An interventional study of Exercise -Running in Depression, Anxiety and Major Depressive Disorder, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
This study is being completed to see if participants activity levels may have an impact as a treatment for depression, or depressive symptoms.
Eligible participants will be enrolled and have an 8-week running intervention three times each week.
The study hypothesizes that adolescents with Psychiatric disorders that are experiencing depressive symptoms will participate in a supported running intervention.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 4 is below the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Exercise -Running
At baseline participants will wear a Fitbit for one week and attend the Runner's Assessment. After this the participant will begin to run 3 times per week for eight weeks. Every week, participation in a virtual support group with the physical therapist, research coordinator, and other research staff will be expected. Rest-activity cycles' data will be monitored; if at any point the runner is not able to complete 3 runs per week, participants will be encouraged to contact research staff the issues for this (such as medical problem or scheduling difficulty) and formulate plans to remediate the situation. Participants that would like to continue the treatment for an additional eight weeks will have additional data collected. Participants will also wear the Fitbit through-out the study and complete surveys during the study and have blood drawn.
The number of completed running sessions
Feasibility and acceptability of the study will be the completion of running sessions based on the Fitbit and or self-report.
Time frame: weeks 1-8 during treatment period
Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)
This is a self-report questionnaire designed for the purpose of assessing anxiety, mood, eating, and substance use disorders. For the first section (9 questions) the participants will select from Not at all (0) to nearly every day (3). The next section asks if in the past year participants felt depressed or sad most days (yes or no) and if so, not difficult at all to extremely difficult. The last question participants are asked about suicide. Scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression.
Time frame: Baseline (prior to treatment), 8 weeks (post intervention)
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in Apr 2024, 4 months.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 4 months is below that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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