Improving Depression Via E-Health Access (IDEA) Study

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Moodgym; Behavioral: Moodkit; Behavioral: University of Michigan Depression Center Toolkit

• Registration Number: NCT04689568
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-27
• Study First Posted: 2020-12-30
• Study Start: 2021-01-27
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moodgym	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.
Moodkit	Moodkit	MoodKit is a cognitive behavioral therapy (CBT)-based app designed to provide tools for managing depressed mood, anxiety and stress.
University of Michigan Depression Center Toolkit	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.

Primary Outcome Measures

Name	Time	Method
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey	Up to 14 months
Care manager experiences of the intervention as assessed by qualitative interviews	Up to approximately 18 months	Interviews are semi-structured and audio recorded
Clinician/Administrator views related to interventions as assessed by qualitative interviews	Up to approximately 18 months	Interviews are semi-structured and audio recorded
Patient preference and satisfaction with the intervention as assessed by qualitative interviews	Up to approximately 14 months	Interviews are semi-structured and audio recorded
Change in level of functioning as assessed with the Sheehan Disability Scale (SDS)	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)
Change in severity of symptoms of depression as assessed with the Patient Health Questionnaire 9 (PHQ-9) score	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.
Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey	Up to 14 months	Structured survey conducted weekly.
Patient frequency of intervention use as assessed by self-report use of tools	Up to 14 months	As recorded in participants' printed copy of their mood-logs from the app or program.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States