Empower@Home:Connected - Feasibility and Preliminary Effect Study

University of Michigan

Status

Completed

Conditions

Mental Disorder

Loneliness

Depression

Mood Disorders

Depressive Disorder

Social Isolation

Treatments

Behavioral: Empower@Home:Connected

Study type

Interventional

Funder types

Other

Identifiers

NCT05732740

HUM00212950-Group

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

60+ years old

Volunteers

No 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