Exercise Training for Mental Illness

Overseen By Ryan Garten, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Cardiovascular medications

Disqualifiers: Smoking, Drug use, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of exercise training affect blood vessel health in individuals with mental health conditions like PTSD (post-traumatic stress disorder) and GAD (generalized anxiety disorder), as well as in healthy individuals. Participants will engage in one of three exercise routines: high-intensity, normal-volume; moderate-intensity, high-volume; or moderate-intensity, normal-volume. Those with PTSD, GAD, or who are generally healthy and not on medications affecting the heart might be suitable for this study. Individuals with symptoms of PTSD or GAD who are not taking heart-affecting medications are encouraged to join to explore the potential benefits of exercise. As an unphased trial, this study provides a unique opportunity to contribute to understanding the broader impacts of exercise on mental and cardiovascular health.

Will I have to stop taking my current medications?

If you are taking medications that could affect heart and blood vessel function, you may need to stop taking them to participate in this trial.

What prior data suggests that these exercise training methods are safe for individuals with mental health disorders?

Research has shown that exercise is generally safe and well-tolerated, even for individuals with mental health issues. For participants in the high-intensity, normal volume exercise program, studies have found that high-intensity interval training (HIIT) is a safe and feasible form of exercise, posing minimal risks for most people.

In the moderate-intensity, high-volume exercise program, physical activity is known to benefit mental health. It can reduce symptoms of depression and anxiety and enhance overall well-being, with no major safety concerns reported.

The moderate-intensity, normal volume exercise program is also safe and beneficial. Regular exercise is linked to better mood and improved mental health. Studies have shown that aerobic exercises can help with anxiety and sleep, without significant negative effects.

In summary, exercise programs, whether high or moderate intensity, are generally safe and can improve mental health without major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise training regimens for mental illness because they explore how varying intensity and volume might impact mental health outcomes. Unlike standard treatments, which often rely on medications like antidepressants or therapy, these exercise programs focus on physical activity as a therapeutic intervention. The different arms of the trial—high intensity with normal volume, moderate intensity with high volume, and moderate intensity with normal volume—allow researchers to pinpoint which combination might be most effective. This approach could offer a more accessible, holistic option that complements or even reduces the need for traditional interventions.

What evidence suggests that this trial's exercise training treatments could be effective for mental health disorders?

Research has shown that high-intensity interval training (HIIT), which participants in this trial may receive as part of the High Intensity, Normal Volume Exercise Training arm, can greatly improve anxiety symptoms. Studies have found that HIIT can lower anxiety and depression scores, making it a promising option for mental health. For those in the Moderate Intensity, High Volume Exercise Training arm, evidence suggests that this type of aerobic exercise can improve outcomes related to depression and anxiety, linking it to better mood and overall well-being. Participants in the Moderate Intensity, Normal Volume Exercise Training arm may also experience improvements, as this exercise can alleviate symptoms of depression and anxiety in many people. Overall, exercise boosts mood-related brain chemicals, enhancing stress management. ^{3 4 6 7 8}

Who Is on the Research Team?

Ryan Garten, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with PTSD or GAD who want to explore how different exercise routines affect blood vessel function. Participants should not have cardiovascular, pulmonary, or metabolic diseases. They must not be pregnant, on certain medications, recent smokers, drug users, heavy drinkers, or have significant dietary restrictions.

Inclusion Criteria

I am healthy with no major heart, lung, or metabolic diseases.

If you are in the PTSD group, you need to have a score of 33 or higher on the PCL-5 checklist.

For the GAD group, you have to score 10 or higher on the GAD-7 self-report scale and less than 33 on the PCL-5 checklist.

Exclusion Criteria

You use illegal drugs or drink too much alcohol.

You are not on a strict diet or have any vitamin or mineral deficiencies.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Testing

Participants undergo initial testing to familiarize with study equipment and procedures, determine body measures, maximum strength, and a blood draw

< 1 hour

1 visit (in-person)

Baseline Testing

Participants undergo baseline testing to determine blood vessel health, including antioxidant or placebo administration

2-3 hours per session

2 visits (in-person)

Exercise Training

Participants engage in 10 weeks of exercise training with varying intensity and volume

10 weeks

3-5 sessions per week

Post-Training Testing

Participants undergo post-training testing to assess changes in vascular function

2-3 hours per session

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity, Normal Volume Exercise Training
• Moderate Intensity, High Volume Exercise Training
• Moderate Intensity, Normal Volume Exercise Training

Trial Overview The study tests three types of exercise training: high intensity normal volume; moderate intensity normal volume; and moderate intensity high volume. It aims to see which routine best improves vascular function in both healthy people and those with mental health disorders.

How Is the Trial Designed?

Group I: Moderate Intensity, Normal Volume Exercise Training Experimental Treatment 1 Intervention

Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, normal volume exercise training

Group II: Moderate Intensity, High Volume Exercise Training Experimental Treatment 1 Intervention

Participants will complete study 1 (HM20020955-1) and then 10 weeks of moderate intensity, high volume exercise training

Group III: High Intensity, Normal Volume Exercise Training Experimental Treatment 1 Intervention

Participants will complete study 1 (HM20020955-1) and then 10 weeks of high intensity, normal volume exercise training

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

This feasibility study aims to assess the effectiveness of high-intensity interval training (HIIT) in improving physical and mental health among inpatients with severe mental illnesses (SMI), involving 40 patients in a randomized controlled trial over 12 weeks.

If HIIT is found to be feasible and acceptable, it could lead to larger studies evaluating its clinical and cost-effectiveness in inpatient mental health settings, potentially reversing cardiometabolic disease risks associated with SMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a pilot high-intensity interval training intervention in inpatient mental health settings: a two-part study using a randomised controlled trial and naturalistic study design. Martland, R., Onwumere, J., Stubbs, B., et al.[2021]

High intensity interval training (HIIT) has been shown to significantly reduce depression severity and improve various physical health metrics, such as cardiorespiratory fitness and HDL levels, in individuals with mental illnesses, based on a systematic review of 12 studies including 7 randomized controlled trials.

The review indicated that HIIT is safe, with no reported acute injuries, and participants showed good adherence to the training sessions, although dropout rates varied widely, highlighting the need for further research to improve retention in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high intensity interval training improve health outcomes among people with mental illness? A systematic review and preliminary meta-analysis of intervention studies across a range of mental illnesses. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

A systematic review of 6 studies found no overall difference in time trial (TT) performance improvements between high-intensity interval training (HIIT) and sprint interval training (SIT), indicating both methods are similarly effective for trained individuals.

However, long-duration HIIT (≥ 4 minutes) showed a 2% greater improvement in TT performance compared to SIT, suggesting that longer work intervals may be more beneficial for enhancing performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of High-Intensity Interval Training Versus Sprint Interval Training on Time-Trial Performance: A Systematic Review and Meta-analysis. Rosenblat, MA., Perrotta, AS., Thomas, SG.[2021]

High Intensity Interval Training (HIIT) is feasible and safe for individuals with severe mental illness (SMI), showing similar adherence rates to traditional moderate intensity continuous training (MCT).

HIIT resulted in moderate improvements in cardiorespiratory fitness and significantly greater reductions in depression compared to MCT, suggesting it may be a more effective exercise option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Intensity Interval training (HIIT) for people with severe mental illness: A systematic review & meta-analysis of intervention studies- considering diverse approaches for mental and physical recovery. Korman, N., Armour, M., Chapman, J., et al.[2022]

High-intensity aerobic training (HIT) significantly improved positive affect and well-being in patients with depression and schizophrenia, with patients maintaining these benefits longer than healthy individuals.

Both patient groups experienced reductions in distress and state anxiety shortly after HIT, with patients with depression showing a greater improvement in distress compared to healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High aerobic intensity training and psychological States in patients with depression or schizophrenia. Heggelund, J., Kleppe, KD., Morken, G., et al.[2023]

An 8-week high-intensity interval training (HIIT) program significantly improved physical health markers, including reductions in body weight, body mass index, and resting heart rate among 18 patients with chronic schizophrenia.

Mental health also showed improvement, with significant reductions in scores on the Positive and Negative Syndrome Scale, Beck Depression Inventory, and Beck Anxiety Inventory, indicating that HIIT can enhance both physical and mental well-being in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of high-intensity interval training on the mental and physical health of people with chronic schizophrenia. Wu, MH., Lee, CP., Hsu, SC., et al.[2020]

High-intensity interval training (HIIT) significantly reduced depressive symptoms in individuals with schizophrenia compared to low-intensity active video gaming, with a notable effect size that persisted even after a 4-month follow-up.

The reduction in depressive symptoms was associated with improvements in cardiorespiratory fitness (VO2max), suggesting that HIIT may have a beneficial impact on mental health through enhanced physical fitness, although the exact mechanisms require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training may reduce depressive symptoms in individuals with schizophrenia, putatively through improved VO2max: A randomized controlled trial. Bang-Kittilsen, G., Engh, JA., Holst, R., et al.[2022]

High-intensity interval training (HIIT) may help improve depressive symptoms in adults with mental disorders, as indicated by significant improvements in three out of four studies involving 108 participants over 12 days to 8 weeks.

However, HIIT did not show superior effectiveness compared to other forms of low-to-moderate continuous exercise in two-thirds of the studies, suggesting that while it can be beneficial, it may not be the best option for everyone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Rapid Review of Randomized Trials Assessing the Effects of High-Intensity Interval Training on Depressive Symptoms in People with Mental Illness. Ribeiro, JA., Schuch, FB., Vargas, KFM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11880788/

The impact of high-intensity interval training on anxiety Twelve studies indicated that HIIT significantly improves anxiety symptoms, especially for individuals with lower baseline anxiety.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178119317718

High Intensity Interval training (HIIT) for people with severe ... High intensity interval training (HIIT) was highly effective on a range of (mental) health parameters.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9148041/

Psychological Adaptations to High-Intensity Interval ... On the one hand, HIIT appears to lower anxiety and depression in populations suffering from physical and mental health issues [99]. On the other hand, ...

4. nature.com nature.com/articles/s41598-023-29503-1

Efficacy of high-intensity interval training for improving ... Mental health outcomes. The HIIT intervention reduced scores for depression (Δ − 1.7, P = 0.005), anxiety (Δ − 3.4, P < 0.001) and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/sms.14618

Effects of high‐intensity interval training on depressive and ... In general, it has been suggested that HIIT can be an effective strategy to improve aspects of mental health, such as well-being and severity of ...

6. bjsm.bmj.com bjsm.bmj.com/content/56/5/279.abstract

Can high-intensity interval training improve mental health ... High-intensity interval training (HIIT) is a safe and feasible form of exercise. The aim of this meta-analysis was to investigate the mental health effects of ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31883740/

High Intensity Interval training (HIIT) for people with severe ... There is a mortality gap of 15 to 20 years for people with severe mental illness (SMI - psychotic spectrum, bipolar, major depressive disorders).

8. nature.com nature.com/articles/s41598-024-79378-z

Effect of very low-carbohydrate high-fat diet and ... Our findings indicate that HIIT and VLCHF, alone or combined, do not significantly affect mental health-related indicators.