Generalized Anxiety Disorder (GAD)NCT07541443
Miles for Mental Health
A study testing Exercise in people with Generalized Anxiety Disorder (GAD) and Depressive and Anxiety Disorders, run by Emporia State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder (GAD), Depressive and Anxiety Disorders
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Miles for Mental Health: The Impact of Cardiovascular Exercise 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.
Read the 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.
- Being tested
- Exercise
- Keywords
- cardiovascular fitness, mental health, anxiety, depression, group exercise
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start10 Nov 2026 (estimated)
- Primary completion10 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emporia State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Erin Blocker, Emporia State University
- Investigators
- Steven E Blocker Jr, MS, LPC, Principal investigator, Emporia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541443
- Sponsor's protocol ID
- 26060
- Other IDs
- P20GM103418
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miles for Mental Health: The Impact of Cardiovascular Exercise on Mental Health Outcomes
- ClinicalTrials.gov ID
- NCT07541443
- Acronym / sponsor ID
- 26060
- Keywords
- cardiovascular fitness, mental health, anxiety, depression, group exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emporia State UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Cardiovascular Exercise | Experimental | Behavioral: ExerciseParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAdults (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. | Behavioural | Group Cardiovascular Exercise |
Primary outcome
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.
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.
3 secondary outcomes
Aim 2. Determine the impact of a structured group cardiovascular exercise and CBT program on cardiovascular fitness, reported as VO2max.
Time frame: 8 weeks
Aim 3a. Determine the relationship between cardiovascular fitness and anxiety symptoms, reported as scores on the PHQ-9 assessment.
Time frame: 8 weeks
Aim 3b. Determine the relationship between cardiovascular fitness and depressive symptoms, reported as scores on the GAD-7 assessment.
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven E Blocker Jr, MS, LPC principal investigator
Emporia State University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Generalized Anxiety Disorder (GAD) and Depressive and Anxiety Disorders, run by Emporia State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin M Blocker, PhD (16208036161, eblocker@emporia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.