Clinical trial NCT05384704: A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention
Official title: Evaluating the Effectiveness of Empower@Home for Depression Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Keywords: Cognitive Behavioral Therapy
Older Adults
Internet-Based Intervention
Depression
Social Isolation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from Baseline PHQ-9 at 10 weeks
measure: Modified Treatment Evaluation Inventory
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
timeFrame: Change from Baseline at 10 weeks
measure: Change in Duke Social Support Index (DSSI)-10
timeFrame: Change from Baseline at 10 weeks
measure: Change in PROMISE-SI
timeFrame: Change from Baseline at 10 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Xiaoling Xiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: