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NCT Number: NCT07541443

Miles for Mental Health

Common mental health disorders, like anxiety and depression, are widespread among the American population. The prevalence of mental health disorders among adults continues has consistently increased from previous decades and is now a major public health challenge. Data shows that 1 in 5 Americans regularly report feeling depressed. Therapy is supported as an effective means of treating mental anxiety and depression, and lessening their severity. But therapy is expensive and not always covered by insurance. It is well known that exercise provides physiological and psychological benefits to those suffering from mental health disorders. However, prescribing and monitoring exercise can be challenging, if not impossible, for mental health practitioners, and individuals often are unsure how to begin an exercise program on their own. Studies that have investigated the impact on exercise on mental health have delivered exercise using a traditional clinical trial exercise structure, where exercise is completed by the client/patient under the supervision of a professional. This structure, while beneficial, does not always transfer well to real-world settings. Working one-on-one with an exercise professional poses financial and scheduling barriers for most. Few, if any, studies have used group exercise and group therapy to address mental health concerns. This study aims to combine cardiovascular exercise with group therapy to investigate the impact of cardiovascular fitness on mental health outcomes among Rural dwelling adults living with generalized anxiety and/or depressive disorders.

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Key information

Conditions

Generalized Anxiety Disorder (GAD) Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive and Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The purpose of this project is to assess the impact of a weekly combined walking and jogging + cognitive behavior training (CBT) intervention on cardiovascular fitness and mental health outcomes among adults living with generalized anxiety and/or depressive disorders; and to determine the relationships, if any, between the study variables (cardiovascular fitness and anxiety/depression symptoms). Adults (ages 18 years +) living in Rural Kansas will be recruited to participate in a cardiovascular exercise group via referral from their mental health practitioner (clinical psychologist or clinical counselor). Prior to study initiation, anthropometric measurements, a one mile time trial (walking, jogging or running) and submaximal Cardiovascular Fitness (VO2submax) via a field test will be administered to all participants. In addition to the physical assessments, the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Screening Instrument (GAD-7) will be both be administered to participants.

Participants will then complete an 8-week walking/jogging + CBT exercise training program, led by the research team. The twice weekly sessions will focus on teaching individuals living with anxiety and depression how to incorporate regular cardiovascular exercise into their daily lives to benefit their mental health. Sessions will include 45-60 minutes of structured walking and/or jogging and Cognitive Behavioral Therapy (CBT) exercises led by a trained practitioner (clinical counselor and clinical psychology GA). The exercise training program will be designed collaboratively by the Co-PIs, who together have 35+ years of coaching and personal training experience and graduate degrees (MS and PhD respectively) in exercise physiology/sport science. CBT exercises may include journaling, personal reflection, goal setting and other validated exercises. Participants will be encouraged to progress from walking to jogging to running as they are able over the 8-week period.

All participants will receive a wearable fitness tracker to log their exercise time and distance, running shoes to use during the exercise sessions and a journal to use during CBT exercises.

Upon completion of the 8-week exercise intervention, all baseline assessments will be completed again. Statistical analyses will be conducted to assess all project aims.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18+ years
  • Generalized anxiety and/or depressive disorder diagnosis
  • Able to exercise without use of ambulatory device
  • Willing and able to attend a minimum of 2 group exercise sessions weekly

Exclusion criteria

  • Myocardial infarction or symptoms of coronary artery disease in the last 2yrs
  • Uncontrolled hypertension within the last 6 months
  • Cancer in the last 2yrs (except non-metastatic basal or squamous cell carcinoma)
  • Significant pain or musculoskeletal disorder that would prohibit participation in an exercise program
  • Possible/probably dementia or mild cognitive impairment (MCI) base on adjudication
  • Physician concern regarding safety or completion of the study

Treatment and study plan

Exercise

Behavioral

Adults (ages 18 years +) living in Rural Kansas will be recruited to participate in a cardiovascular exercise group via referral from their mental health practitioner (clinical psychologist or clinical counselor). Only participants with a diagnosis of generalized anxiety and/or a depressive disorder will be enrolled to participate in this study. Participants will complete a cardiovascular fitness assessment (VO2submax) via a field test, the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Screening Instrument (GAD-7). Participants will then be asked to complete twice weekly group walking and jogging sessions, coupled with short CBT activities. Sessions will include 45-60 minutes of structured walking and/or jogging and Cognitive Behavioral Therapy (CBT) exercises led by a trained practitioner (LPC and GRA in Clinical Psychology). Upon completion of the 8-week group exercise + CBT intervention, all assessments will be completed again and data analyzed.

Primary outcomes

  1. Aim 1a. Evaluate the impact of a structured group cardiovascular exercise and CBT program on anxiety symptoms as measured by scores on the PHQ-9 assessment.

    Time frame: 8 weeks

    Exercise is associated with positive mental health outcomes. The investigators hypothesize that participants in the combined cardiovascular and CBT program will see improvements on the PHQ-9 assessment.

  2. Aim 1b. Investigate the impacts of a structured group cardiovascular exercise and CBT program on depressive symptoms as measured by scores on the GAD-7 assessment.

    Time frame: 8 weeks

    Exercise is associated with positive mental health outcomes. The investigators hypothesize that participants in the combined cardiovascular and CBT program will see improvements on the GAD-7 assessment.

Secondary outcomes

  1. Aim 2. Determine the impact of a structured group cardiovascular exercise and CBT program on cardiovascular fitness, reported as VO2max.

    Time frame: 8 weeks

    Regular cardiovascular exercise is associated with improvements in cardiovascular fitness (VO2max and VO2 at submaximal intensities). The investigators hypothesize that this 8-week cardiovascular + CBT program will result in improvements in cardiovascular fitness.

  2. Aim 3a. Determine the relationship between cardiovascular fitness and anxiety symptoms, reported as scores on the PHQ-9 assessment.

    Time frame: 8 weeks

    Cardiovascular exercise has been linked to positive mental health outcomes. It is less clear whether there is a dose-response relationship between the two. The investigators hypothesize that individuals who see greater improvements in cardiovascular fitness will also see greater improvements in PHQ-9 assessment scores.

  3. Aim 3b. Determine the relationship between cardiovascular fitness and depressive symptoms, reported as scores on the GAD-7 assessment.

    Time frame: 8 weeks

    Cardiovascular exercise has been linked to positive mental health outcomes. It is less clear whether there is a dose-response relationship between the two. The investigators hypothesize that individuals who see greater improvements in cardiovascular fitness will also see greater improvements in GAD-7 assessment scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Erin M Blocker, PhD

CONTACT

[email protected]

16208036161

Mason Bina, BS - Graduate Research Asst.

CONTACT

[email protected]

316-303-6563

Sponsors and collaborators

Lead sponsor

Emporia State University

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Miles for Mental Health: The Impact of Cardiovascular Fitness on Mental Health Outcomes

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Jul 20, 2026

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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