A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention

University of Michigan

Status: Completed

Conditions: Mental Disorders; Behavioral Symptoms; Depression; Mood Disorders; Depressive Disorder

Treatments: Behavioral: Empower@Home

Study type: Interventional

Funder types: Other

Identifiers

NCT05384704

HUM00212950

Details and patient eligibility

About

This is a single group study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 300 older adults throughout the state of Michigan to test the effectiveness of Empower@Home with older adults. The intervention will take approximately 10 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.

Full 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 refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a larger single group study to test the effectiveness of Empower@Home with older adults. Recruitment methods include 1) referrals from social service agencies and 2) advertisements on social media and the program website.

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 40 minutes to complete over the phone or via an online survey, depending on the participants' preference.

Subjects will be recruited from agency referrals and advertisements. Between May 2022 and Dec 2023, about 300 subjects will be recruited into a single group study design where all eligible and consented participants will receive the intervention immediately without waiting.

Enrollment: 240 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥50 years
2. have at least mild depressive symptoms, based on PHQ-9 >=5
3. are willing to participate

Exclusion criteria

1. Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >9).
2. They do not speak English
3. have active suicidal ideation, defined as moderate to high risk based on the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS)
4. Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
5. Have severe vision impairment that can not be corrected and with no in-home help to assist them with using a mobile device
6. 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

Internet-based program

Experimental group

Description:

Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.

Treatment:

Behavioral: Empower@Home