Improving Depression Via E-Health Access (IDEA) Study

NCT ID: NCT04689568

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2022-07-01

Brief Summary

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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

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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

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a single-center, non-randomized, preferred assignment study.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Moodkit

MoodKit is a cognitive behavioral therapy (CBT)-based app designed to provide tools for managing depressed mood, anxiety and stress.

Group Type ACTIVE_COMPARATOR

Moodkit

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Moodgym

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

University of Michigan Depression Center Toolkit

Intervention Type BEHAVIORAL

The Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey.

Interventions

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Moodkit

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

Moodgym

The program consists of five modules each taking 20- to 40-minutes to complete, which are completed in a prescribed order.

Intervention Type BEHAVIORAL

University of Michigan Depression Center Toolkit

The Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Severe

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Severe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00174081

Identifier Type: -

Identifier Source: org_study_id

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