DepressionNCT05243264
Empower@Home: A Feasibility Pilot
A study testing Empower@Home in people with Depression, run by University of Michigan at 1 site in United States.
Trial summary
This is an open pilot feasibility study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 15 older adults throughout the state of Michigan to better understand the feasibility of the intervention and to probe… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 30 Aug 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥60 years
- have at least mild depressive symptoms, based on PHQ-9 >=5
- are willing to participate
Who cannot join
- Currently receiving CBT or iCBT
- Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >= 10).
- They do not speak English
- have active suicidal ideation (any positive response on the 9th item of PHQ-9)
- Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
- Severe hearing or vision problems that prevent them from using a tablet/computer or viewing online content
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empower@Home: A Feasibility Study of a Novel Internet-based Cognitive Behavioral Therapy Program for Depression Among Homebound Older Adults
This is an open pilot feasibility study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 15 older adults throughout the state of Michigan to better understand the feasibility of the intervention and to probe preliminary effects. 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. The purpose of this research project is to assess the feasibility, acceptability, and preliminary effects of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. Our team developed Empower@Home collaboratively with older adult stakeholders and social service providers. It is the first iCBT program tailored for low-income racially diverse homebound seniors. It has the potential to reduce access barriers to mental health services among this high-need population. Although Empower@Home is based on an evidence-based mental health treatment (i.e., CBT), it is a novel intervention and has not yet been tested with human subjects. This is a pilot study that involves testing the feasibility, acceptability, and preliminary effects of the intervention with a single group of participants in an open trial. No randomization will occur. All eligible participants who consent will receive the intervention. A total of15 older adults will be recruited to participate in this study. All of them will be recruited through referrals from 2 to 3 social service agencies on this list (The Information Center, Region 2 Area Agency on Aging (AAA), Senior Resources, and A \& D home care). The intervention involves attending up to 10 pre-recorded online therapy sessions and receiving weekly maintenance calls from trained research assistants for up to 12 weeks. Participants will engage in therapy at their private homes. A comprehensive baseline and post-test will be administered either over the phone or via an online survey, depending on the participants' preference. No in-person interaction between the participants and the research team is anticipated during the active treatment phase unless intervention is warranted for subjects' safety. Quantitative and qualitative data will be collected and analyzed.
- Conditions
- Depression
- Being tested
- Empower@Home
- Keywords
- Cognitive Behavioral Therapy, Older Adults, Internet-Based Intervention, Depression, Social Isolation
- Medical subject headings
- Depression, 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 10-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive a weekly check-in call to see how they are doing. The weekly check-in call is intended to be brief and last no more than 10 minutes on average.
| Study group | Role | What they receive |
|---|---|---|
| Internet-Based Program | Experimental | Participants will be provided with access to a 10-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
Measured: Change from Baseline PHQ-9 at 12 weeks
Modified Treatment Evaluation Inventory
11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context
Measured: 12 weeks
Secondary outcomes (3)
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Change in 7-item standardized measure for severity of anxiety symptoms
Measured: Change from Baseline at 12 weeks
Change in Duke Social Support Index (DSSI)-10
Change in 10 item standardized measure for social interaction and satisfaction with social support
Measured: Change from Baseline at 12 weeks
Change in PROMISE-SI
Change in 8 item standardized measure for feelings of loneliness
Measured: Change from Baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start28 Feb 2022
- Primary completion30 Jul 2022
- Study completion30 Aug 2022
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 feasibility, acceptability, and preliminary effects 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
- 10 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
- NCT05243264
- Sponsor's protocol ID
- 00207612
- Status last verified
- Sep 2022
- First submitted
- 31 Jan 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- 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 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empower@Home: A Feasibility Study of a Novel Internet-based Cognitive Behavioral Therapy Program for Depression Among Homebound Older Adults
- ClinicalTrials.gov ID
- NCT05243264
- Acronym / sponsor ID
- 00207612
- Conditions
- Depression
- Keywords
- Cognitive Behavioral Therapy, Older Adults, Internet-Based Intervention, Depression, Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 17 Feb 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 an open pilot feasibility study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 15 older adults throughout the state of Michigan to better understand the feasibility of the intervention and to probe preliminary effects. 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. The purpose of this research project is to assess the feasibility, acceptability, and preliminary effects of a novel internet-based cognitive behavioral therapy (iCBT) program called Empower@Home. Our team developed Empower@Home collaboratively with older adult stakeholders and social service providers. It is the first iCBT program tailored for low-income racially diverse homebound seniors. It has the potential to reduce access barriers to mental health services among this high-need population. Although Empower@Home is based on an evidence-based mental health treatment (i.e., CBT), it is a novel intervention and has not yet been tested with human subjects. This is a pilot study that involves testing the feasibility, acceptability, and preliminary effects of the intervention with a single group of participants in an open trial. No randomization will occur. All eligible participants who consent will receive the intervention. A total of15 older adults will be recruited to participate in this study. All of them will be recruited through referrals from 2 to 3 social service agencies on this list (The Information Center, Region 2 Area Agency on Aging (AAA), Senior Resources, and A \& D home care). The intervention involves attending up to 10 pre-recorded online therapy sessions and receiving weekly maintenance calls from trained research assistants for up to 12 weeks. Participants will engage in therapy at their private homes. A comprehensive baseline and post-test will be administered either over the phone or via an online survey, depending on the participants' preference. No in-person interaction between the participants and the research team is anticipated during the active treatment phase unless intervention is warranted for subjects' safety. Quantitative and qualitative data will be collected and analyzed.
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 feasibility, acceptability, and preliminary effects 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 10-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥60 years
- have at least mild depressive symptoms, based on PHQ-9 >=5
- are willing to participate
Key exclusion criteria (6 listed)
- Currently receiving CBT or iCBT
- Probable cognitive impairment based on the Blessed Orientation, Memory, and Concentration scale (score >= 10).
- They do not speak English
- have active suicidal ideation (any positive response on the 9th item of PHQ-9)
- Have a terminal illness or unstable physical health with a high risk of hospitalization within the next 3 months
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 10-week course of internet-based cognitive behavioral therapy. During the active intervention phase, participants will receive a weekly check-in call to see how they are doing. The weekly check-in call is intended to be brief and last no more than 10 minutes on average. | Behavioural | Internet-Based Program |
Primary outcome
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from Baseline PHQ-9 at 12 weeks
Change in 9 item standardized measures of depressive symptom severity
Modified Treatment Evaluation Inventory
Time frame: 12 weeks
11-item Likert scale relating to acceptability of program to participant modified for older adults and the study context
3 secondary outcomes
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Time frame: Change from Baseline at 12 weeks
Change in Duke Social Support Index (DSSI)-10
Time frame: Change from Baseline at 12 weeks
Change in PROMISE-SI
Time frame: Change from Baseline at 12 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 9 Sep 2022.
- 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, 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 9 Sep 2022. 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 12 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 9 Sep 2022.