Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04700917
Other study ID # H2020:430
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2021
Est. completion date December 2024

Study information

Verified date May 2023
Source University of Manitoba
Contact Patricia Furer, PhD.
Phone 204-237-2335
Email pfurer@sbgh.mb.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 352
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants will need to be at least 18 years of age or older, be diagnosed by a physician with IBD (Crohn's disease or Ulcerative Colitis), have anxiety and/or depression scores > 8 on the Hospital Anxiety and Depression Scale (HADS-A or HADS-D), have access to a computer, and be literate in the English language. Participants may be on psychotropic medication but dosage should be stable for at least six weeks prior to study enrollment. Exclusion Criteria: - Individuals who have had, within the last six months, suicidal ideation or suicidal intent, self-harming behaviour, active substance use disorder, psychotic disorder, or an eating disorder will be excluded. Presence of these behaviours and disorders will be determined through the screening process described in the next section. Individuals who are currently receiving cognitive behavioral treatment for an anxiety or mood disorder, or have participated in such treatment in the previous three months, are not eligible for this study.

Study Design


Intervention

Behavioral:
Cognitive Behavioural Therapy
Internet-Based CBT

Locations

Country Name City State
Canada University of Manitoba Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A