Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease

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

Interventions

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.

OTHER

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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada

  lead OTHER

Principal Investigators

• Geoffrey C Nguyen, MD, PhD · Mount Sinai Hospital (Toronto, ON, Canada)

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2019-05-01

Completion

2020-01-01

Countries

• Canada

Study Locations