← Back to Search

Psychological Intervention for Depression

N/A
Waitlist Available
Led By Geoffrey C Nguyen, MD, PhD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between enrollment (i.e. week 1) and post-intervention (i.e. week 8)
Awards & highlights

Study 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.

Eligible Conditions
  • Depression
  • Ulcerative Colitis
  • Anxiety
  • Inflammatory Bowel Disease
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between enrollment (i.e. week 1) and post-intervention (i.e. week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and between enrollment (i.e. week 1) and post-intervention (i.e. week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rates of Moderate Anxiety (GAD-7)
Rates of Moderate Depression (PHQ-9)
Rates of Moderate Depression (PHQ-9) and co-morbid Anxiety (GAD-7)
Secondary outcome measures
Change in Anxiety Scores (GAD-7)
Change in Depression Scores (PHQ-9)
Change in Patient Satisfaction Scores (CACHE)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Psychological InterventionExperimental Treatment5 Interventions
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.
Group II: ControlActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,448 Total Patients Enrolled
8 Trials studying Depression
1,830 Patients Enrolled for Depression
Geoffrey C Nguyen, MD, PhDPrincipal InvestigatorMount Sinai Hospital (Toronto, ON, Canada)
1 Previous Clinical Trials
220 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~22 spots leftby Apr 2025