Cognitive Behavioral Therapy vs. Sudarshan Kriya Yoga for Depression in IBD
Recruiting in Palo Alto (17 mi)
Overseen byJill Gaidos, MD, FACG
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must be taking: Anxiety, Depression medications
Disqualifiers: Active inflammation, Suicidal ideation, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing if talk therapy (CBT) or yoga breathing exercises (SKY) can help reduce anxiety and depression in people with Crohn's disease. The study will compare the effects of these treatments on mental health, quality of life, pain, and fatigue. Yoga has several mechanisms that make it a promising treatment for depression and anxiety, including physical activity, behavioural activation, and mindfulness.
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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy vs. Sudarshan Kriya Yoga for Depression in IBD?
Research shows that Cognitive Behavioral Therapy (CBT) can help improve quality of life and reduce anxiety and depression in people with inflammatory bowel disease (IBD). A meta-analysis found that CBT significantly improved mental health and quality of life in IBD patients.
12345Is Cognitive Behavioral Therapy or Sudarshan Kriya Yoga safe for people with Inflammatory Bowel Disease?
Cognitive Behavioral Therapy and other non-drug treatments like mindfulness-based therapy and yoga have been studied in people with Inflammatory Bowel Disease and are generally considered safe. These therapies have shown positive effects on reducing anxiety and depression, which can improve quality of life.
13678How does Cognitive Behavioral Therapy (CBT) and Sudarshan Kriya Yoga differ from other treatments for depression in IBD?
Cognitive Behavioral Therapy (CBT) and Sudarshan Kriya Yoga are unique because they focus on changing thought patterns and incorporating breathing techniques, respectively, rather than using medication. CBT is a well-established treatment for depression that can be as effective as medication, while Sudarshan Kriya Yoga offers a holistic approach that may appeal to those seeking non-drug options.
910111213Eligibility Criteria
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.
+1 more
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
+1 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-administered Cognitive Behavioral TherapyExperimental Treatment1 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 TherapyActive Control1 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, Australia 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)
🇦🇺 Approved in Australia as Cognitive Behavioral Therapy for:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale New Haven HospitalNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
Crohn's & Colitis Foundation of America (CCFA)Collaborator
References
Does Computerized Cognitive Behavioral Therapy Help People with Inflammatory Bowel Disease? A Randomized Controlled Trial. [2018]Cognitive behavioral therapy may be useful for improving health-related quality of life (HRQOL) of at least some patients with inflammatory bowel disease (IBD), especially those with psychiatric comorbidities. However, cognitive behavioral therapy can be difficult to access. These difficulties can be overcome by computerized cognitive behavioral therapy (CCBT). This is a randomized controlled trial of a self-administered CCBT intervention for patients with IBD focused on improving HRQOL. It is hypothesized that CCBT completers will have an improved HRQOL relative to people not allocated to CCBT.
Effects of cognitive behavioral therapy on mental health and quality of life in inflammatory bowel disease patients: A meta-analysis of randomized controlled trials. [2023]We aim to assess the roles of cognitive behavioral therapy (CBT) in improving quality of life (QoL) and mental health in inflammatory bowel disease (IBD) patients. In this study, PubMed, Web of Science, PsycINfO, and the Cochrane Library databases were used for locating proper randomized controlled trials (RCTs) (to October 2022). IBD Questionnaire (IBDQ), Hospital Anxiety and Depression Scale-Anxiety Scale (HADS-A), and Hospital Anxiety and Depression Scale-Depression Scale (HADS-D) were selected for analysis. Finally, nine eligible RCTs were included in this study. The analysis of these RCTs showed that CBT significantly increased IBDQ scores (standardized mean difference (SMD): 0.26, 95% confidence interval (CI): [0.05, 0.47], p = 0.02), decreased HADS-A (SMD: -0.25, 95% CI: [-0.45, -0.05], p = 0.01), HADS-D (SMD: -0.17, 95% CI: [-0.31, -0.02], p = 0.02) scores. The result of subgroup analysis, based on treatment duration, showed that long-term CBT (≥ 12 weeks; SMD: 0.23, 95% CI: [0.05, 0.41]; p = 0.01; I2 = 28%) increased IBDQ scores. Thus, CBT is helpful for alleviating anxiety, depression and enhancing QoL in IBD patients.
Mindfulness-based cognitive therapy for inflammatory bowel disease patients: findings from an exploratory pilot randomised controlled trial. [2018]Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients; thus, IBD patients report higher rates of depression and anxiety than the general population. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms. There has been no randomized controlled trial (RCT) testing the use of MBCT in IBD patients. The purpose of this pilot study is to test the trial methodology and assess the feasibility of conducting a large RCT testing the effectiveness of MBCT in IBD.
Cognitive-Behavioural Therapy for Inflammatory Bowel Disease: 24-Month Data from a Randomised Controlled Trial. [2022]There is ongoing controversy on the effectiveness of psychotherapy in inflammatory bowel disease (IBD). In the few small studies, cognitive-behavioural therapy (CBT) has been shown to alleviate symptoms of anxiety or depression. However, there is little research on the impact of CBT on physical outcomes in IBD and no studies on long-term effectiveness of CBT.
Psychotherapy for inflammatory bowel disease: a review and update. [2022]Psychotherapy may be a useful intervention for inflammatory bowel disease (IBD) patients. We systematically reviewed all randomized controlled trials that have been performed in psychotherapy for inflammatory bowel disease patients.
Non-pharmacological Interventions for Anxiety and Depression in Adults With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. [2020]Objectives: To assess the published randomized controlled trials (RCT) of non-pharmacological interventions systematically and to synthesize the evidence of these interventions for the management of anxiety and depression in adults with inflammatory bowel disease (IBD). Background: Anxiety and depression are common symptoms in adults with IBD and can have many negative outcomes on their quality of life (QOL). Non-pharmacological interventions for anxiety and depression are important to improve the adaptive strategies of adults with IBD. Previously published reviews of non-pharmacological interventions to mitigate anxiety and depression in those with IBD have resulted in inconclusive evidence. This review is aimed to fill that gap. Design: Systematic review and meta-analysis. Method: Using a PRISMA diagram, English-language RCT published were searched using combined keywords of inflammatory bowel disease, Crohn's disease, ulcerative colitis, randomized controlled trial, anxiety, and depression. The Cochrane risk of bias tool is utilized to assess the methodological quality of each study. A meta-analysis of RCTs was conducted using Comprehensive Meta-Analysis (CMA) software. Results: The final review included 10 studies. The overall risk of bias of the selected studies varied from low risk in three studies, some concerns in four of the studies, and high risk of bias in three of the studies. Interventions included cognitive-behavioral therapy, mindfulness-based therapy, breath-body- mind -workshop, guided imagery with relaxation, solution-focused therapy, yoga, and multicomponent interventions. The pooled evidence from all non-pharmacological interventions showed that these interventions significantly helped to reduce anxiety, depression, and disease specific quality of life (QOL) in adults with IBD compared to control groups. However, the effect sizes are small. The pooled standardized mean difference (SMD) was -0.28 (95% CI [-0.47, -0.09], p = 0.004) for anxiety, -0.22 (95% CI [-0.41, -0.03], p = 0.025) for depression and 0.20 (95% CI [0.004, 0.39], p = 0.046) for disease specific QOL. Conclusion: The addressed non-pharmacological interventions were multifaceted and demonstrated positive effects on anxiety and depression, and QOL in those with IBD. Healthcare providers can facilitate a discussion with adults with IBD about the availability of these interventions to mitigate their anxiety and depression and to improve their QOL.
The physiological and psychological effects of cognitive behavior therapy on patients with inflammatory bowel disease before COVID-19: a systematic review. [2021]Cognitive behavioral therapy (CBT) is now included in the treatment of patients with inflammatory bowel disease (IBD) in many settings. However, different clinical trials report different outcomes without consensus. This study aims to evaluate the impact of CBT on the mental state, quality of life and disease activity of patients with IBD.
Mindfulness-based therapy for inflammatory bowel disease patients with functional abdominal symptoms or high perceived stress levels. [2022]Psychological interventions are used in patients with inflammatory bowel disease (IBD) but there is uncertainty about who the optimal target population is. Multi-convergent therapy (MCT) is a form of psychotherapy that combines mindfulness meditation with aspects of cognitive behavioural therapy and has been used in the management of irritable bowel syndrome (IBS). This study aimed to assess the feasibility and efficacy of MCT in the management of IBD patients with either functional abdominal symptoms or high perceived stress levels.
Treating depression with the evidence-based psychotherapies: a critique of the evidence. [2018]While Cognitive Behaviour Therapy (CBT) and Interpersonal Therapy (IPT) have been positioned as first-line evidence-based treatments for depression, we suggest that limitations to the 'evidence' deserve wider appreciation.
Interpersonal Psychotherapy Versus Cognitive Therapy for Depression: How They Work, How Long, and for Whom-Key Findings From an RCT. [2022]Although the effectiveness of interpersonal psychotherapy (IPT) and cognitive therapy (CT) for major depression has been established, little is known about how and for whom they work and how they compare in the long term. The latter is especially relevant for IPT because research on its long-term effects has been limited. This overview paper summarizes findings from a Dutch randomized controlled trial on the effects and mechanisms of change of IPT versus CT for major depression.
Behavioural activation delivered by the non-specialist: phase II randomised controlled trial. [2018]Behavioural activation appears as effective as cognitive-behaviour therapy (CBT) in the treatment of depression. If equally effective, then behavioural activation may be the preferred treatment option because it may be suitable for delivery by therapists with less training. This is the first randomised controlled trial to look at this possibility.
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. [2023]The health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive-behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies.
Cognitive therapy for depression: conceptual issues and clinical efficacy. [2019]Cognitive therapy has emerged as 1 of the most promising psychosocial interventions for the treatment of depression. It appears to be at least the equal of alternative interventions (including pharmacotherapy) with respect to acute treatment. In addition, there are indications that it may reduce risk of symptom return after treatment termination. Nonetheless, design limitations reduce the certainty with which such conclusions can be drawn. Furthermore, tests of its efficacy have largely been limited to nonbipolar outpatient (or subclinical) samples. At this time, cognitive therapy is best considered a promising, but as yet not adequately tested, intervention for the treatment of depression.