Empower@Home:Connected - Feasibility and Preliminary Effect Study

Depression Clinical Trial

Official title:

Evaluating the Feasibility and Preliminary Effect of Empower@Home: Connected for Depression, Social Isolation, and Loneliness Among Older Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05732740
• Other study ID #: HUM00212950-Group
• Status: Completed
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: September 22, 2023

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Loneliness
• Mental Disorder
• Mental Disorders
• Mood Disorders
• Social Isolation

Intervention

Behavioral:
• Empower@Home:Connected
Cognitive behavioral therapy

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline PHQ9 to post-test at 9 weeks
Primary	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.	Change from baseline De Jong Gierveld Scale to post-test at 9 weeks
Primary	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.	Change from baseline PROMIS-Social Isolation to post-test at 9 weeks
Secondary	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.	Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks
Secondary	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.	Change from baseline Health-Related Quality of Life to post-test at 9 weeks
Secondary	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..	Change from baseline PROMIS-Global Health to post-test at 9 weeks