Empower@Home: A Feasibility Pilot

NCT05243264 | Completed

• 1 other identifier: 00207612
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open pilot feasibility study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 15 older adults throughout the state of Michigan to better understand the feasibility of the intervention and to probe preliminary effects. 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

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

  Change from Baseline PHQ-9 at 12 weeks

• Modified Treatment Evaluation Inventory

  11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context

  12 weeks

Secondary Outcomes (3)

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

  Change from Baseline at 12 weeks

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

  Change from Baseline at 12 weeks

• Change in PROMISE-SI

  Change from Baseline at 12 weeks

Study Arms (1)

Internet-Based Program

EXPERIMENTAL

Participants will be provided with access to a 10-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 10-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive a weekly check-in call to see how they are doing. The weekly check-in call is intended to be brief and last no more than 10 minutes on average.

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 \>=5
• are willing to participate

You may not qualify if:

• Currently receiving CBT or iCBT
• Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score \>= 10).
• They do not speak English
• have active suicidal ideation (any positive response on the 9th item of PHQ-9)
• Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
• Severe hearing or vision problems that prevent them from using a tablet/computer or viewing online content

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

Condition Hierarchy (Ancestors)

Behavioral Symptoms; 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: Assistant Professor

Model Details: The purpose of this research project is to assess the feasibility, acceptability, and preliminary effects 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: January 31, 2022
• First Posted: February 17, 2022
• Study Start: February 28, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)