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Empower@Home:Connected - Feasibility and Preliminary Effect Study

Primary Purpose

Depression, Loneliness, Social Isolation

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

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 Have probable 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 or bipolar disorder

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Participants will participant in 9 weekly group-based sessions

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire-9
Changes in 9-item standardized measure of depression symptom severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more depressive symptoms.
Changes in De Jong Gierveld Scale
Change in 6-item De Jong Gierveld Short Scale for Emotional and Social Loneliness. Scores range from 0 to 6, with higher scores indicating more loneliness.
Changes in Patient-Reported Outcomes Measurment Information Systems - Social Isolation.
Changes in 8-item Patient-Reported Outcomes Measurment Information Systems - Social Isolation. PROMIS - SI scores range from 0 to 32, with higher scores indicating higher social isolation.

Secondary Outcome Measures

Changes in Generalized Anxiety Disorder Assessment-7
Changes in 7-item standardized measure for severity of anxiety symptoms. GAD-7 Scores range from 0 to 21, with higher values indicating higher anxiety.
Changes in Health Related Quality of Life
Change in 5-item Health-Related Quality of Life. EQ5D-5L Scores range from 0 to 20 with higher scores indicating lower health related quality of life.
Changes in Patient-Reported Outcomes Measurment Information Systems- Global Health
Change in 9-item Patient-Reported Outcomes Measurment Information Systems - Global Health. PROMIS-GH scores range from 9 to 45, with higher scores meaning poorer global health..

Full Information

First Posted
February 8, 2023
Last Updated
September 29, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05732740
Brief Title
Empower@Home:Connected - Feasibility and Preliminary Effect Study
Official Title
Evaluating the Feasibility and Preliminary Effect of Empower@Home: Connected for Depression, Social Isolation, and Loneliness Among Older Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
September 22, 2023 (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 single-group trial will evaluate the feasibility and preliminary effect of a novel group-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. Participants will complete the program remotely in small groups.
Detailed Description
Depression affects up to 40% of homebound seniors, but most do not receive psychotherapy due to various access barriers. This study focuses on developing community-based solutions to reduce access barriers. In a previously approved project HUM00207612, the investigators tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. This study will test an adapted version of Empower@Home called Empower@Home: Connected that is delivered in a group format and also addresses social isolation and loneliness. 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 9 group sessions. The sessions are facilitated by a mental health professional and involve psychoeducational material, cognitive-behavioral therapy exercises, and socialization. Sessions will occur on 9 consecutive weeks and will last approximately 90 minutes. Participants will complete a comprehensive baseline assessment and post-test. Each assessment will take between 40-60 minutes to complete over the phone. Recruitment will occur between January and April 2023, 20-25 participants will be recruited. All participants will receive the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Loneliness, Social Isolation, Depressive Disorder, Mood Disorders, Mental Disorder

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 preliminary effect of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home:Connected. The program is delivered in small groups remotely. It is intended to decrease depression, social isolation, and loneliness in participants by encouraging participants to take part in meaningful and enjoyable activities while challenging problematic thinking patterns.
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants will participant in 9 weekly group-based sessions
Intervention Type
Behavioral
Intervention Name(s)
Empower@Home:Connected
Intervention Description
Cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9
Description
Changes in 9-item standardized measure of depression symptom severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more depressive symptoms.
Time Frame
Change from baseline PHQ9 to post-test at 9 weeks
Title
Changes in De Jong Gierveld Scale
Description
Change in 6-item De Jong Gierveld Short Scale for Emotional and Social Loneliness. Scores range from 0 to 6, with higher scores indicating more loneliness.
Time Frame
Change from baseline De Jong Gierveld Scale to post-test at 9 weeks
Title
Changes in Patient-Reported Outcomes Measurment Information Systems - Social Isolation.
Description
Changes in 8-item Patient-Reported Outcomes Measurment Information Systems - Social Isolation. PROMIS - SI scores range from 0 to 32, with higher scores indicating higher social isolation.
Time Frame
Change from baseline PROMIS-Social Isolation to post-test at 9 weeks
Secondary Outcome Measure Information:
Title
Changes in Generalized Anxiety Disorder Assessment-7
Description
Changes in 7-item standardized measure for severity of anxiety symptoms. GAD-7 Scores range from 0 to 21, with higher values indicating higher anxiety.
Time Frame
Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks
Title
Changes in Health Related Quality of Life
Description
Change in 5-item Health-Related Quality of Life. EQ5D-5L Scores range from 0 to 20 with higher scores indicating lower health related quality of life.
Time Frame
Change from baseline Health-Related Quality of Life to post-test at 9 weeks
Title
Changes in Patient-Reported Outcomes Measurment Information Systems- Global Health
Description
Change in 9-item Patient-Reported Outcomes Measurment Information Systems - Global Health. PROMIS-GH scores range from 9 to 45, with higher scores meaning poorer global health..
Time Frame
Change from baseline PROMIS-Global Health to post-test at 9 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 >=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 Have probable 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 or bipolar disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Kayser, MSW
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:Connected - Feasibility and Preliminary Effect Study

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