A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention
Primary Purpose
Depression, Depressive Disorder, Behavioral Symptoms
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empower@Home
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Cognitive Behavioral Therapy, Older Adults, Internet-Based Intervention, Depression, Social Isolation
Eligibility Criteria
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)
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Internet-based program
Arm Description
Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.
Outcomes
Primary Outcome Measures
Change in Patient Health Questionnaire-9 (PHQ-9)
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
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 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 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 in 8 item standardized measure for feelings of loneliness. Total score ranges from 8 to 40, higher score means higher levels of loneliness.
Full Information
NCT ID
NCT05384704
First Posted
May 17, 2022
Last Updated
September 16, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT05384704
Brief Title
A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention
Official Title
Evaluating the Effectiveness of Empower@Home for Depression Among Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders
Keywords
Cognitive Behavioral Therapy, Older Adults, Internet-Based Intervention, Depression, Social Isolation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based program
Arm Type
Experimental
Arm Description
Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.
Intervention Type
Behavioral
Intervention Name(s)
Empower@Home
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Change from Baseline PHQ-9 at 10 weeks
Title
Modified Treatment Evaluation Inventory
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Description
Change in 7-item standardized measure for severity of anxiety symptoms. GAD7 score ranges from 0 to 21, higher score means more severe symptoms.
Time Frame
Change from Baseline at 10 weeks
Title
Change in Duke Social Support Index (DSSI)-10
Description
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.
Time Frame
Change from Baseline at 10 weeks
Title
Change in PROMISE-SI
Description
Change in 8 item standardized measure for feelings of loneliness. Total score ranges from 8 to 40, higher score means higher levels of loneliness.
Time Frame
Change from Baseline at 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoling Xiang, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention
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