Cognitive Behavioral Therapy vs. Sudarshan Kriya Yoga for Depression in IBD

Overseen By Jill Gaidos, MD, FACG

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Anxiety, Depression medications

Disqualifiers: Active inflammation, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: 7

Duration: 24 weeks

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two approaches to help individuals with anxiety or depression related to inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. One group will receive Cognitive Behavioral Therapy (CBT) guided by a psychologist, while another will learn CBT independently using a book. A third group will practice Sudarshan Kriya Yoga, a type of breathing exercise and yoga. The trial seeks participants with IBD who have stable symptoms and experience anxiety or depression. Participants must maintain their current mental health medication doses throughout the study. As an unphased trial, this study provides a unique opportunity to explore innovative therapies for managing anxiety and depression in IBD patients.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications. Participants need to stay on the same dose of their anxiety and/or depression medications throughout the study.

What prior data suggests that these treatments are safe for individuals with IBD?

Research has shown that Cognitive Behavioral Therapy (CBT) effectively helps people change negative thinking patterns. Studies indicate that it is generally safe and well-tolerated, with no significant side effects or risks reported. CBT assists individuals in managing issues like anxiety and depression by teaching new coping strategies.

Although this specific trial lacks a detailed description, the common use of CBT for mental health conditions can reassure participants of its safety. In this trial, participants will either attend CBT sessions with a psychologist or use a self-guided book. Both methods aim to improve mental health in individuals with inflammatory bowel disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore different approaches to managing depression in patients with inflammatory bowel disease (IBD). While traditional treatments typically involve medication and psychotherapy, these trials investigate the potential of Cognitive Behavioral Therapy (CBT) in two distinct formats: psychologist-administered and self-administered. The self-administered CBT is particularly intriguing as it empowers patients to manage their mental health independently, potentially increasing accessibility and reducing treatment costs. Additionally, Sudarshan Kriya Yoga, a form of rhythmic breathing, offers a non-pharmacological option that could complement existing therapies by addressing both mental and physical well-being through stress reduction and improved emotional balance.

What evidence suggests that these treatments could be effective for depression in IBD?

Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, can effectively treat depression and anxiety. It achieves this by teaching individuals to recognize and change negative thought patterns. Studies have found that CBT helps manage mental health issues by reducing behaviors that exacerbate these conditions.

For Sudarshan Kriya Yoga (SKY), another treatment option in this trial, direct research is limited. However, yoga and similar practices are known to enhance mental well-being by promoting relaxation and reducing stress. This suggests that SKY might positively affect depression and anxiety, but further research is necessary to confirm this. ^{3 4 6 7 8}

Who Is on the Research Team?

Jill Gaidos, MD, FACG

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals with Crohn's disease who are stable on anxiety or depression meds, without dose changes in the last 12 weeks. They should not have active intestinal inflammation and must commit to the full study duration. Non-English speakers, those with severe mental illness, or active inflammation are excluded.

Inclusion Criteria

I have been diagnosed with Crohn's disease.

I may have both anxiety and depression, with one being more severe.

I have Crohn's with no current inflammation and anxiety or depression.

Exclusion Criteria

I am not willing to participate in the study for its full duration.

Non-English speaker

Any subject who expresses suicidal ideation or has severe mental illness as they will be taken to the emergency room for urgent psychiatric care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive either psychologist-administered CBT or self-administered CBT for anxiety and depression

24 weeks

Weekly virtual visits for psychologist-administered CBT

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Assessments at weeks 6, 12, 24, and 52

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy
• Sudarshan Kriya Yoga

Trial Overview The study aims to see if Cognitive Behavioral Therapy (CBT) or Sudarshan Kriya Yoga (SKY) can improve anxiety and depression in people with Inflammatory Bowel Disease (IBD). Participants will be randomly assigned to either CBT or SKY treatment groups.

How Is the Trial Designed?

Group I: Self-administered Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Participants in this arm will be given a patient education book that teaches how to self-administer cognitive behavioral therapy to assess the impact it will have on anxiety or depression among patients with inflammatory bowel disease

Group II: Psychologist-administered Cognitive Behavioral Therapy Active Control 1 Intervention

Participants in this arm will participate in psychologist-administered CBT to assess the impact it will have on anxiety or depression among patients with inflammatory bowel disease

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Crohn's & Colitis Foundation of America (CCFA)

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

A randomized controlled trial involving 47 participants showed that behavioral activation is significantly more effective than treatment as usual in reducing depression symptoms, with a notable improvement on the Beck Depression Inventory-II.

The study suggests that behavioral activation can be effectively delivered by generic mental health workers, making it a potentially accessible treatment option for depression that requires less specialized training than cognitive-behavioral therapy (CBT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. Ekers, D., Richards, D., McMillan, D., et al.[2018]

Cognitive-behavioral therapy (CBT) did not significantly impact disease activity or physical health outcomes in patients with inflammatory bowel disease (IBD) after 24 months, based on a randomized controlled trial comparing CBT plus standard care to standard care alone.

The study found no significant improvements in mental health, coping, or quality of life for participants receiving CBT, suggesting that future research may need to explore more personalized approaches to psychotherapy for IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioural Therapy for Inflammatory Bowel Disease: 24-Month Data from a Randomised Controlled Trial. Mikocka-Walus, A., Bampton, P., Hetzel, D., et al.[2022]

The Resilience Training App Version 2, designed for guided internet cognitive-behavioral therapy (iCBT), will be tested in a study involving 3520 participants with subthreshold depression to determine the short-term efficacy of five different CBT skills in reducing depressive symptoms.

The study aims to identify which specific CBT skills are most effective for different individuals and will also explore the long-term effectiveness of these skills in preventing major depressive episodes over a 50-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four 2×2 factorial trials of smartphone CBT to reduce subthreshold depression and to prevent new depressive episodes among adults in the community-RESiLIENT trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a master protocol. Furukawa, TA., Tajika, A., Sakata, M., et al.[2023]

Cognitive Behaviour Therapy (CBT) and Interpersonal Therapy (IPT) are commonly regarded as top treatments for depression, but their effectiveness may not be as universally applicable as previously thought, according to a systematic review.

The review highlights that the specific benefits of CBT and IPT for depression need further investigation, suggesting that these therapies may work better in certain contexts rather than for all patients with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating depression with the evidence-based psychotherapies: a critique of the evidence. Parker, G., Fletcher, K.[2018]

Cognitive behavioral therapy (CBT) has been found to improve the quality of life and reduce depression and anxiety in patients with inflammatory bowel disease (IBD) in the short term, based on a systematic review of 11 randomized controlled trials.

However, the benefits of CBT on mental health were not sustained over time, and there is insufficient evidence to suggest that CBT affects disease activity or C-reactive protein levels in IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The physiological and psychological effects of cognitive behavior therapy on patients with inflammatory bowel disease before COVID-19: a systematic review. Chen, J., Chen, X., Sun, Y., et al.[2021]

Cognitive Behavioral Therapy (CBT) significantly improves quality of life in patients with inflammatory bowel disease (IBD), as indicated by increased IBD Questionnaire scores in a review of nine randomized controlled trials.

CBT also effectively reduces anxiety and depression levels in IBD patients, with significant decreases in Hospital Anxiety and Depression Scale scores, particularly with long-term treatment (≥ 12 weeks).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cognitive behavioral therapy on mental health and quality of life in inflammatory bowel disease patients: A meta-analysis of randomized controlled trials. Wang, C., Sheng, Y., Yu, L., et al.[2023]

This pilot study involving 44 IBD patients suggests that Mindfulness-based Cognitive Therapy (MBCT) can significantly improve depression, anxiety, and mindfulness scores compared to a wait-list control group, indicating its potential effectiveness for managing mental health in IBD patients.

The study also highlights the feasibility of conducting a larger randomized controlled trial (RCT) to further test MBCT's effectiveness, although it noted a high dropout rate of 44% and a recruitment rate of only 15%, suggesting the need for protocol adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for inflammatory bowel disease patients: findings from an exploratory pilot randomised controlled trial. Schoultz, M., Atherton, I., Watson, A.[2018]

A systematic review of 18 studies on psychotherapy for inflammatory bowel disease (IBD) patients found that while it had minimal impact on anxiety, depression, and quality of life, it showed promise in reducing pain, fatigue, relapse rates, and hospitalizations.

Psychotherapy may improve medication adherence and could be cost-effective for IBD patients, but the overall effects are mixed, indicating a need for further research to identify the most effective types of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychotherapy for inflammatory bowel disease: a review and update. McCombie, AM., Mulder, RT., Gearry, RB.[2022]

A randomized controlled trial involving 199 patients with inflammatory bowel disease (IBD) showed that those who completed a self-administered computerized cognitive behavioral therapy (CCBT) program had significant improvements in health-related quality of life (HRQOL) and mental health scores at 12 weeks compared to those receiving usual treatment.

However, these improvements were not sustained at 6 months, and factors such as baseline depression and lower initial HRQOL scores were linked to higher dropout rates, suggesting that CCBT may not be effective for all IBD patients, particularly those with comorbid depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Computerized Cognitive Behavioral Therapy Help People with Inflammatory Bowel Disease? A Randomized Controlled Trial. McCombie, A., Gearry, R., Andrews, J., et al.[2018]

In a study involving 182 adult outpatients with major depression, both interpersonal psychotherapy (IPT) and cognitive therapy (CT) were found to be more effective than a waitlist control, with no significant differences in outcomes between the two therapies over a follow-up period of up to 17 months.

The study suggests that while IPT and CT are similarly effective, the mechanisms through which they produce change may differ, indicating a need for more personalized treatment approaches to identify which therapy may be more beneficial for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpersonal Psychotherapy Versus Cognitive Therapy for Depression: How They Work, How Long, and for Whom-Key Findings From an RCT. Lemmens, LHJM., van Bronswijk, SC., Peeters, FPML., et al.[2022]

A systematic review of 10 randomized controlled trials found that non-pharmacological interventions, such as cognitive-behavioral therapy and yoga, significantly reduced anxiety and depression in adults with inflammatory bowel disease (IBD), although the effect sizes were small.

These interventions also positively impacted disease-specific quality of life (QOL), suggesting that healthcare providers should discuss these options with patients to help manage their mental health and improve overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacological Interventions for Anxiety and Depression in Adults With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. Davis, SP., Bolin, LP., Crane, PB., et al.[2020]

Cognitive therapy is a promising psychosocial intervention for treating depression, showing effectiveness comparable to other treatments like medication in acute cases.

While cognitive therapy may help reduce the risk of symptoms returning after treatment, its efficacy has mainly been tested in nonbipolar outpatient samples, indicating a need for further research to confirm its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy for depression: conceptual issues and clinical efficacy. Hollon, SD., Shelton, RC., Davis, DD.[2019]

In a study of 66 patients with inflammatory bowel disease (IBD), multi-convergent therapy (MCT) showed potential benefits in improving quality of life, particularly for those with IBS-type symptoms, as indicated by a significant increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores compared to controls.

While the overall improvement in IBDQ scores for the MCT group was not statistically significant, patients with IBS-type symptoms experienced a notable increase in scores, suggesting that targeting these symptoms with MCT could be a promising approach, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy for inflammatory bowel disease patients with functional abdominal symptoms or high perceived stress levels. Berrill, JW., Sadlier, M., Hood, K., et al.[2022]

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