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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    300
  • sponsor
    University of Michigan
Updated on 16 June 2022
depression
behavior therapy
behavioral therapy
depressive symptoms
depressed mood

Summary

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.

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.

Details
Condition Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders
Treatment Empower@Home
Clinical Study IdentifierNCT05384704
SponsorUniversity of Michigan
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥50 years
have at least mild depressive symptoms, based on PHQ-9 >=5
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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