worse pain and more severe interference with life and activities., Change from Baseline to follow-up assessments at 12, 24, and 36 weeks|Change in Generalized Anxiety Disorder Assessment-7 (GAD-7), Change in 7-item standardized measure for severity of anxiety symptoms. GAD-7 score ranges from 0 to 21, higher score means more severe symptoms., Change from Baseline to follow-up assessments at 12, 24, and 36 weeks