An interventional study of Moodkit and Moodgym in Depression, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by University of Michigan · Not applicable, Interventional, and Health services research
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 32 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MoodKit is a cognitive behavioral therapy (CBT)-based app designed to provide tools for managing depressed mood, anxiety and stress.
Behavioral: Moodkit
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
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
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.
The program consists of five modules each taking 20- to 40-minutes to complete, which are completed in a prescribed order.
The Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey.
Patient preference, use and satisfaction of the intervention as assessed by timed structured survey
Time frame: Up to 14 months
Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey
Structured survey conducted weekly.
Time frame: Up to 14 months
Patient preference and satisfaction with the intervention as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
Time frame: Up to approximately 14 months
Care manager experiences of the intervention as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
Time frame: Up to approximately 18 months
Clinician/Administrator views related to interventions as assessed by qualitative interviews
Interviews are semi-structured and audio recorded
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Michigan