Back to resultsImproving Depression Via E-Health Access (IDEA) Study
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moodkit
Moodgym
University of Michigan Depression Center Toolkit
Sponsored by
About this trial
This is an interventional health services research trial for Depression
Eligibility Criteria
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)
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Moodkit
Moodgym
University of Michigan Depression Center Toolkit
Arm Description
MoodKit is a cognitive behavioral therapy (CBT)-based app designed to provide tools for managing depressed mood, anxiety and stress.
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.
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.
Outcomes
Primary Outcome Measures
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey
Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey
Structured survey conducted weekly.
Patient preference and satisfaction with the intervention as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
Care manager experiences of the intervention as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
Clinician/Administrator views related to interventions as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
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.
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.
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04689568
First Posted
December 27, 2020
Last Updated
March 22, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT04689568
Brief Title
Improving Depression Via E-Health Access (IDEA) 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single-center, non-randomized, preferred assignment study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moodkit
Arm Type
Active Comparator
Arm Description
MoodKit is a cognitive behavioral therapy (CBT)-based app designed to provide tools for managing depressed mood, anxiety and stress.
Arm Title
Moodgym
Arm Type
Active Comparator
Arm Description
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.
Arm Title
University of Michigan Depression Center Toolkit
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moodkit
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moodgym
Intervention Description
The program consists of five modules each taking 20- to 40-minutes to complete, which are completed in a prescribed order.
Intervention Type
Behavioral
Intervention Name(s)
University of Michigan Depression Center Toolkit
Intervention Description
The Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey.
Primary Outcome Measure Information:
Title
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey
Time Frame
Up to 14 months
Title
Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey
Description
Structured survey conducted weekly.
Time Frame
Up to 14 months
Title
Patient preference and satisfaction with the intervention as assessed by qualitative interviews
Description
Interviews are semi-structured and audio recorded
Time Frame
Up to approximately 14 months
Title
Care manager experiences of the intervention as assessed by qualitative interviews
Description
Interviews are semi-structured and audio recorded
Time Frame
Up to approximately 18 months
Title
Clinician/Administrator views related to interventions as assessed by qualitative interviews
Description
Interviews are semi-structured and audio recorded
Time Frame
Up to approximately 18 months
Title
Patient frequency of intervention use as assessed by self-report use of tools
Description
As recorded in participants' printed copy of their mood-logs from the app or program.
Time Frame
Up to 14 months
Title
Change in severity of symptoms of depression as assessed with the Patient Health Questionnaire 9 (PHQ-9) score
Description
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.
Time Frame
At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
Title
Change in level of functioning as assessed with the Sheehan Disability Scale (SDS)
Description
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)
Time Frame
At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Severe, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Depression Via E-Health Access (IDEA) Study
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