Miles for Mental Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmporia State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Exercise
BehavioralAdults (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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Group Cardiovascular ExerciseExperimental treatment 1 intervention
Trial outcomes
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.
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.
Time frame
8 weeks2
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.
Time frame
8 weeksSecondary outcomes
1
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.
Time frame
8 weeks2
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.
Time frame
8 weeks3
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.
Time frame
8 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emporia State University
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: