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The study will examine the efficacy of an internet-based cognitive behavioural therapy (iCBT) for Inflammatory Bowel Disease (IBD) intervention to reduce stress, anxiety, and depression in individuals with IBD and comorbid clinically elevated t anxiety and/or depressive symptoms. The investigators will conduct a two-arm RCT comparing participants receiving the iCBT intervention (intervention group) and those receiving Treatment As Usual (TAU).
Inflammatory bowel disease (IBD) affects over a quarter of a million Canadians and this rate is expected to increase to 403,000 by year 2030 (Kaplan, Bernstein, Coward, Bitton, Murthy, Nguyen, Lee, Cooke-Lauder, Benchimol, 2019). The disease has a high burden for patients, with unpredictable, painful symptoms often requiring costly medications and surgery to facilitate disease remission. It is well established that individuals with IBD have significantly higher rates of anxiety and depression compared to the general population. (Bernstein, 2017; Graff, Walker, & Bernstein, 2009; Mikocka-Walus, Knowles, Keefer, Graff, 2016; Walker, Ediger, Graff, Greenfeld, Clara, Lix, Rawsthorne, Miller, Rogala, McPhail, & Bernstein, 2008).
There is growing research on psychological treatment for individuals with IBD, providing some evidence that Cognitive Behavioural Therapy (CBT) reduces psychological distress in this population (Knowles, Monshat, & Castle, 2013). Traditional CBT delivery methods involve in-person treatment, with multiple sessions over time, either one-on-one or in small groups. Development of alternate modes of effective treatment delivery is vital to enhance access and facilitate availability, particularly given limited mental health service availability. Internet-Based Cognitive Behaviour Therapy (iCBT) may be an effective alternative treatment for persons with IBD and related stress, anxiety and/or depression (McCombie, 2016) as it may mitigate the aforementioned challenges. Potential benefits of iCBT include enhanced cost effectiveness, little to no wait time to begin treatment, and increased accessibility.
Our research group developed and pilot-tested an internet-based cognitive behavioural therapy (iCBT) intervention targeting stress, anxiety and/or depression in adults with IBD. The intervention is housed on the Minddistrict online platform, the same platform used in our pilot study (HREB Ethics HS22087 (H2018:333) (Minddistrict, 2018, June, 1).The program was designed to be completed over 12 weeks. The study coordinator will be tracking participants' progress through the intervention by reviewing completion of questionnaires and modules.
The intervention includes 9 core modules and 3 optional modules. CORE Modules: 1. About the program, 2. IBD and Stress, 3. Relaxation Strategies, 4, Commitment to Living Life Fully, 5. The Brain-Gut Connection, 6. Understanding Anxiety, 7. Overcoming Avoidance, 8. Depression, 9. Behavioural Activation Optional Modules: 11. IBD and the Workplace, 12. Coping with Pain through Mindfulness, 13. Fatigue and Sleep
The next stage in extending this research is to conduct a randomized control trial (RCT) to determine the efficacy of this internet-based intervention, utilizing a control condition and ensuring adequate sample size powered to detect differences between the intervention group and Treatment as Usual (TAU).
Participants will be adults with confirmed inflammatory bowel disease, recruited from local enrollees of the IMAGINE study described earlier (IMAGINE, 2020, July, 2). They will be contacted by email to invite for participation in this study.
Participants will be randomized using a computer-generated randomization schedule which allows for allocation concealment with a ratio of 1.2 (iCBT) : 1.0 (TAU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | This group will receive the iCBT for IBD online intervention once enrolled. |
|
| Treatment as Usual | No Intervention | This group will be offered the iCBT for IBD intervention 24 weeks after enrollment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy | Behavioral | Internet-Based CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| PSS-4 | Change in Perceived Stress Scale 4 (PSS-4) scale measuring psychological stress (4 items); likert scale 0 (never) to 4 (very often); higher scores indicate higher levels of perceived stress | Baseline, 6, 12 and 24 weeks |
| HADS | Change in Hospital Anxiety and Depression Scale (HADS) scale measuring anxiety and depression (14 items); likert scale 0 (not at all) to 3 (most of the time); higher scores(summed) indicate presence of anxiety or depression | Baseline, 6, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-29 | Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29) scale measuring health-related quality of life (29 items); likert scale 1 to 5, varying anchor points; in symptom oriented domains higher scores represent worse symptomology and in function oriented domains higher scores represent better functioning | Baseline, 6, 12 and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Furer, PhD. | Contact | 204-237-2335 | pfurer@sbgh.mb.ca | |
| Gia Ly, MSc. | Contact | 204-787-4799 | giave.ly@umanitoba.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Recruiting | Winnipeg | Manitoba | R3A 1R9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| WSAS | Change in the Work and Social Adjustment Scale (WSAS) scale measuring how inflammatory bowel disease impact daily functioning; likert scale 1(not at all) to 5 (very severely); higher scores indicate higher levels higher functional impairment | Baseline, 6, 12 and 24 weeks |
| IBDSI-SF | Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI) scale measuring symptoms of inflammatory bowel disease; likert scale with varying anchor points | Baseline, 6, 12 and 24 weeks |
| CGI | Change in Clinical Global Impression - Improvement scale (CGI-I) scale measuring confidence in ability to manage stress (2 items); likert scale with varying anchor points; higher scores indicate higher stress and lower confidence | Baseline, 6,12 and 24 weeks |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |