Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease

April 14, 2018 updated by: Mount Sinai Hospital, Canada

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Recruiting
        • Mount Sinai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychological Intervention
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
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.
Active Comparator: Control
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Moderate Depression (PHQ-9)
Time Frame: Post-Intervention (i.e. week 8)
Post-intervention rates will be compared between study groups
Post-Intervention (i.e. week 8)
Rates of Moderate Anxiety (GAD-7)
Time Frame: Post-Intervention (i.e. week 8)
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)
Time Frame: Post-Intervention (i.e. week 8)
Post-intervention rates will be compared between study groups
Post-Intervention (i.e. week 8)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Geoffrey C Nguyen, MD, PhD, Mount Sinai Hospital (Toronto, ON, Canada)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 14, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADAPT-IBD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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