Miles for Mental Health

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Generalized Anxiety Disorder (GAD); Depressive and Anxiety Disorders
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin M Blocker, PhD; Phone Number: 16208036161; Email: eblocker@emporia.edu
• Study Contact Backup: Name: Mason Bina, BS - Graduate Research Asst.; Phone Number: 316-303-6563; Email: mbina@emporia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group Cardiovascular Exercise; Participants will 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 (LPC). Participants will be encouraged to attend a minimum of two (2) group cardiovascular exercise sessions weekly for the duration of the 8-week study.

Behavioral: Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	8 weeks
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.	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 2. Determine the impact of a structured group cardiovascular exercise and CBT program on cardiovascular fitness, reported as VO2max.	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.	8 weeks
Aim 3a. Determine the relationship between cardiovascular fitness and anxiety symptoms, reported as scores on the PHQ-9 assessment.	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.	8 weeks
Aim 3b. Determine the relationship between cardiovascular fitness and depressive symptoms, reported as scores on the GAD-7 assessment.	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.	8 weeks

Collaborators and Investigators

• Sponsor: Emporia State University
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Steven E Blocker Jr, MS, LPC, Emporia State University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: depression; mental health; anxiety; cardiovascular fitness; group exercise
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Anxiety Disorders; Depression; Psychological Well-Being; Generalized Anxiety Disorder; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 26060; P20GM103418 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The investigators do not plan to share individual participant data (IPD), including de-identified datasets, with researchers outside of the IRB-approved study team. Access to participant-level data will be restricted to authorized members of the research team as approved by the Institutional Review Board.

Only aggregate, summary-level results will be disseminated through peer-reviewed publications, conference presentations, and other scholarly or public dissemination outlets upon completion of the study. No individual-level data will be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No