DepressionNCT05593276
The Preliminary Effects of Empower@Home
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 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. Read more about this study
- Who is it for?
- Ages 60 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
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 30 Jan 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 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 >=8
- 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)
- Have a self reported psychotic disorder
- Currently receiving psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Preliminary Effects of an Internet-delivered, Layperson Facilitated Cognitive Behavioral Therapy for Depression Among Chronically Ill Older Adults: A Pilot Randomized Controlled Trial
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.
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 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.
- 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
Participants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist | No intervention | Not described |
| Internet-based program | Experimental | Not described 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 (4)
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
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.
Measured: Change from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health
Change in 9 item standardized measure for global health. Total score ranges from 9 to 45, higher score means better global health.
Measured: Change from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation
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
Change in EQ5D-5L
Change in 5 item EQ5D-5L. Higher score indicates better health-related quality of life.
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 posted25 Oct 2022
- Study start5 Jan 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- 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
- 70 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
- NCT05593276
- Sponsor's protocol ID
- AWD019703-HUM00212950
- Status last verified
- May 2024
- First submitted
- 20 Oct 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiang X, Kayser J, Turner S, Ash S, Himle JA. Layperson-Supported, Web-Delivered Cognitive Behavioral Therapy for Depression in Older Adults: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 4;26:e53001. doi: 10.2196/53001.
PubMed 38437013Kayser J, Wang X, Wu Z, Dimoji A, Xiang X. Layperson-Facilitated Internet-Delivered Cognitive Behavioral Therapy for Homebound Older Adults With Depression: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 22;12:e44210. doi: 10.2196/44210.
PubMed 36811937
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
- The Preliminary Effects of an Internet-delivered, Layperson Facilitated Cognitive Behavioral Therapy for Depression Among Chronically Ill Older Adults: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05593276
- Acronym / sponsor ID
- AWD019703-HUM00212950
- Keywords
- Cognitive Behavioral Therapy, Older Adults, Internet-Based Intervention, Depression, Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 25 Oct 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 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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 |
|---|---|---|
| Waitlist | No intervention | – |
| Internet-based program | Experimental | Behavioral: Empower@Home |
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 >=8
- are willing to participate
Key exclusion criteria (8 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@HomeParticipants will be provided with access to a 9-session online program and will receive supportive remote assistance throughout regarding technical and programmatic issues. | 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.
4 secondary outcomes
Change in Generalized Anxiety Disorder Assessment-7 (GAD-7)
Time frame: Change from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Global Health
Time frame: Change from Baseline at 10 weeks
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS)-Social Isolation
Time frame: Change from Baseline at 10 weeks
Change in EQ5D-5L
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.
- Derived from this study: PubMed 38437013Xiang X, Kayser J, Turner S, Ash S, Himle JA. Layperson-Supported, Web-Delivered Cognitive Behavioral Therapy for Depression in Older Adults: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 4;26:e53001. doi: 10.2196/53001.
- Derived from this study: PubMed 36811937Kayser J, Wang X, Wu Z, Dimoji A, Xiang X. Layperson-Facilitated Internet-Delivered Cognitive Behavioral Therapy for Homebound Older Adults With Depression: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 22;12:e44210. doi: 10.2196/44210.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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 8 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?
On the ClinicalTrials.gov record for NCT05593276, which also lists 2 linked publications.
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.