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NCT Number: NCT04689568

Improving Depression Via E-Health Access (IDEA) Study

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

MoodGYM

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

Behavioral

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

Primary outcomes

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

    Time frame: Up to 14 months

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

    Time frame: Up to 14 months

    Structured survey conducted weekly.

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

    Time frame: Up to approximately 14 months

    Interviews are semi-structured and audio recorded

  4. Care manager experiences of the intervention as assessed by qualitative interviews

    Time frame: Up to approximately 18 months

    Interviews are semi-structured and audio recorded

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

    Time frame: Up to approximately 18 months

    Interviews are semi-structured and audio recorded

  6. Patient frequency of intervention use as assessed by self-report use of tools

    Time frame: Up to 14 months

    As recorded in participants' printed copy of their mood-logs from the app or program.

  7. 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)

    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.

  8. 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)

    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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Improving Depression Via E-Health Access (IDEA) Study: Evaluating Uptake and Efficacy of Self-Help e-Mental Health Interventions in Primary Care

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2020
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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