The Preliminary Effects of Empower@Home

September 16, 2023 updated by: Xiaoling Xiang, University of Michigan

The Preliminary Effects of an Internet-delivered, Layperson Facilitated Cognitive Behavioral Therapy for Depression Among Chronically Ill Older Adults: A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist
Experimental: Internet-based program
Behavioral: Empower@Home
Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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.
Change from Baseline PHQ-9 at 10 weeks
Modified Treatment Evaluation Inventory
Time Frame: 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.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Time Frame: 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 from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health
Time Frame: 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 from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation
Time Frame: 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 from Baseline at 10 weeks
Change in EQ5D-5L
Time Frame: Change from Baseline at 10 weeks
Change in 5 item EQ5D-5L. Higher score indicates better health-related quality of life.
Change from Baseline at 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Xiaoling Xiang, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWD019703-HUM00212950

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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