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Completed

NCT Number: NCT05732740

Empower@Home:Connected - Feasibility and Preliminary Effect Study

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.

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Key information

Conditions

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

Age range

60 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 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Empower@Home:Connected

Behavioral

Cognitive behavioral therapy

Primary outcomes

  1. Change in Patient Health Questionnaire-9

    Time frame: Change from baseline PHQ9 to post-test at 9 weeks

    Changes in 9-item standardized measure of depression symptom severity. PHQ-9 scores range from 0 to 27, with higher scores indicating more depressive symptoms.

  2. Changes in De Jong Gierveld Scale

    Time frame: Change from baseline De Jong Gierveld Scale to post-test at 9 weeks

    Change in 6-item De Jong Gierveld Short Scale for Emotional and Social Loneliness. Scores range from 0 to 6, with higher scores indicating more loneliness.

  3. Changes in Patient-Reported Outcomes Measurment Information Systems - Social Isolation.

    Time frame: Change from baseline PROMIS-Social Isolation to post-test at 9 weeks

    Changes in 8-item Patient-Reported Outcomes Measurment Information Systems - Social Isolation. PROMIS - SI scores range from 0 to 32, with higher scores indicating higher social isolation.

Secondary outcomes

  1. Changes in Generalized Anxiety Disorder Assessment-7

    Time frame: Change inGeneralized Anxiety Disorder Assessment-7 baseline to post-test at 9 weeks

    Changes in 7-item standardized measure for severity of anxiety symptoms. GAD-7 Scores range from 0 to 21, with higher values indicating higher anxiety.

  2. Changes in Health Related Quality of Life

    Time frame: Change from baseline Health-Related Quality of Life to post-test at 9 weeks

    Change in 5-item Health-Related Quality of Life. EQ5D-5L Scores range from 0 to 20 with higher scores indicating lower health related quality of life.

  3. Changes in Patient-Reported Outcomes Measurment Information Systems- Global Health

    Time frame: Change from baseline PROMIS-Global Health to post-test at 9 weeks

    Change in 9-item Patient-Reported Outcomes Measurment Information Systems - Global Health. PROMIS-GH scores range from 9 to 45, with higher scores meaning poorer global health..

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Evaluating the Feasibility and Preliminary Effect of Empower@Home: Connected for Depression, Social Isolation, and Loneliness Among Older Adults.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Oct 2, 2023

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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