- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04689568
Improving Depression Via E-Health Access (IDEA) Study
Improving Depression Via E-Health Access (IDEA) Study: Evaluating Uptake and Efficacy of Self-Help e-Mental Health Interventions in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- The University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Moodkit
MoodKit is a cognitive behavioral therapy (CBT)-based app designed to provide tools for managing depressed mood, anxiety and stress.
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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.
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Active Comparator: Moodgym
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.
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The program consists of five modules each taking 20- to 40-minutes to complete, which are completed in a prescribed order.
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Active Comparator: University of Michigan Depression Center Toolkit
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.
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The Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey
Time Frame: Up to 14 months
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Up to 14 months
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Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey
Time Frame: Up to 14 months
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Structured survey conducted weekly.
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Up to 14 months
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Patient preference and satisfaction with the intervention as assessed by qualitative interviews
Time Frame: Up to approximately 14 months
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Interviews are semi-structured and audio recorded
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Up to approximately 14 months
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Care manager experiences of the intervention as assessed by qualitative interviews
Time Frame: Up to approximately 18 months
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Interviews are semi-structured and audio recorded
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Up to approximately 18 months
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Clinician/Administrator views related to interventions as assessed by qualitative interviews
Time Frame: Up to approximately 18 months
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Interviews are semi-structured and audio recorded
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Up to approximately 18 months
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Patient frequency of intervention use as assessed by self-report use of tools
Time Frame: Up to 14 months
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As recorded in participants' printed copy of their mood-logs from the app or program.
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Up to 14 months
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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)
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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.
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At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
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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)
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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)
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At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Severe, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00174081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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