University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT05593276
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.
Looking for future studies?
Notify Me60 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.
Time frame: Change from Baseline PHQ-9 at 10 weeks
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.
Time frame: 10 weeks
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.
Time frame: Change from Baseline at 10 weeks
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.
Time frame: Change from Baseline at 10 weeks
Change in 9 item standardized measure for global health. Total score ranges from 9 to 45, higher score means better global health.
Time frame: Change from Baseline at 10 weeks
Change in 8 item standardized measure for feelings of loneliness. Total score ranges from 8 to 40, higher score means higher levels of loneliness.
Time frame: Change from Baseline at 10 weeks
Change in 5 item EQ5D-5L. Higher score indicates better health-related quality of life.
University of Michigan
Other
The Preliminary Effects of an Internet-delivered, Layperson Facilitated Cognitive Behavioral Therapy for Depression Among Chronically Ill Older Adults: A Pilot Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05384704
Behavior, Behavioral Symptoms
Ann Arbor, Michigan, United States
View Trial DetailsNCT03460756
Behavior, Behavioral Symptoms
Glendale, California, United States
View Trial DetailsNCT05223842
Anhedonia, Behavior
Nashville, Tennessee, United States
View Trial DetailsNCT05732740
Behavior, Behavioral Symptoms
Ann Arbor, Michigan, United States
View Trial Details