Empower@Home:Connected - Feasibility and Preliminary Effect Study

NCT ID: NCT05732740

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2023-09-22

Brief Summary

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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

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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.

Conditions

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Depression Loneliness Social Isolation Depressive Disorder Mood Disorders Mental Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Participants will participant in 9 weekly group-based sessions

Group Type EXPERIMENTAL

Empower@Home:Connected

Intervention Type BEHAVIORAL

Cognitive behavioral therapy

Interventions

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Empower@Home:Connected

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Xiaoling Xiang

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jay Kayser, MSW

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00212950-Group

Identifier Type: -

Identifier Source: org_study_id

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