Clinical trial NCT03327038: Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease
Official title: Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease (ADAPT-IBD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Depression
Anxiety
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of Moderate Depression (PHQ-9)
timeFrame: Post-Intervention (i.e. week 8)
measure: Rates of Moderate Anxiety (GAD-7)
timeFrame: Post-Intervention (i.e. week 8)
measure: Rates of Moderate Depression (PHQ-9) and co-morbid Anxiety (GAD-7)
timeFrame: Post-Intervention (i.e. week 8)
Secondary outcomes:
measure: Difference in Depression Scores (PHQ-9)
timeFrame: Post-Intervention (i.e. week 8)
measure: Difference in Anxiety Scores (GAD-7)
timeFrame: Post-Intervention (i.e. week 8)
measure: Change in Depression Scores (PHQ-9)
timeFrame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
measure: Change in Anxiety Scores (GAD-7)
timeFrame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
measure: Rates of Active IBD (PRO-2 or MAYO-6)
timeFrame: Post-Intervention (i.e. week 8)
measure: Rates of Active IBD (PRO-2 or MAYO-6)
timeFrame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
measure: Difference in Quality of Life Scores (SIBDQ)
timeFrame: Post-Intervention (i.e. week 8)
measure: Difference in Patient Satisfaction Scores (CACHE)
timeFrame: Post-Intervention (i.e. week 8)
measure: Change in Quality of Life Scores (SIBDQ)
timeFrame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
measure: Change in Patient Satisfaction Scores (CACHE)
timeFrame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
measure: Rates of IBD-related hospitalizations
timeFrame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
measure: Rates of IBD-related surgery over intervention period
timeFrame: Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital (Toronto, ON, Canada)
name: Geoffrey C Nguyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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