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Empower@Home: A Feasibility Pilot

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empower@Home
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

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

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ≥60 years
  2. have at least mild depressive symptoms, based on PHQ-9 >=5
  3. are willing to participate

Exclusion Criteria:

  1. Currently receiving CBT or iCBT
  2. Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >= 10).
  3. They do not speak English
  4. have active suicidal ideation (any positive response on the 9th item of PHQ-9)
  5. Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
  6. Severe hearing or vision problems that prevent them from using a tablet/computer or viewing online content

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 10-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
Modified Treatment Evaluation Inventory
11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context

Secondary Outcome Measures

Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Change in 7-item standardized measure for severity of anxiety symptoms
Change in Duke Social Support Index (DSSI)-10
Change in 10 item standardized measure for social interaction and satisfaction with social support
Change in PROMISE-SI
Change in 8 item standardized measure for feelings of loneliness

Full Information

First Posted
January 31, 2022
Last Updated
September 7, 2022
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05243264
Brief Title
Empower@Home: A Feasibility Pilot
Official Title
Empower@Home: A Feasibility Study of a Novel Internet-based Cognitive Behavioral Therapy Program for Depression Among Homebound Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open pilot feasibility study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 15 older adults throughout the state of Michigan to better understand the feasibility of the intervention and to probe preliminary effects. 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. The purpose of this research project is to assess the feasibility, acceptability, and preliminary effects of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. Our team developed Empower@Home collaboratively with older adult stakeholders and social service providers. It is the first iCBT program tailored for low-income racially diverse homebound seniors. It has the potential to reduce access barriers to mental health services among this high-need population. Although Empower@Home is based on an evidence-based mental health treatment (i.e., CBT), it is a novel intervention and has not yet been tested with human subjects. This is a pilot study that involves testing the feasibility, acceptability, and preliminary effects of the intervention with a single group of participants in an open trial. No randomization will occur. All eligible participants who consent will receive the intervention. A total of15 older adults will be recruited to participate in this study. All of them will be recruited through referrals from 2 to 3 social service agencies on this list (The Information Center, Region 2 Area Agency on Aging (AAA), Senior Resources, and A & D home care). The intervention involves attending up to 10 pre-recorded online therapy sessions and receiving weekly maintenance calls from trained research assistants for up to 12 weeks. Participants will engage in therapy at their private homes. A comprehensive baseline and post-test will be administered either over the phone or via an online survey, depending on the participants' preference. No in-person interaction between the participants and the research team is anticipated during the active treatment phase unless intervention is warranted for subjects' safety. Quantitative and qualitative data will be collected and analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
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 feasibility, acceptability, and preliminary effects 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
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-Based Program
Arm Type
Experimental
Arm Description
Participants will be provided with access to a 10-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 10-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive a weekly check-in call to see how they are doing. The weekly check-in call is intended to be brief and last no more than 10 minutes on average.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9)
Description
Change in 9 item standardized measures of depressive symptom severity
Time Frame
Change from Baseline PHQ-9 at 12 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
Time Frame
12 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
Time Frame
Change from Baseline at 12 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
Time Frame
Change from Baseline at 12 weeks
Title
Change in PROMISE-SI
Description
Change in 8 item standardized measure for feelings of loneliness
Time Frame
Change from Baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥60 years have at least mild depressive symptoms, based on PHQ-9 >=5 are willing to participate Exclusion Criteria: Currently receiving CBT or iCBT Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >= 10). They do not speak English have active suicidal ideation (any positive response on the 9th item of PHQ-9) Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months Severe hearing or vision problems that prevent them from using a tablet/computer or viewing online content
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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Empower@Home: A Feasibility Pilot

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