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NCT Number: NCT05384704

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Mental Disorders Mood Disorders Social Behavior Social Isolation

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥50 years
  • have at least mild depressive symptoms, based on PHQ-9 >=5
  • 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)

Treatment and study plan

Empower@Home

Behavioral

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.

Primary outcomes

  1. Change in Patient Health Questionnaire-9 (PHQ-9)

    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.

  2. Modified Treatment Evaluation Inventory

    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.

Secondary outcomes

  1. Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)

    Time frame: Change from Baseline at 10 weeks

    Change in 7-item standardized measure for severity of anxiety symptoms. GAD7 score ranges from 0 to 21, higher score means more severe symptoms.

  2. Change in Duke Social Support Index (DSSI)-10

    Time frame: Change from Baseline at 10 weeks

    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.

  3. Change in PROMISE-SI

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 20, 2022
Registry last updated
Jun 4, 2024

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.

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