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

Depression Clinical Trial

Official title:

Evaluating the Effectiveness of Empower@Home for Depression Among Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05384704
• Other study ID #: HUM00212950
• Status: Completed
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 refining study procedures and the web platform used to deliver the program. In this new project, the study team will conduct a larger single group study to test the effectiveness of Empower@Home with older adults. Recruitment methods include 1) referrals from social service agencies and 2) advertisements on social media and the program website.

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 40 minutes to complete over the phone or via an online survey, depending on the participants' preference.

Subjects will be recruited from agency referrals and advertisements. Between May 2022 and Dec 2023, about 300 subjects will be recruited into a single group study design where all eligible and consented participants will receive the intervention immediately without waiting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. =50 years

2. have at least mild depressive symptoms, based on PHQ-9 >=5

3. are willing to participate

Exclusion Criteria:

1. Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >9).

2. They do not speak English

3. have active suicidal ideation, defined as moderate to high risk based on the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS)

4. Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months

5. Have severe vision impairment that can not be corrected and with no in-home help to assist them with using a mobile device

6. 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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Empower@Home
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.

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. GAD7 score ranges from 0 to 21, higher score means more severe symptoms.	Change from Baseline at 10 weeks
Secondary	Change in Duke Social Support Index (DSSI)-10	Change in 10 item standardized measure for social interaction and satisfaction with social support. Total score ranges from 10 to 30, higher score means higher social support.	Change from Baseline at 10 weeks
Secondary	Change in PROMISE-SI	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