Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease

NCT03327038 | Unknown

• 1 other identifier: ADAPT-IBD
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• Rates of Moderate Depression (PHQ-9)

  Post-intervention rates will be compared between study groups

  Post-Intervention (i.e. week 8)

• Rates of Moderate Anxiety (GAD-7)

  Post-intervention rates will be compared between study groups

  Post-Intervention (i.e. week 8)

• 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 Outcomes (12)

• Difference in Depression Scores (PHQ-9)

  Post-Intervention (i.e. week 8)

• Difference in Anxiety Scores (GAD-7)

  Post-Intervention (i.e. week 8)

• Change in Depression Scores (PHQ-9)

  Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)

• Change in Anxiety Scores (GAD-7)

  Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)

• Rates of Active IBD (PRO-2 or MAYO-6)

  Post-Intervention (i.e. week 8)

Study Arms (2)

Psychological Intervention

EXPERIMENTAL

Patients will be randomized to the intervention group after they have complete the study screening form. Patients randomized to the intervention group will receive a multifaceted intervention consisting of the following components (administered over an 8 week period): (1) Web-Based Cognitive Behavioral Therapy: (2) Short Questionnaires; (3) Ongoing Nurse Monitoring.

Behavioral: Web-Based Cognitive Behavioral Therapy; Other: Short Questionnaires; Behavioral: Nurse Monitoring; Other: Detailed Questionnaires; Other: Screening Form

Control

ACTIVE COMPARATOR

Patients will be randomized to the control group after they have completed the study screening form. Patients randomized to the control group will receive the usual standard of care that is available to patients with moderate anxiety or depression. Additionally, control patients will completed detailed questionnaires for assessment of primary and secondary outcomes.

Other: Detailed Questionnaires; Other: Screening Form

Interventions

Web-Based Cognitive Behavioral Therapy BEHAVIORAL

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.

Psychological Intervention

Short Questionnaires OTHER

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).

Psychological Intervention

Nurse Monitoring BEHAVIORAL

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.

Psychological Intervention

Detailed Questionnaires OTHER

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.

Control; Psychological Intervention

Screening Form OTHER

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.

Control; Psychological Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Publications (9)

• 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.

  PMID: 27069364 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2006.00603.x.

  PMID: 16863561 BACKGROUND

• 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.

  PMID: 19161177 BACKGROUND

• 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.

  PMID: 22778720 BACKGROUND

• 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.

  PMID: 26856938 BACKGROUND

• 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. doi: 10.1097/00054725-200608000-00005.

  PMID: 16917224 BACKGROUND

• 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. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.

  PMID: 23459093 BACKGROUND

• 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):1290-1298. doi: 10.1097/chi.0b013e3180f6341f.

  PMID: 17885570 BACKGROUND

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Geoffrey C Nguyen, MD, PhD

  Mount Sinai Hospital (Toronto, ON, Canada)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey C Nguyen, MD, PhD

CONTACT

(416) 586-4800; geoff.nguyen@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: October 31, 2017
• Study Start: January 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

CA (1)