A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention

NCT05384704 | Completed

• 1 other identifier: HUM00212950
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single group study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 300 older adults throughout the state of Michigan to test the effectiveness of Empower@Home with older adults. The intervention will take approximately 10 weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.

Conditions

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders

Keywords

Cognitive Behavioral Therapy; Older Adults; Internet-Based Intervention; Depression; Social Isolation

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health Questionnaire-9 (PHQ-9)

  Change in 9 item standardized measures of depressive symptom severity. PHQ-9 score ranges from 0 to 27, with a higher score indicating more severe symptoms.

  Change from Baseline PHQ-9 at 10 weeks

• Modified Treatment Evaluation Inventory

  11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context. The score ranges from 11 to 55, and a higher score means higher acceptability.

  10 weeks

Secondary Outcomes (3)

• Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)

  Change from Baseline at 10 weeks

• Change in Duke Social Support Index (DSSI)-10

  Change from Baseline at 10 weeks

• Change in PROMISE-SI

  Change from Baseline at 10 weeks

Study Arms (1)

Internet-based program

EXPERIMENTAL

Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.

Behavioral: Empower@Home

Interventions

Empower@Home BEHAVIORAL

The intervention is a 9-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive weekly support from a trained research staff.

Internet-based program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥50 years
• have at least mild depressive symptoms, based on PHQ-9 \>=5
• 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 and with no in-home help to assist them with using a mobile device
• possible 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Behavior; Social Behavior

Study Officials

• Xiaoling Xiang, PhD

  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: Xiaoling Xiang, PhD, MSW, Assistant Professor

Model Details: The purpose of this research project is to assess the effectiveness of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. The program is intended to decrease depression in participants by encouraging them to participate in meaningful and enjoyable activities while challenging problematic thinking patterns.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: May 23, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)