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.

In adults with Inflammatory bowel disease and associated anxiety and depression, will participation in an online psychological treatment program, as opposed to receiving treatment as usual, reduce symptoms of anxiety and depression

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000820808

Enrollment

Registered

2012-08-06

Start date

2012-08-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients will be recruited from outpatient clinics at Royal Melbourne Hospital (3052) and St Vincent’s Hospital (3065). This research involves the development and evaluation of an online intervention designed to provide individually tailored interventions to treat Panic Disorder, Major Depression, Social Anxiety, and Generalised Anxiety associated with IBD. Research has shown that people with IBD have higher levels of Panic Disorder (PD) and Major Depression (MDE; Major Depressive Episode), Social Anxiety Disorder (SAD), and Generalised Anxiety Disorder (GAD) than people with other chronic health conditions. While research on the effectiveness of psychological interventions in IBD is encouraging to date only limited work has been done on the evaluation of these programs. The aims of the current research project are to: (1) Develop and validate an online psychological treatment program specifically designed to diagnose and treat PD GAD, SAD, and/or MDE symptoms associated with IBD, and (2) Make this specialized service available free of charge to all individuals with IBD throughout Australia and internationally. In this project a three stage development and evaluation of an online intervention for IBD: (1) Development stage where an IBDeTherapy website is developed, revised and tested; (2) Evaluation stage I where 40 IBD patients complete a 14 week intervention program online; and, (3) Evaluation stage II involves 240 individuals from an IBD outpatient hospital cohort (Intervention groups: 30 MDE, 30 PD, 30 SAD, 30 GAD; Treatment as usual control groups: 30 MDE, 30 PD, 30 SAD, 30 GAD) in a large trial of the program that incorporates changes based on the initial evaluation stage. The present project is innovative because provision of online programs for IBD sufferers has the potential to provide better psychological care to these people than previously available. In addition, the established effectiveness of online intervention programs with clinical populations suggests that an online intervention is likely to have a high uptake and thus reduce the pressure on the health system.

Interventions

The aims of the project are to: (1) Develop and validate an online psychological treatment program specifically designed to diagnose and treat Panic Disorder (PD) and/or Major Depressive Episode (MDE), Social Anxiety Disorder (SAD), Generalised Anxiety Disorder (GAD) associated with IBD; and, (2) Make this specialized service available free of charge to all individuals with IBD throughout Australia and internationally. The treatment program, a CBT based support program, address several key issues identified in the literature and in the IBD clinics, including; psychoeducation about IBD, nutrition and IBD, mindfulness and relaxation strategies, managing pain, dealing with worry and unhelpful thoughts, and identifying and establishing adaptive cognitive coping strategies. Participants, over 14 weeks (completing one module per week in their own time [max 2 hours/module]) complete the assessment and treatment modules they will also be asked to provide feedback and suggestions regarding the IBDclinic content in weekly questionnaires (mailed back at the end of the intervention).

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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.

Outcome results