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

NCT ID: NCT05384704

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-23
• Study Completion Date: 2024-03-30

Brief 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.

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 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based program

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

Group Type: EXPERIMENTAL

Empower@Home

Intervention Type: BEHAVIORAL

The intervention is a 9-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive weekly support from a trained research staff.

Interventions

Empower@Home

The intervention is a 9-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive weekly support from a trained research staff.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Xiaoling Xiang

Xiaoling Xiang, PhD, MSW, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoling Xiang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

HUM00212950

Identifier Type: -

Identifier Source: org_study_id