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Not yet recruiting Not applicable NCT07541443

Miles for Mental Health

No applicable phase (e.g. observational)
Conditions: Generalized Anxiety Disorder (GAD) Depressive and Anxiety Disorders

Sponsor: Emporia State University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Exercise
BEHAVIORAL
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
31.12.2026
Registry ID
NCT07541443
Source
clinicaltrials.gov
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