Miles for Mental Health

NCT07541443 | Not Yet Recruiting

• 2 other identifiers: 26060P20GM103418
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Generalized Anxiety Disorder (GAD); Depressive and Anxiety Disorders

Keywords

cardiovascular fitness; mental health; anxiety; depression; group exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  8 weeks

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

  8 weeks

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

  8 weeks

Study Arms (1)

Group Cardiovascular Exercise

EXPERIMENTAL

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

Interventions

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.

Group Cardiovascular Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emporia State University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders; Psychological Well-Being; Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Steven E Blocker Jr, MS, LPC

  Emporia State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin M Blocker, PhD

CONTACT

16208036161; eblocker@emporia.edu

Mason Bina, BS - Graduate Research Asst.

CONTACT

316-303-6563; mbina@emporia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share