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

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05384704

Collaborator

(none)

300

Enrollment

Location

Arm

28.3

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders	Behavioral: Empower@Home	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The purpose of this research project is to assess the effectiveness of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. The program is intended to decrease depression in participants by encouraging them to participate in meaningful and enjoyable activities while challenging problematic thinking patterns.The purpose of this research project is to assess the effectiveness of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. The program is intended to decrease depression in participants by encouraging them to participate in meaningful and enjoyable activities while challenging problematic thinking patterns.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluating the Effectiveness of Empower@Home for Depression Among Older Adults

Actual Study Start Date :

May 23, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

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. GAD7 score ranges from 0 to 21, higher score means more severe symptoms.
Change in Duke Social Support Index (DSSI)-10 [Change from Baseline at 10 weeks]
Change in 10 item standardized measure for social interaction and satisfaction with social support. Total score ranges from 10 to 30, higher score means higher social support.
Change in PROMISE-SI [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)