Improving Depression Via E-Health Access (IDEA) Study

NCT04689568 | Completed

• 1 other identifier: HUM00174081
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (8)

• Patient preference, use and satisfaction of the intervention as assessed by timed structured survey

  Up to 14 months

• Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey

  Structured survey conducted weekly.

  Up to 14 months

• Patient preference and satisfaction with the intervention as assessed by qualitative interviews

  Interviews are semi-structured and audio recorded

  Up to approximately 14 months

• Care manager experiences of the intervention as assessed by qualitative interviews

  Interviews are semi-structured and audio recorded

  Up to approximately 18 months

• Clinician/Administrator views related to interventions as assessed by qualitative interviews

  Interviews are semi-structured and audio recorded

  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.

  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.

  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)

  At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)

Study Arms (3)

Moodkit

ACTIVE COMPARATOR

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

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.

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.

Behavioral: University of Michigan Depression Center Toolkit

Interventions

Moodkit 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.

Moodkit

Moodgym BEHAVIORAL

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

Moodgym

University of Michigan Depression Center Toolkit BEHAVIORAL

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

University of Michigan Depression Center Toolkit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jennifer Severe, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: This is a single-center, non-randomized, preferred assignment study.

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: January 27, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)