Enhanced Cognitive Behavioral Therapy for Depression

(CBT+ Trial)

Overseen By Jacob Meyer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Iowa State University

Disqualifiers: Pregnancy, Severe obesity, Psychosis, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether adding exercise before therapy sessions can enhance the effects of cognitive behavioral therapy (CBT) for treating depression. Participants will either watch a nature documentary while resting or exercise on a stationary bike before their therapy sessions. This study targets adults diagnosed with Major Depressive Disorder who have never tried CBT and are either not in treatment or have a stable treatment plan. Those experiencing depressive symptoms and open to trying a new approach that includes exercise might find this trial suitable. As an unphased study, it offers a unique opportunity to explore innovative treatment combinations for depression.

Will I have to stop taking my current medications?

You can continue taking your current medications if you are on a stable treatment plan and are willing to maintain it throughout the study. If you are not currently on any mental health treatment, you can still participate.

What prior data suggests that this intervention approach is safe for individuals with depression?

Research has shown that Cognitive Behavioral Therapy (CBT), when done correctly, rarely causes unwanted effects. CBT is often as safe as taking medication for depression, and sometimes even safer. This study adds aerobic exercise to the therapy, which is generally safe for most people. Exercise is known to boost mood and usually has few negative side effects when done at a moderate pace. Therefore, the treatment in this trial is expected to be well-tolerated and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how incorporating physical activity and relaxation techniques before therapy sessions can enhance treatment for depression. The trial compares two strategies: one involves a 30-minute stationary bike exercise while watching nature documentaries, and the other involves simply watching the documentaries while resting. This approach is unique because it combines cognitive behavioral therapy (CBT) with physical exercise or relaxation, potentially boosting the mental health benefits beyond what standard CBT or medication alone can offer. By examining how these pre-therapy activities impact therapy outcomes, researchers hope to discover new ways to enhance the effectiveness of depression treatments.

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

Research has shown that Cognitive Behavioral Therapy (CBT) is usually effective for treating depression. Studies indicate that CBT can significantly reduce symptoms compared to regular care, with about 43% of people experiencing a 50% or greater decrease in their depression symptoms over time. In this trial, participants will be divided into different treatment arms to explore enhancements to CBT. One arm, ActiveCBT, involves participants completing a standardized 30-minute exercise session on a stationary bike before therapy. Another arm, CalmCBT, involves participants viewing a nature documentary while resting quietly before therapy. The study aims to determine whether moderate exercise before CBT sessions can enhance these benefits, as exercise might make therapy more effective by lifting mood and increasing engagement. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18-65 with Major Depressive Disorder (MDD), experiencing mild to severe depression, can join this study. They must be new to CBT and not currently pregnant or nursing. Participants should be physically able to exercise and not have a history of psychosis, mania, bipolar disorder, substance use disorders, or pose a risk of harm.

Inclusion Criteria

I have been diagnosed with major depression.

I am currently experiencing mild or more severe depression.

Either not engaging in any mental health treatment OR on a stable mental health treatment regimen and willing to maintain it for the length of the intervention

Exclusion Criteria

Diagnosed with current Substance Use Disorder, via the SCID

Diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID

My BMI is 40 or more, indicating severe obesity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 8 weekly sessions of CBT, with either moderate exercise (ActiveCBT) or quiet rest (CalmCBT) prior to therapy sessions.

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in depression symptoms and other outcomes after the treatment phase.

12 weeks

1 visit (in-person)

Long-term follow-up

Participants are assessed for long-term changes in depression symptoms and other outcomes.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• CBT+

Trial Overview The trial is testing two versions of CBT for depression: 'CalmCBT' involves resting before therapy sessions while 'ActiveCBT' includes moderate exercise beforehand. The goal is to see if exercising affects the benefits of CBT over eight weeks.

How Is the Trial Designed?

Group I: ActiveCBT Experimental Treatment 1 Intervention

Participants will complete a standardized 30-minute exercise session on a stationary bike prior to therapy. Participants will view one of 8 standardized 30-minute nature documentary videos while exercising.

Group II: CalmCBT Active Control 1 Intervention

Participants will view one of 8 standardized 30-minute nature documentary videos while resting quietly prior to therapy.

Who Is Running the Clinical Trial?

Iowa State University

Lead Sponsor

Trials

63

Recruited

145,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

Combined psychotherapy and pharmacotherapy for unipolar depression showed significantly better results than placebo treatments, indicating that both approaches together can enhance treatment effectiveness.

However, the combination of psychotherapy and medication was only slightly more effective than using either psychotherapy or pharmacotherapy alone, suggesting that while combined treatment is beneficial, it may not be dramatically superior to individual therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined psychotherapy and pharmacotherapy for depression. A systematic analysis of the evidence. Conte, HR., Plutchik, R., Wild, KV., et al.[2019]

Cognitive Behavioral Therapy (CBT) is an effective treatment for all levels of major depression, proving to be as effective and more durable than medication alone.

Combining CBT with medication can enhance treatment response and prolong benefits, especially when CBT is introduced after successful pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for depression. Sudak, DM.[2022]

Positive psychotherapy (PPT) focuses on enhancing positive emotions and engagement rather than just reducing depressive symptoms, showing significant long-term benefits, including a decrease in mild-to-moderate depression levels for up to a year in group settings.

In individual treatments for major depressive disorder, PPT resulted in higher remission rates compared to standard treatments and those combined with medication, suggesting it can be an effective supplement to traditional depression therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive psychotherapy. Seligman, MEP., Rashid, T., Parks, AC.[2022]

When cognitive behavioral therapy (CBT) is conducted effectively, the rate of adverse events is very low, comparable to or even lower than that of a placebo, indicating its safety and efficacy.

Many adverse events arise from poor-quality CBT due to therapists' insufficient training, highlighting the importance of regular patient assessments and supervision to ensure high standards in therapy delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. Okmaoto, Y., Jinnin, R., Yoshino, A., et al.[2018]

A review of 17 studies on combined psychotherapy and pharmacotherapy for depression suggests that this approach is not more effective than using either treatment alone, highlighting the need for further research due to methodological limitations.

However, combined treatment may offer specific benefits for certain subpopulations of depressed patients, indicating that personalized treatment strategies could be important in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of combined psychotherapy and pharmacotherapy in the treatment of depression. Manning, DW., Markowitz, JC., Frances, AJ.[2021]

In a study of 260 chronically depressed patients, those receiving Cognitive Behavioral Analysis System of Psychotherapy (CBASP) reported more severe adverse events compared to those receiving supportive psychotherapy, particularly in personal and occupational life.

However, CBASP was associated with fewer adverse events related to suicidal thoughts, suggesting that while it may lead to some temporary challenges, it can be a safer option in terms of suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression. Meister, R., Lanio, J., Fangmeier, T., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584580/

The Efficacy of Cognitive Behavioral Therapy: A Review ... The data supporting CBT for depression was less strong, but still in the medium effect size range across meta-analyses, with maintenance in 6-month follow-up ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... Within CBTs for depression specifically, a systematic review and meta-analysis showed that lower age, higher initial depression severity, individual treatment ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9840507/

Cognitive behavior therapy vs. control conditions, other ... CBT was found to be effective in depression when compared to control conditions such as usual care and waitlist, with a moderate to large ...

4. crowncounseling.com crowncounseling.com/statistics/cbt-success-rate-statistics/

CBT Success Rate Statistics: Effectiveness of CBT in 2024 43% of CBT patients report at least a 50% reduction in depression symptoms over 46 months, compared to 27% with usual care alone. Long-term ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-04547-9

Effectiveness of cognitive behavioural therapy-based ... CBT-based interventions for depression during the perinatal period appear effective, however results should be interpreted with caution.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06894641

Study Details | NCT06894641 | A Randomized Control ... This study is on a type of psychotherapy to treat depression in older adults called Cognitive Behavioural Therapy (CBT-OA). CBT is based on ...

7. withpower.com withpower.com/trial/phase-depression-8-2023-edae2

Enhanced Cognitive Behavioral Therapy for Depression · ... Research shows that when Cognitive Behavioral Therapy (CBT) is done correctly, it has a low rate of adverse events (unwanted effects), similar to or even less ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.