Empower@Home:Connected - Feasibility and Preliminary Effect Study

NCT05732740 | Completed

• 1 other identifier: HUM00212950-Group
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Changes in Generalized Anxiety Disorder Assessment-7

  Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks

• Changes in Health Related Quality of Life

  Change from baseline Health-Related Quality of Life to post-test at 9 weeks

• Changes in Patient-Reported Outcomes Measurment Information Systems- Global Health

  Change from baseline PROMIS-Global Health to post-test at 9 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Participants will participant in 9 weekly group-based sessions

Behavioral: Empower@Home:Connected

Interventions

Empower@Home:Connected BEHAVIORAL

Cognitive behavioral therapy

Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=60 years
• have at least mild depressive symptoms, based on PHQ-9 \>=8
• are willing to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression; Social Isolation; Depressive Disorder; Mood Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Jay Kayser, MSW

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: January 17, 2023
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)