The Preliminary Effects of Empower@Home

Not Applicable

Completed

• Conditions: Mental Disorder; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders
• Interventions: Behavioral: Empower@Home

• Registration Number: NCT05593276
• Lead Sponsor: University of Michigan

Brief Summary

This randomized pilot trial uses a waitlist control parallel design of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 35 older adults per group throughout Michigan. The intervention will take approximately ten weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.

Detailed Description

Depression affects up to 40% of homebound seniors, but most homebound seniors do not receive psychotherapy due to various access barriers. The study team focuses on developing community-based solutions to reduce these access barriers. In a previously approved project HUM00207612, the study team tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. The pilot project allowed for refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a pilot randomized control trial to test the effectiveness of Empower@Home with older adults. Recruitment methods include 1) referrals from social service agencies, 2) advertisements on social media, local news outlets, and the program website, and 3) research participant registries.

The intervention involves attending up to 9 pre-recorded online therapy sessions and receiving weekly coaching calls from trained research assistants for up to 10 weeks. Participants will engage in therapy in their private homes. Three assessments are scheduled, including a comprehensive baseline, a post-test, and a 10-week follow-up. Each assessment takes about 20-40 minutes to complete over the phone.

Between Jan and Sept 2023, about 70 subjects (35 in each group) will be recruited. Participants will be randomized into the treatment group or waitlist control. The treatment group will receive the intervention immediately, whereas the waitlist control will wait for ten weeks before starting the intervention (i.e., after the 10-week "post-test"). Therefore, this is a cross-over design.

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-25
• Study Start: 2023-01-05
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• ≥60 years
• have at least mild depressive symptoms, based on PHQ-9 >=8
• are willing to participate

Exclusion Criteria

• Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >9).
• They do not speak English
• have active suicidal ideation, defined as moderate to high risk based on the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS)
• Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
• Have severe vision impairment that can not be corrected and with no in-home help to assist them with using a mobile device
• possible substance use disorders as assessed by the 4-item CAGE screener (>=2 on the CAGE AND have not been sober for at least one year)
• Have a self reported psychotic disorder
• Currently receiving psychotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based program	Empower@Home	-

Primary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire-9 (PHQ-9)	Change from Baseline PHQ-9 at 10 weeks	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.
Modified Treatment Evaluation Inventory	10 weeks	11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context. The score ranges from 11 to 55, and a higher score means higher acceptability.

Secondary Outcome Measures

Name	Time	Method
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)	Change from Baseline at 10 weeks	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 in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health	Change from Baseline at 10 weeks	Change in 9 item standardized measure for global health. Total score ranges from 9 to 45, higher score means better global health.
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation	Change from Baseline at 10 weeks	Change in 8 item standardized measure for feelings of loneliness. Total score ranges from 8 to 40, higher score means higher levels of loneliness.
Change in EQ5D-5L	Change from Baseline at 10 weeks	Change in 5 item EQ5D-5L. Higher score indicates better health-related quality of life.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States