DepressionNCT04689568
Improving Depression Via E-Health Access (IDEA) Study
A study testing Moodkit, Moodgym and University of Michigan Depression Center Toolkit in people with Depression, run by University of Michigan at 1 site in United States.
Trial summary
The researchers are doing this study to learn more about which online self-help resources, including a smartphone app, an online program, or an informational website, primary care patients with depression are likely to choose and whether the chosen tool will improve their depressive symptoms and wellbeing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Moodkit, Moodgym and University of Michigan Depression Center Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2021to 1 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are English-speaking
- Individuals with a Patient Health Questionnaire 9 (PHQ9) score greater than or equal to 11 or diagnosis of moderate to severe depression determined by the Care Manager during her initial psychiatric evaluation and by the study PI during panel review will supersede a low PHQ9 score.
- Individuals with have daily internet access and a smartphone;
- Individuals who agree to periodic contact with the care manager and study team.
Who cannot join
- Individuals who have cognitive impairment that would preclude use of self-help resources
- Individuals with already using an electronic mental health resource;
- Individuals with unstable medical illness, e.g. active cancer;
- Individuals with severe psychiatric symptoms (marked suicidality, psychotic symptoms, severe substance abuse)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Improving Depression Via E-Health Access (IDEA) Study: Evaluating Uptake and Efficacy of Self-Help e-Mental Health Interventions in Primary Care
The researchers are doing this study to learn more about which online self-help resources, including a smartphone app, an online program, or an informational website, primary care patients with depression are likely to choose and whether the chosen tool will improve their depressive symptoms and wellbeing. The researchers would also like to know how likely someone is to use the resources and their satisfaction with the resources.
Read the detailed description
Participants will be using a self-help resource for the 6-week study period. A Care Manager will contact participants by phone, once a week, for about 5-10 minutes at a pre-arranged time. Participation will be needed for 10 weeks in total (6 weeks of active participation and a survey 1-month after the study intervention ends).
Subscription-based self-help resources being tested during the study will not be freely available after the study period. However, the researchers will share information on how to access these resources for a fee after the study period to all participants.
In addition to the time above, the researchers will collect information from participant's medical records for another 10 months after participation. The entire study is expected to last about 2 years.
- Conditions
- Depression
- Being tested
- Moodkit, Moodgym, University of Michigan Depression Center Toolkit
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoodkitBehavioural
MoodKit is divided into four main sections: Activities, Thoughts, Mood and Journal. In the Thoughts section, the user is asked to briefly describe stressful situations and their reactions to the event and is later educated on a number of "thought distortions". In the Mood section, the user is asked to give an overall rating of mood, which can be done several times per day. In the Journal section, the user can write freestanding journal entries. Additional areas of advice and goal setting are contained in a section called Thrive Tips.
MoodgymBehavioural
The program consists of five modules each taking 20- to 40-minutes to complete, which are completed in a prescribed order.
University of Michigan Depression Center ToolkitBehavioural
The Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey.
| Study group | Role | What they receive |
|---|---|---|
| Moodkit | Active comparator | MoodKit is a cognitive behavioral therapy (CBT)-based app designed to provide tools for managing depressed mood, anxiety and stress. Receives: Behavioral: Moodkit |
| Moodgym | Active comparator | Moodgym is an online cognitive behavioral therapy (CBT)-based program designed to prevent or reduce symptoms of depression and anxiety by helping users identify and overcome problem emotions and to develop good coping skills. Receives: Behavioral: Moodgym |
| University of Michigan Depression Center Toolkit | Active comparator | The Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey. The Toolkit offers help to people who are experiencing problems with a mood disorder as well as with stress and anxiety. Receives: Behavioral: University of Michigan Depression Center Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey
Measured: Up to 14 months
Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey
Structured survey conducted weekly.
Measured: Up to 14 months
Patient preference and satisfaction with the intervention as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
Measured: Up to approximately 14 months
Care manager experiences of the intervention as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
Measured: Up to approximately 18 months
Clinician/Administrator views related to interventions as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
Measured: Up to approximately 18 months
Patient frequency of intervention use as assessed by self-report use of tools
As recorded in participants' printed copy of their mood-logs from the app or program.
Measured: Up to 14 months
Change in severity of symptoms of depression as assessed with the Patient Health Questionnaire 9 (PHQ-9) score
The PHQ-9 is an instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 has a range of scores from 0-27. Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
Change in level of functioning as assessed with the Sheehan Disability Scale (SDS)
The Sheehan Disability Scale (SDS) is a 5-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on a continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)
Measured: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start27 Jan 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, non-randomized, preferred assignment study.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Severe, University of Michigan
- Investigators
- Jennifer Severe, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689568
- Sponsor's protocol ID
- HUM00174081
- Status last verified
- Mar 2023
- First submitted
- 27 Dec 2020
- Last updated
- 23 Mar 2023
- 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Depression Via E-Health Access (IDEA) Study: Evaluating Uptake and Efficacy of Self-Help e-Mental Health Interventions in Primary Care
- ClinicalTrials.gov ID
- NCT04689568
- Acronym / sponsor ID
- HUM00174081
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 30 Dec 2020 (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.
The researchers are doing this study to learn more about which online self-help resources, including a smartphone app, an online program, or an informational website, primary care patients with depression are likely to choose and whether the chosen tool will improve their depressive symptoms and wellbeing. The researchers would also like to know how likely someone is to use the resources and their satisfaction with the resources.
Detailed description
Participants will be using a self-help resource for the 6-week study period. A Care Manager will contact participants by phone, once a week, for about 5-10 minutes at a pre-arranged time. Participation will be needed for 10 weeks in total (6 weeks of active participation and a survey 1-month after the study intervention ends).
Subscription-based self-help resources being tested during the study will not be freely available after the study period. However, the researchers will share information on how to access these resources for a fee after the study period to all participants.
In addition to the time above, the researchers will collect information from participant's medical records for another 10 months after participation. The entire study is expected to last about 2 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a single-center, non-randomized, preferred assignment study.
| Arm | Type | Receives |
|---|---|---|
| Moodkit | Active comparator | Behavioral: MoodkitMoodKit is a cognitive behavioral therapy (CBT)-based app designed to provide tools for managing depressed mood, anxiety and stress. |
| Moodgym | Active comparator | Behavioral: MoodgymMoodgym is an online cognitive behavioral therapy (CBT)-based program designed to prevent or reduce symptoms of depression and anxiety by helping users identify and overcome problem emotions and to develop good coping skills. |
| University of Michigan Depression Center Toolkit | Active comparator | Behavioral: University of Michigan Depression Center ToolkitThe Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey. The Toolkit offers help to people who are experiencing problems with a mood disorder as well as with stress and anxiety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who are English-speaking
- Individuals with a Patient Health Questionnaire 9 (PHQ9) score greater than or equal to 11 or diagnosis of moderate to severe depression determined by the Care Manager during her initial psychiatric evaluation and by the study PI during panel review will supersede a low PHQ9 score.
- Individuals with have daily internet access and a smartphone;
- Individuals who agree to periodic contact with the care manager and study team.
Key exclusion criteria (4 listed)
- Individuals who have cognitive impairment that would preclude use of self-help resources
- Individuals with already using an electronic mental health resource;
- Individuals with unstable medical illness, e.g. active cancer;
- Individuals with severe psychiatric symptoms (marked suicidality, psychotic symptoms, severe substance abuse)
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 |
|---|---|---|
| MoodkitMoodKit is divided into four main sections: Activities, Thoughts, Mood and Journal. In the Thoughts section, the user is asked to briefly describe stressful situations and their reactions to the event and is later educated on a number of "thought distortions". In the Mood section, the user is asked to give an overall rating of mood, which can be done several times per day. In the Journal section, the user can write freestanding journal entries. Additional areas of advice and goal setting are contained in a section called Thrive Tips. | Behavioural | Moodkit |
| MoodgymThe program consists of five modules each taking 20- to 40-minutes to complete, which are completed in a prescribed order. | Behavioural | Moodgym |
| University of Michigan Depression Center ToolkitThe Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey. | Behavioural | University of Michigan Depression Center Toolkit |
Primary outcome
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey
Time frame: Up to 14 months
Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey
Time frame: Up to 14 months
Structured survey conducted weekly.
Patient preference and satisfaction with the intervention as assessed by qualitative interviews
Time frame: Up to approximately 14 months
Interviews are semi-structured and audio recorded
Care manager experiences of the intervention as assessed by qualitative interviews
Time frame: Up to approximately 18 months
Interviews are semi-structured and audio recorded
Clinician/Administrator views related to interventions as assessed by qualitative interviews
Time frame: Up to approximately 18 months
Interviews are semi-structured and audio recorded
Patient frequency of intervention use as assessed by self-report use of tools
Time frame: Up to 14 months
As recorded in participants' printed copy of their mood-logs from the app or program.
Change in severity of symptoms of depression as assessed with the Patient Health Questionnaire 9 (PHQ-9) score
Time frame: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
The PHQ-9 is an instrument for screening, diagnosing, monitoring and measuring the severity of depression: The PHQ-9 has a range of scores from 0-27. Depression Severity: 0- none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Change in level of functioning as assessed with the Sheehan Disability Scale (SDS)
Time frame: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
The Sheehan Disability Scale (SDS) is a 5-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on a continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)
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 23 Mar 2023.
- 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.
Jennifer Severe, MD 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 Moodkit, Moodgym and University of Michigan Depression Center Toolkit 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 4 inclusion and 4 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 23 Mar 2023. 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?
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey (time frame: Up to 14 months). The study lists 8 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 23 Mar 2023.