IBDclinic: A validation trial of the world’s first evidence-based, automated, online program for the assessment and treatment of inflammatory bowel disease (IBD)-associated anxiety and depression.

Not Applicable

• Conditions: Inflammatory Bowel Disease; Depression; Anxiety; Oral and Gastrointestinal - Inflammatory bowel disease; Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12612000820808
• Lead Sponsor: The BROAD foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Individuals attending an IBD outpatient clinics in Melbourne will be recruited into this study. Additional inclusion criteria are: (a) age over 18 years and ability to provide written informed consent; (b) a primary diagnosis of Major Depressive Disorder (MDD), Panic Disorder (PD) Social Anxiety Disorder (SAD), Generalised Anxiety Disorder (GAD); not currently receiving psychological treatment for MDD, PD, SAD, GAD (c) if using steroidal medication, must have been maintained on a stable dose for at least three months and must maintain constant dose throughout the course of the study; and (d) access to internet-enabled computer

Exclusion Criteria

Exclusion criteria are: a) severe depression (as determined by initial gastroenterologist review or by ePASS) and/or suicide risk requiring immediate treatment; (b) primary diagnosis of a DSM-IV disorder other than MDE, PD, SAD, or GAD; (c) current use of psychotropic medication (e.g., anti-depressant or anxiolytic); and (d) indeterminate IBD. People who do not meet criteria, yet require further assistance, will be referred back to their consulting gastroenterologist, GP, or relevant mental health service.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: Difference in rating on ePASS of anxiety or depression between the treatment as usual and IBDclinic intervention groups.<br><br>e-PASS is broken up into a series of modules and each module assesses for a particular mental health condition (e.g., Panic Disorder). Depending on how you answer the questions in each module, you will either be asked to continue to complete more questions or you will by-pass that particular module and jump to the next one that assesses for another mental health condition (e.g., Social Anxiety Disorder). This process continues until you reach the last module. Once completed e-PASS will automatically generate a feedback summary form that will provide you with the results of your online psychological assessment and treatment recommendations (if symptoms were identified).[at baseline and immediately post intervention (14 weeks on), + 3 months after cessation of the intervention]

Secondary Outcome Measures

Name	Time	Method
il[Nil]