Improving Depression Via E-Health Access (IDEA) Study

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689568
• Other study ID #: HUM00174081
• Status: Completed
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.
• Moodgym
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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient preference, use and satisfaction of the intervention as assessed by timed structured survey		Up to 14 months
Primary	Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey	Structured survey conducted weekly.	Up to 14 months
Primary	Patient preference and satisfaction with the intervention as assessed by qualitative interviews	Interviews are semi-structured and audio recorded	Up to approximately 14 months
Primary	Care manager experiences of the intervention as assessed by qualitative interviews	Interviews are semi-structured and audio recorded	Up to approximately 18 months
Primary	Clinician/Administrator views related to interventions as assessed by qualitative interviews	Interviews are semi-structured and audio recorded	Up to approximately 18 months
Primary	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
Primary	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)
Primary	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)