Use of Cognitive Behavioral Therapy (CBT) or Sudarshan Kriya Yoga (SKY) for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)

Study Purpose

This is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with IBD can be improved with CBT compared to those treated with SKY.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - verified Crohn's disease.
  • - Crohn's patients on a stable treatment regimen with no evidence of active intestinal inflammation based on either normal c-reactive protein and/or fecal calprotectin, imaging studies, or endoscopy who meet the criteria for anxiety or depression based on the screening questionnaires.
  • - subjects who have been on stable doses of anxiety and/or depression medications (defined as no dose adjustment in the prior 12 weeks) at the screening visit who meet the criteria for anxiety and/or depression based on screening questionnaires and are willing to stay on the same dose of these medications throughout the study duration.
  • - may meet the criteria for both anxiety and depression and cohort assignment will be based on the survey with the highest scores suggesting more severe symptoms.

Exclusion Criteria:

  • - declines to participate for the full duration of the study.
  • - evidence of active intestinal inflammation based on an elevated c-reactive protein and/or fecal calprotectin, imaging studies or endoscopy.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05377840
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Yale University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jill Gaidos, MD, FACG
Principal Investigator Affiliation Yale University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Additional Details

This is a prospective, single center, randomized treatment study, where participants will be screened for anxiety and depression in a Crohn's disease population using the Generalized Anxiety Disorder (GAD) questionnaire and the Patient Health Questionnaire (PHQ). Participants with GAD scores of ≥8 will be considered to have anxiety and those with a PHQ score of ≥10 will be considered to have depression. All participants with screening questionnaire scores positive for anxiety or depression will be randomized to treatment with either cognitive behavioral therapy (CBT) or Sudarshan Kriya Yoga (SKY). Screening with GAD and PHQ will be repeated post treatment at weeks 6, 12 and 24. The primary objective of this study is to assess for an improvement in GAD and PHQ scores among subjects treated with CBT compared to those treated with SKY. The secondary objectives are to assess for improvements in health-related quality of life, based on short IBD Questionnaire scores; assess for improvement in pain scores, based on the Brief Pain Inventory Short Form; and assess for improvement in fatigue scores based on the FACIT-Fatigue Scale, among subjects with poor scores at baseline following treatment with CBT or SKY.

Arms & Interventions

Arms

Active Comparator: Cognitive Behavioral Therapy

Participants in this arm will participate in CBT to assess the impact it will have on anxiety or depression among patients with Crohn's disease

Experimental: Sudarshan Kriya Yoga

Participants in this arm will participate in SKY to assess the impact it will have on anxiety or depression among patients with Crohn's disease

Interventions

Behavioral: - Cognitive Behavioral Therapy

CBT is a combined psycho-social intervention that aims to improve overall mental health focusing on developing coping strategies. standard CBT Participants will have individual weekly sessions lasting 60 minutes each over an 8-week period with 1 follow-up maintenance session at week 12.

Behavioral: - Sudarshan Kriya Yoga

SKY Breath Meditation is a deep breathing and meditation technique that enables physiological changes leading to improved mental and physical health. Participants will first attend a 3-day online workshop (2.5 hours each day) delivered live by a certified instructor to learn the SKY Breath Meditation practice. Participants will then practice SKY 25 minutes daily for 6 weeks and 3-4 times per week up to 12 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale New Haven Hospital, New Haven, Connecticut

Status

Recruiting

Address

Yale New Haven Hospital

New Haven, Connecticut, 06520