Examining the Effects of a Team-based Running Program

Study Overview
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Brief Summary
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The investigators are interested in finding accessible interventions for youth and young adults that help promote long-term positive mental health functioning. They will be investigating the effects of Team Unbreakable, a 13-week, twice weekly running group, on mental health symptoms, memory, and attention. This intervention will hopefully improve mental health functioning in youth aged 17-25 that are at high risk of developing mental health disorders. Sessions will consist of 30 minutes of running under the supervision of group leaders and coaches. The group will steadily increase the distance and time spent running versus walking, with the goal of having everyone run a 5 km race together at the end of 13 weeks. Once a week, youth will be provided with education on a variety of topics related to health and running. Youth will complete measures before, during, and after the program to assess outcomes.

Official Title
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Examining the Effects of a Team-based Running Program on the Mental Health and Cognition of Emerging Adults: A Pilot Study

Conditions
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Memory, Learning, Mood, Attention, Stress, Sleep

Intervention / Treatment
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* Other: Running


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy enough to participate in physical activity Exclusion Criteria: NOT excluded on basis of mental health or addiction concerns

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open-label pilot study examining the effects of exercise on mood, learning, memory, attention, stress, and sleeping habits.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Running group<br>13 week, bi-weekly running group | Other: Running<br>* A 13-week running program where youth run for 30 minutes twice weekly.<br>* Other names: Exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 9 (PHQ-9) | Nine-item self-report measure designed to monitor the severity of depressive symptoms using the diagnostic criteria found in the DSM-IV | Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group. | 
| Generalized Anxiety Disorder 7 (GAD-7) | Seven-item self-report anxiety questionnaire designed to monitor and assess the severity of generalized anxiety disorder (GAD) symptoms, using the prominent diagnostic features found in the DSM-IV | Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group. | 
| Kessler Psychological Distress Scale (K-10) | Ten-item self-report measure of global psychological distress | Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist for DSM-V (PCL-5) | Twenty-item self-report measure of PTSD based on the DSM-V diagnostic criteria | Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group. | 
| Rosenberg Self-Esteem Scale (RSES) | Ten-item self-report measure of global feelings of self-worth | Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group. | 
| Multidimensional Scale of Perceived Social Support | Twelve-item self-report measure of perceived support from three sources: Family, friends, and a significant other | Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group. | 
| Work and Social Adjustment Scale (WSAS) | Five-item self-report measure of impairment in functioning | Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group. | 
| Physical Activity and Sleep | Participants will use a Fitbit to monitor their overall activity (e.g., steps, distance, active minutes, etc.) and sleep patterns before, during, and after treatment | Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group. | 
| Delis-Kramer Executive Function Tower Task | Assesses spatial planning, rule learning, and response inhibition | At baseline and 1-week after exercise program ends. | 
| Hopkins Verbal Learning Task | Tests participants' memory for a list of 12 nouns drawn from 3 categories, and measures immediate and delayed recall and recognition | At baseline and 1-week after exercise program ends. | 
| N-back | A test of executive function (working memory), requiring the participant to observe a sequence of items and click on targets that are repeats n items ago | At baseline and 1-week after exercise program ends. | 
| Concentration Memory Task | A test of high interference spatial memory. Participants search for pairs of matching cards and are periodically tested on which of two locations an item appeared in most recently | At baseline and 1-week after running program ends. | 
| Town Square | A test of viewpoint-dependent and -independent spatial memory for a set of visually presented items in a town square | At baseline and 1-week after running program ends. | 
| Wechsler Test of Adult Reading | A test to assess pre-morbid intellectual functioning by having the participants verbally speak a list of 50 irregular words | At baseline |