Addressing Depression and Anxiety Symptoms in Patients With Inflammatory Bowel Disease
- Conditions
- Crohn DiseaseDepressionAnxietyInflammatory Bowel DiseasesUlcerative Colitis
- Interventions
- Behavioral: Web-Based Cognitive Behavioral TherapyOther: Short QuestionnairesBehavioral: Nurse MonitoringOther: Detailed QuestionnairesOther: Screening Form
- Registration Number
- NCT03327038
- Lead Sponsor
- Mount Sinai Hospital, Canada
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychological Intervention Web-Based Cognitive Behavioral Therapy 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. Psychological Intervention Nurse Monitoring 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. Psychological Intervention Detailed Questionnaires 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. Psychological Intervention Screening Form 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. Control Detailed Questionnaires 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. Psychological Intervention Short Questionnaires 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. Control Screening Form 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.
- Primary Outcome Measures
Name Time Method Rates of Moderate Depression (PHQ-9) Post-Intervention (i.e. week 8) Post-intervention rates will be compared between study groups
Rates of Moderate Anxiety (GAD-7) Post-Intervention (i.e. week 8) Post-intervention rates will be compared between study groups
Rates of Moderate Depression (PHQ-9) and co-morbid Anxiety (GAD-7) Post-Intervention (i.e. week 8) Post-intervention rates will be compared between study groups
- Secondary Outcome Measures
Name Time Method Difference in Anxiety Scores (GAD-7) Post-Intervention (i.e. week 8) Post-intervention Generalized Anxiety Disorder (GAD-7) scores will be compared between study groups
Difference in Depression Scores (PHQ-9) Post-Intervention (i.e. week 8) Post-intervention Patient Health Questionnaire (PHQ-9) scores will be compared between study groups
Change in Depression Scores (PHQ-9) 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
Change in Anxiety Scores (GAD-7) 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
Rates of Active IBD (PRO-2 or MAYO-6) 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
Difference in Quality of Life Scores (SIBDQ) Post-Intervention (i.e. week 8) Post-intervention Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores will be compared between study groups
Rates of IBD-related hospitalizations Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8) Event rates over trial period will be compared between study groups
Rates of IBD-related surgery over intervention period Between Enrollment (i.e. week 1) and Post-intervention (i.e. week 8) Event rates over trial period will be compared between study groups
Difference in Patient Satisfaction Scores (CACHE) Post-Intervention (i.e. week 8) Post-intervention Patient Satisfaction with Health Care in IBD (CACHE) scores will be compared between study groups
Change in Patient Satisfaction Scores (CACHE) 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
Change in Quality of Life Scores (SIBDQ) 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
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada