Clinical trial NCT05593276: The Preliminary Effects of Empower@Home
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorder
Keywords: Cognitive Behavioral Therapy
Older Adults
Internet-Based Intervention
Depression
Social Isolation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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.

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 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.

Eligibility criteria: 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

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 Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health
timeFrame: Change from Baseline at 10 weeks
measure: Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation
timeFrame: Change from Baseline at 10 weeks
measure: Change in EQ5D-5L
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: