The Preliminary Effects of Empower@Home

Depression Clinical Trial

Official title:

The Preliminary Effects of an Internet-delivered, Layperson Facilitated Cognitive Behavioral Therapy for Depression Among Chronically Ill Older Adults: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05593276
• Other study ID #: AWD019703-HUM00212950
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Depression affects up to 40% of homebound seniors, but most homebound seniors do not receive psychotherapy due to various access barriers. The study team focuses on developing community-based solutions to reduce these access barriers. In a previously approved project HUM00207612, the study team tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. The pilot project allowed for refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a pilot randomized control trial to test the effectiveness of Empower@Home with older adults. 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 up to 9 pre-recorded online therapy sessions and receiving weekly coaching calls from trained research assistants for up to 10 weeks. Participants will engage in therapy in their private homes. Three assessments are scheduled, including a comprehensive baseline, a post-test, and a 10-week follow-up. Each assessment takes about 20-40 minutes to complete over the phone. Between Jan and Sept 2023, about 70 subjects (35 in each group) will be recruited. Participants will be randomized into the treatment group or waitlist control. The treatment group will receive the intervention immediately, whereas the waitlist control will wait for ten weeks before starting the intervention (i.e., after the 10-week "post-test"). Therefore, this is a cross-over design.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)	Change in 7-item standardized measure for severity of anxiety symptoms. GAD-7 score ranges from 0 to 21, higher score means more severe symptoms.	Change from Baseline at 10 weeks
Secondary	Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health	Change in 9 item standardized measure for global health. Total score ranges from 9 to 45, higher score means better global health.	Change from Baseline at 10 weeks
Secondary	Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation	Change in 8 item standardized measure for feelings of loneliness. Total score ranges from 8 to 40, higher score means higher levels of loneliness.	Change from Baseline at 10 weeks
Secondary	Change in EQ5D-5L	Change in 5 item EQ5D-5L. Higher score indicates better health-related quality of life.	Change from Baseline at 10 weeks