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Completed

NCT Number: NCT03143582

Examining the Effects of a Team-based Running Program

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.

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Key information

Conditions

Memory Attention Learning Mood Sleep Stress

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Youth Wellness Centre

Hamilton, Ontario, L8P 4W6, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy enough to participate in physical activity

Exclusion criteria

  • NOT excluded on basis of mental health or addiction concerns

Treatment and study plan

Running

Other

A 13-week running program where youth run for 30 minutes twice weekly.

Other names: Exercise

Primary outcomes

  1. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: 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.

    Nine-item self-report measure designed to monitor the severity of depressive symptoms using the diagnostic criteria found in the DSM-IV

  2. Generalized Anxiety Disorder 7 (GAD-7)

    Time frame: 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.

    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

  3. Kessler Psychological Distress Scale (K-10)

    Time frame: 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.

    Ten-item self-report measure of global psychological distress

Secondary outcomes

  1. PTSD Checklist for DSM-V (PCL-5)

    Time frame: 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.

    Twenty-item self-report measure of PTSD based on the DSM-V diagnostic criteria

  2. Rosenberg Self-Esteem Scale (RSES)

    Time frame: 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.

    Ten-item self-report measure of global feelings of self-worth

  3. Multidimensional Scale of Perceived Social Support

    Time frame: 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.

    Twelve-item self-report measure of perceived support from three sources: Family, friends, and a significant other

  4. Work and Social Adjustment Scale (WSAS)

    Time frame: 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.

    Five-item self-report measure of impairment in functioning

  5. Physical Activity and Sleep

    Time frame: Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.

    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

  6. Delis-Kramer Executive Function Tower Task

    Time frame: At baseline and 1-week after exercise program ends.

    Assesses spatial planning, rule learning, and response inhibition

  7. Hopkins Verbal Learning Task

    Time frame: At baseline and 1-week after exercise program ends.

    Tests participants' memory for a list of 12 nouns drawn from 3 categories, and measures immediate and delayed recall and recognition

  8. N-back

    Time frame: At baseline and 1-week after exercise program ends.

    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

  9. Concentration Memory Task

    Time frame: At baseline and 1-week after running program ends.

    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

  10. Town Square

    Time frame: At baseline and 1-week after running program ends.

    A test of viewpoint-dependent and -independent spatial memory for a set of visually presented items in a town square

  11. Wechsler Test of Adult Reading

    Time frame: At baseline

    A test to assess pre-morbid intellectual functioning by having the participants verbally speak a list of 50 irregular words

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 8, 2017
Registry last updated
Apr 21, 2020

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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