Clinical trial NCT05732740: Empower@Home:Connected - Feasibility and Preliminary Effect Study
Official title: Evaluating the Feasibility and Preliminary Effect of Empower@Home: Connected for Depression, Social Isolation, and Loneliness Among Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Loneliness
Social Isolation
Depressive Disorder
Mood Disorders
Mental Disorder
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 37
Sex: ALL
Minimum age (years): 60
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 preliminary effect of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home:Connected. The program is delivered in small groups remotely. It is intended to decrease depression, social isolation, and loneliness in participants by encouraging participants to take part in meaningful and enjoyable activities while challenging problematic thinking patterns.
Primary purpose: TREATMENT

Brief summary: This single-group trial will evaluate the feasibility and preliminary effect of a novel group-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. Participants will complete the program remotely in small groups.

Detailed description: Depression affects up to 40% of homebound seniors, but most do not receive psychotherapy due to various access barriers. This study focuses on developing community-based solutions to reduce access barriers. In a previously approved project HUM00207612, the investigators tested the feasibility of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. This study will test an adapted version of Empower@Home called Empower@Home: Connected that is delivered in a group format and also addresses social isolation and loneliness. 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 9 group sessions. The sessions are facilitated by a mental health professional and involve psychoeducational material, cognitive-behavioral therapy exercises, and socialization. Sessions will occur on 9 consecutive weeks and will last approximately 90 minutes. Participants will complete a comprehensive baseline assessment and post-test. Each assessment will take between 40-60 minutes to complete over the phone. Recruitment will occur between January and April 2023, 20-25 participants will be recruited. All participants will receive the intervention.

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
* Have probable 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 or bipolar disorder

Primary outcomes:
measure: Change in Patient Health Questionnaire-9
timeFrame: Change from baseline PHQ9 to post-test at 9 weeks
measure: Changes in De Jong Gierveld Scale
timeFrame: Change from baseline De Jong Gierveld Scale to post-test at 9 weeks
measure: Changes in Patient-Reported Outcomes Measurment Information Systems - Social Isolation.
timeFrame: Change from baseline PROMIS-Social Isolation to post-test at 9 weeks
Secondary outcomes:
measure: Changes in Generalized Anxiety Disorder Assessment-7
timeFrame: Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks
measure: Changes in Health Related Quality of Life
timeFrame: Change from baseline Health-Related Quality of Life to post-test at 9 weeks
measure: Changes in Patient-Reported Outcomes Measurment Information Systems- Global Health
timeFrame: Change from baseline PROMIS-Global Health to post-test at 9 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jay Kayser, MSW
role: PRINCIPAL_INVESTIGATOR
References: