The Preliminary Effects of Empower@Home

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05593276

Collaborator

(none)

Enrollment

Location

Arms

20.8

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized pilot trial uses a waitlist control cross-over 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.

Condition or Disease	Intervention/Treatment	Phase
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorder	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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover 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:

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

Anticipated Study Start Date :

Jan 5, 2023

Anticipated Primary Completion Date :

May 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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.

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.

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. GAD-7 score ranges from 0 to 21, higher score means more severe symptoms.
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health [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 in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation [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 in EQ5D-5L [Change from Baseline at 10 weeks]
Change in 5 item EQ5D-5L. Higher score indicates better health-related quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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