The Preliminary Effects of Empower@Home

NCT05593276 | Completed

• 1 other identifier: AWD019703-HUM00212950
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot trial uses a waitlist control parallel design of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 35 older adults per group throughout Michigan. The intervention will take approximately ten 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 Disorder

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 (4)

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

  Change from Baseline at 10 weeks

• Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health

  Change from Baseline at 10 weeks

• Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation

  Change from Baseline at 10 weeks

• Change in EQ5D-5L

  Change from Baseline at 10 weeks

Study Arms (2)

Waitlist

NO INTERVENTION

Internet-based program

EXPERIMENTAL

Behavioral: Empower@Home

Interventions

Empower@Home BEHAVIORAL

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

Internet-based program

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 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)
• Have a self reported psychotic disorder
• Currently receiving psychotherapy

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Xiang X, Kayser J, Turner S, Ash S, Himle JA. Layperson-Supported, Web-Delivered Cognitive Behavioral Therapy for Depression in Older Adults: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 4;26:e53001. doi: 10.2196/53001.

  PMID: 38437013 DERIVED

• Kayser J, Wang X, Wu Z, Dimoji A, Xiang X. Layperson-Facilitated Internet-Delivered Cognitive Behavioral Therapy for Homebound Older Adults With Depression: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 22;12:e44210. doi: 10.2196/44210.

  PMID: 36811937 DERIVED

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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: October 20, 2022
• First Posted: October 25, 2022
• Study Start: January 5, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)