DepressionNCT05384704
A Single Group Study of Empower@Home-an Internet Cognitive Behavioral Therapy Intervention
A study testing Empower@Home in people with Depression and Depressive Disorder, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression, Depressive Disorder, Behavioral Symptoms
- What is being tested?
- Empower@Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2022to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥50 years
- have at least mild depressive symptoms, based on PHQ-9 >=5
- are willing to participate
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Empower@Home for Depression Among Older Adults
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.
Read the 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 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.
- Being tested
- Empower@Home
- Keywords
- Cognitive Behavioral Therapy, Older Adults, Internet-Based Intervention, Depression, Social Isolation
- Medical subject headings
- Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empower@HomeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based program | Experimental | Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues. Receives: Behavioral: Empower@Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: Change from Baseline PHQ-9 at 10 weeks
Modified Treatment Evaluation Inventory
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.
Measured: 10 weeks
Secondary outcomes (3)
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Change in 7-item standardized measure for severity of anxiety symptoms. GAD7 score ranges from 0 to 21, higher score means more severe symptoms.
Measured: Change from Baseline at 10 weeks
Change in Duke Social Support Index (DSSI)-10
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.
Measured: Change from Baseline at 10 weeks
Change in PROMISE-SI
Change in 8 item standardized measure for feelings of loneliness. Total score ranges from 8 to 40, higher score means higher levels of loneliness.
Measured: Change from Baseline at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start23 May 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Xiang, University of Michigan
- Investigators
- Xiaoling Xiang, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384704
- Sponsor's protocol ID
- HUM00212950
- Status last verified
- May 2024
- First submitted
- 17 May 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Empower@Home for Depression Among Older Adults
- ClinicalTrials.gov ID
- NCT05384704
- Acronym / sponsor ID
- HUM00212950
- Keywords
- Cognitive Behavioral Therapy, Older Adults, Internet-Based Intervention, Depression, Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Internet-based program | Experimental | Behavioral: Empower@HomeParticipants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥50 years
- have at least mild depressive symptoms, based on PHQ-9 >=5
- are willing to participate
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empower@HomeThe 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. | Behavioural | Internet-based program |
Primary outcome
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.
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.
3 secondary outcomes
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Time frame: Change from Baseline at 10 weeks
Change in Duke Social Support Index (DSSI)-10
Time frame: Change from Baseline at 10 weeks
Change in PROMISE-SI
Time frame: Change from Baseline at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoling Xiang, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empower@Home in people with Depression and Depressive Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: Change from Baseline PHQ-9 at 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.