Empower@Home:Connected - Feasibility and Preliminary Effect Study

Not Applicable

Completed

• Conditions: Loneliness; Social Isolation; Depression; Mood Disorders; Depressive Disorder; Mental Disorder

• Registration Number: NCT05732740
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Status Verified: 2023-09
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in De Jong Gierveld Scale	Change from baseline De Jong Gierveld Scale to post-test at 9 weeks	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.	Change from baseline PROMIS-Social Isolation to post-test at 9 weeks	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.
Change in Patient Health Questionnaire-9	Change from baseline PHQ9 to post-test at 9 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Generalized Anxiety Disorder Assessment-7	Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks	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 Patient-Reported Outcomes Measurment Information Systems- Global Health	Change from baseline PROMIS-Global Health to post-test at 9 weeks	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..
Changes in Health Related Quality of Life	Change from baseline Health-Related Quality of Life to post-test at 9 weeks	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States