Aerobic Activity + CBT for Depression

MC
Overseen ByMadeleine Connolly, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if aerobic exercise immediately before cognitive behavioral therapy (CBT) enhances CBT's effectiveness for individuals with Major Depressive Disorder (MDD). Participants will either exercise or rest while watching a nature documentary before each of their 8 weekly CBT sessions. The trial seeks adults diagnosed with MDD who currently experience mild or higher depressive symptoms and have never undergone structured CBT. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations for MDD.

Do I have to stop taking my current medications for the trial?

If you are on a stable mental health medication regimen, you are encouraged to maintain it during the 8-week intervention period. If you are not currently taking any mental health medications, you can still participate.

What prior data suggests that this treatment method is safe?

Research has shown that aerobic exercise is generally safe and manageable for most people. Studies have found that activities like walking, jogging, and yoga can help reduce depression symptoms. Adding exercise to therapy could be beneficial without causing major side effects.

One study discovered that even minimal exercise can lower the risk of developing depression. This finding suggests that physical activity is not only safe but can also improve mental health over time.

Overall, aerobic exercise is a common and safe way to lift mood and reduce depression symptoms, making it a promising addition to therapy.12345

Why are researchers excited about this trial?

Researchers are excited about the Aerobic Activity + CBT approach for depression because it combines physical exercise with therapy in a novel way. Unlike traditional treatments that often rely solely on medication or therapy alone, this method integrates 30 minutes of aerobic activity before cognitive behavioral therapy (CBT), potentially enhancing the effectiveness of the therapy. The physical exercise may help boost mood and cognitive function even before the therapy session begins. Additionally, the CalmCBT arm provides a unique comparison by incorporating a restful period with a nature documentary before therapy, offering insights into how different preparatory activities might influence therapeutic outcomes.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that aerobic exercise can greatly reduce symptoms of depression. One study found that aerobic exercise had a moderate impact on lowering depression levels, with participants noticing improvements. Another review highlighted that both aerobic exercise and yoga helped reduce depressive symptoms by decreasing negative thoughts. Additionally, aerobic exercise is linked to better overall fitness, which can also boost mood. In this trial, one group of participants will complete 30 minutes of aerobic activity before cognitive behavioral therapy (CBT), potentially enhancing the therapy's effectiveness in treating depression.23678

Who Is on the Research Team?

JM

Jacob Meyer, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adults with Major Depressive Disorder who are safe to exercise, have a mild or greater level of depression, and haven't had structured CBT before. They should not be pregnant, nursing, or planning pregnancy; free from substance abuse disorders, psychosis, mania; without severe suicidal thoughts; and not severely obese.

Inclusion Criteria

Willing and safe to perform exercise based on responses on the Physical Activity Readiness Questionnaire
My depression diagnosis was confirmed by a clinical interview.
I am currently experiencing mild or more severe depression.
See 2 more

Exclusion Criteria

Reporting being currently pregnant, nursing, or planning to become pregnant during the study
Diagnosed with current Substance Use Disorder via the SCID
Diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder via the SCID
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either 30 minutes of aerobic exercise or rest before 8 weekly sessions of cognitive behavioral therapy (CBT)

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

52 weeks
3 visits (in-person) at weeks 9, 20, and 52

What Are the Treatments Tested in This Trial?

Interventions

  • Aerobic Activity
Trial Overview The study compares the effects of moderate aerobic exercise versus rest before cognitive behavioral therapy (CBT) sessions on treatment outcomes in depression. Participants will either engage in 'ActiveCBT' with prior exercise or 'CalmCBT' involving rest over 8 weeks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: CalmCBTExperimental Treatment1 Intervention
Group II: ActiveCBTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36796860/
Effectiveness of physical activity interventions for improving ...Physical activity had medium effects on depression (median effect size=-0.43, IQR=-0.66 to -0.27), anxiety (median effect size=-0.42, IQR=-0.66 ...
Effect of exercise for depression: systematic review and ...545556575859 One study found that both aerobic exercise and yoga led to decreased depression because participants ruminated less.
Influence of aerobic exercise on depression in young peopleThe results indicate that aerobic exercise has a significant positive impact on reducing depression levels in young individuals (d = -1.33, 95% ...
The impact of high-intensity exercise on patients with ...Among high-intensity exercise interventions, both aerobic and resistance training effectively alleviated depressive symptoms, whereas ...
The effects of aerobic exercise for depression: An umbrella ...The results indicate that aerobic exercise, as an intervention, significantly improves both cardiorespiratory fitness and depressive symptoms among patients ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38355154/
Effect of exercise for depression: systematic review and ...Exercise is an effective treatment for depression, with walking or jogging, yoga, and strength training more effective than other exercises, particularly when ...
Association Between Physical Activity and Risk of ...In this study, relatively small doses of physical activity were associated with substantially lower risks of depression.
Physical Activity and Incident Depression: A Meta-Analysis ...Our meta-analysis suggests that physical activity is associated with a decrease in the risk of developing depression, which raises an inevitable ...
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