Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease

Depression Clinical Trial

Official title:

Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease (ADAPT-IBD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327038
• Other study ID #: ADAPT-IBD
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2017
• Last updated: April 14, 2018
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2018
• Source: Mount Sinai Hospital, Canada
• Contact: Geoffrey C Nguyen, MD, PhD
• Phone: (416) 586-4800
• Email: geoff.nguyen[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inflammatory Bowel Diseases (IBD) are chronic debilitating disorders of the gastrointestinal tract that comprise two subtypes; Crohn's Disease (CD) and Ulcerative Colitis (UC). Canada has among the highest incidence rates of CD and UC in the world, as high as 20.2 and 19.5 per 100,000 respectively. Although, IBD can occur at any age, it is frequently diagnosed in the second and third decades of life, at a time when vulnerable individuals are entering the prime years of their lives. This age of onset, coupled with the recurrent and frequently relapsing nature of these disorders, can significantly impair the psychological well-being of patients. Therefore, it's not surprising that patients with IBD report a higher burden of depression and anxiety in comparison to the general population. The prevalence of depression and anxiety in patients with IBD have previously been linked to the following: (1) Increased risk of surgery; (2) Increased number of relapses; (3) Clinical recurrence; (4) Treatment failure and earlier retreatment; (5) Lower self-reported quality of life, satisfaction, and medication adherence; (6) and Increased health care utilization. Although, depression and anxiety are highly treatable conditions, they are often under-recognized and under- treated in patients with IBD. The most common treatments for these disorders are pharmacological agents and psychological treatments. Psychological treatments like Cognitive Behavioral Therapy (CBT) have extensive support for treatment of depression and anxiety. The major advantage of psychological treatments over pharmacological agents is their ability to sustain improved depression and anxiety symptoms in patients post-treatment. As part of this study, we aim to evaluate the following:

Specific Aim #1: Determine whether a psychological intervention, involving web-based CBT, is effective in ameliorating depression and anxiety symptoms in a cohort of adult IBD patients.

Specific Aim #2: Determine the durability effect of the intervention on sustaining improved psychiatric symptoms.

Specific Aim #3: Determine the impact of a psychological on IBD-specific and psychiatric-specific health care utilization.

Description:

Inflammatory Bowel Diseases (IBD) are chronic debilitating disorders of the gastrointestinal tract that comprise two subtypes; Crohn's Disease (CD) and Ulcerative Colitis (UC). Canada has among the highest incidence rates of CD and UC in the world, as high as 20.2 and 19.5 per 100,000 respectively. Although, IBD can occur at any age, it is frequently diagnosed in the second and third decades of life; at a time when vulnerable individuals are entering the prime years of their lives. This age of onset, coupled with the recurrent and frequently relapsing nature of these disorders, can significantly impair the psychological well-being of patients. Therefore, it's not surprising that patients with IBD report a higher burden of depression and anxiety in comparison to the general population.

The rates of depression in patients with IBD, as measured by the National Population Health Survey and the Canadian Community Health Survey, range from 14.7% to 16.3%. These rates are significantly higher than the general Canadian population, in which 5.6% of healthy respondents reported a 12-month prevalence of depression. Moreover, studies among clinical samples of IBD patients have reported rates of depression as high as 35%. The prevalence of depression and anxiety in patients with IBD have previously been linked to the following: (1) Increased risk of surgery; (2) Increased number of relapses; (3) Clinical recurrence; (4) Treatment failure and earlier retreatment; (5) Lower self-reported quality of life, satisfaction, and medication adherence; (6) and Increased health care utilization.

Although, depression and anxiety are highly treatable conditions, they are often under recognized and under treated in patients with IBD. The most common treatments for these disorders are pharmacological agents and psychological treatments. Psychological treatments like Cognitive Behavioral Therapy (CBT) have extensive support for treatment of depression and anxiety. CBT refers to a group of interventions that share the notion that cognitive factors influence mental disorders and psychological distress, and that maladaptive cognitions contribute to emotional distress and behavioral problems. The major advantage of psychological treatments over pharmacological agents is their ability to sustain improved depression and anxiety symptoms in patients post-treatment.

Considering the prevalence and impact of depression and anxiety disorders in patients with IBD, further research in this area is needed to identify the most effective approaches for screening and treatment of these disorders. Research is also need to ascertain the effects of psychological treatments for depression and anxiety on influencing physiological aspects of IBD. As part of this study, we aim to evaluate the effectiveness of a psychological intervention which incorporates web-based CBT intervention on a cohort of adult IBD patients; by measuring its impact on clinical and self-reported outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 1, 2020
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PHQ-9 AND/OR GAD-7 score = 10

• Confirmed diagnosis of IBD (based on record of diagnostic endoscopy)

• Access to Computer or Smartphone

• Access to an Internet Connection

Exclusion Criteria:

• Patients without a record of diagnostic endoscopy in their clinical record

• Under psychological treatment parallel to the intervention being carried out

• Diagnosis of major depressive, dysthymic, bipolar or psychotic disorder

• History of anti-depressant medication use within 1 month of enrollment

• History of substance abuse or dependence within 1 month of enrollment

• Previous course of CBT within 12 months of Enrollment

• History of suicide

• History of psychiatric hospitalization

• Inability to provide informed consent

• Insufficient command of written and spoken English

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Colitis, Ulcerative
• Crohn Disease
• Depression
• Depressive Disorder
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Behavioral:
• Web-Based Cognitive Behavioral Therapy
Patients will receive access to a 5-week web-based CBT program entitled 'Mood Gym'. The program is derived from traditional, therapist-directed cognitive behavioral therapy. The program consists of 5 modules, and patients will asked to complete 1 module per week over, during weeks 2-6 over their intervention period.

Other:
• Short Questionnaires
Patients will receive emails to complete bi-weekly, web-based questionnaires at weeks 2, 4, and 6 of their intervention period. The short questionnaires will ask to patients to self-report their Depression (PHQ-9) and Anxiety (GAD-7) symptoms; along with their Crohn's Disease activity (PRO-2) or Ulcerative Colitis Disease Activity (MAYO-6).

Behavioral:
• Nurse Monitoring
Patient responses to the short questionnaires will be monitored by an IBD advanced practice nurse. The IBD nurse will determine if there are elevations in anxiety, depression, and disease activity over the intervention period. Based on patient responses to the short questionnaires, the nurse will follow-up with patients via email or telephone to address patient symptoms. If there are clinically important changes in the patients' disease activity the nurse may also arrange for the patients to receive expedited outpatient follow-up with their gastroenterologist.

Other:
• Detailed Questionnaires
Patients will complete a detailed questionnaires at enrollment (i.e. week 1 of enrollment) and also at post-intervention (i.e. week 8 of enrollment). The enrollment questionnaire will query the patients Ulcerative Colitis Disease Activity (MAYO-6) or Crohn's Disease Activity (PRO-2); Quality of Life (SIBDQ); and Patient Satisfaction with Health Care in IBD (CACHE). The post-intervention questionnaire will query the same information as the enrollment questionnaire but will also ask patients to self-report their depression (PHQ-9) and anxiety (GAD-7) symptoms.Quality of Life will be measured using the 10 item Short Inflammatory Bowel Disease Questionnaire (SIBDQ), which has a total score range of 10 to 70, with higher scores indicating better quality of life. Patient Satisfaction with Health Care in IBD will be measured using the 32 item CACHE Questionnaire, which scores from 0 -least satisfaction to 100-highest satisfaction.
• Screening Form
Patients will complete a screening form at routine IBD outpatient visits to Mount Sinai Hospital to self-report their depression and generalized anxiety symptoms. Their depression symptoms will be reported on the 9-item Patient Health Questionnaire (PHQ-9), which has a total score ranging from 0 to 27, with scores of 5, 10, 15 and 20 representing cut points for mild, moderate, moderately severe, and severe depression. Their generalized anxiety symptoms will be reported on the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7), which has a total score ranging from 0 to 21, with scores of 5, 10, and 15 representing cut points for mild, moderate, and severe anxiety. Patients who self-report scores of moderate depression AND/OR moderate anxiety will be eligible to participate in this study.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Bernstein CN, Wajda A, Svenson LW, MacKenzie A, Koehoorn M, Jackson M, Fedorak R, Israel D, Blanchard JF. The epidemiology of inflammatory bowel disease in Canada: a population-based study. Am J Gastroenterol. 2006 Jul;101(7):1559-68. Erratum in: Am J Gastroenterol. 2006 Aug;101(8):1945. — View Citation

Fiest KM, Walker JR, Bernstein CN, Graff LA, Zarychanski R, Abou-Setta AM, Patten SB, Sareen J, Bolton JM, Marriott JJ, Fisk JD, Singer A, Marrie RA; CIHR Team Defining the Burden and Managing the Effects of Psychiatric Comorbidity in Chronic Immunoinflammatory Disease. Systematic review and meta-analysis of interventions for depression and anxiety in persons with multiple sclerosis. Mult Scler Relat Disord. 2016 Jan;5:12-26. doi: 10.1016/j.msard.2015.10.004. Epub 2015 Oct 19. Review. — View Citation

Fuller-Thomson E, Sulman J. Depression and inflammatory bowel disease: findings from two nationally representative Canadian surveys. Inflamm Bowel Dis. 2006 Aug;12(8):697-707. — View Citation

Graff LA, Walker JR, Bernstein CN. Depression and anxiety in inflammatory bowel disease: a review of comorbidity and management. Inflamm Bowel Dis. 2009 Jul;15(7):1105-18. doi: 10.1002/ibd.20873. Review. — View Citation

Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. Epub 2012 Jul 31. — View Citation

Sajadinejad MS, Asgari K, Molavi H, Kalantari M, Adibi P. Psychological issues in inflammatory bowel disease: an overview. Gastroenterol Res Pract. 2012;2012:106502. doi: 10.1155/2012/106502. Epub 2012 Jun 21. — View Citation

Szigethy E, Kenney E, Carpenter J, Hardy DM, Fairclough D, Bousvaros A, Keljo D, Weisz J, Beardslee WR, Noll R, DeMaso DR. Cognitive-behavioral therapy for adolescents with inflammatory bowel disease and subsyndromal depression. J Am Acad Child Adolesc Psychiatry. 2007 Oct;46(10):1290-8. — View Citation

Yanartas O, Kani HT, Bicakci E, Kilic I, Banzragch M, Acikel C, Atug O, Kuscu K, Imeryuz N, Akin H. The effects of psychiatric treatment on depression, anxiety, quality of life, and sexual dysfunction in patients with inflammatory bowel disease. Neuropsychiatr Dis Treat. 2016 Mar 24;12:673-83. doi: 10.2147/NDT.S106039. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of Moderate Depression (PHQ-9)	Post-intervention rates will be compared between study groups	Post-Intervention (i.e. week 8)
Primary	Rates of Moderate Anxiety (GAD-7)	Post-intervention rates will be compared between study groups	Post-Intervention (i.e. week 8)
Primary	Rates of Moderate Depression (PHQ-9) and co-morbid Anxiety (GAD-7)	Post-intervention rates will be compared between study groups	Post-Intervention (i.e. week 8)
Secondary	Difference in Depression Scores (PHQ-9)	Post-intervention Patient Health Questionnaire (PHQ-9) scores will be compared between study groups	Post-Intervention (i.e. week 8)
Secondary	Difference in Anxiety Scores (GAD-7)	Post-intervention Generalized Anxiety Disorder (GAD-7) scores will be compared between study groups	Post-Intervention (i.e. week 8)
Secondary	Change in Depression Scores (PHQ-9)	Change in Patient Health Questionnaire (PHQ-9) scores between enrollment and post-intervention will be compared within study groups	Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Secondary	Change in Anxiety Scores (GAD-7)	Change in Generalized Anxiety Disorder (GAD-7) scores between enrollment and post-intervention will be compared within study groups	Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Secondary	Rates of Active IBD (PRO-2 or MAYO-6)	Post-intervention rates will be compared between study groups	Post-Intervention (i.e. week 8)
Secondary	Rates of Active IBD (PRO-2 or MAYO-6)	Change in rates between enrollment and post-intervention will be compared within study groups	Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Secondary	Difference in Quality of Life Scores (SIBDQ)	Post-intervention Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores will be compared between study groups	Post-Intervention (i.e. week 8)
Secondary	Difference in Patient Satisfaction Scores (CACHE)	Post-intervention Patient Satisfaction with Health Care in IBD (CACHE) scores will be compared between study groups	Post-Intervention (i.e. week 8)
Secondary	Change in Quality of Life Scores (SIBDQ)	Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores between enrollment and post-intervention will be compared within study groups	Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Secondary	Change in Patient Satisfaction Scores (CACHE)	Change in Patient Satisfaction with Health Care in IBD (CACHE) scores between enrollment and post-intervention will be compared within study groups	Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Secondary	Rates of IBD-related hospitalizations	Event rates over trial period will be compared between study groups	Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Secondary	Rates of IBD-related surgery over intervention period	Event rates over trial period will be compared between study groups	Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)