Miles for Mental Health

Official title

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

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.

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.

Interventions

• 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 An

Primary outcome measures

• 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]
• 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]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07541443 · 26060 · P20GM103418

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗