Internet-based Cognitive Behavioral Therapy for Inflammatory Bowel Disease

Overseen By Sheila Benitez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Severe psychological distress, suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how internet-based cognitive behavioral therapy (iCBT) can assist individuals with inflammatory bowel disease (IBD) who also experience anxiety, depression, or stress. The focus is on Black and Latino individuals with Crohn's disease or ulcerative colitis, as these groups are often underrepresented in research. Participants should be comfortable using digital technology and have high levels of psychological distress, but not severe mental health issues. The goal is to adapt a therapy program into an app and assess its impact on mental health and IBD symptoms. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance mental health care for underrepresented communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on internet-based therapy for mental health support in IBD patients.

What prior data suggests that internet-based cognitive behavioral therapy is safe for people with inflammatory bowel disease?

Studies have shown that cognitive behavioral therapy (CBT), including its online version, is generally safe and well-tolerated. For individuals with inflammatory bowel disease (IBD), CBT has effectively improved mental health and quality of life.

Research indicates that internet-based CBT can manage anxiety and depression without significant side effects. This finding is important because it demonstrates that using a digital platform for therapy is not riskier than traditional methods.

While most people do not experience negative effects, some might find the therapy challenging or uncomfortable. However, serious negative reactions are rare with CBT. Overall, internet-based CBT is considered a safe option for those seeking to improve their mental health while managing IBD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Internet-based Cognitive Behavioral Therapy (CBT) is unique because it offers a novel approach for managing Inflammatory Bowel Disease (IBD) by focusing on mental well-being alongside physical symptoms. Unlike standard treatments that typically involve medications like anti-inflammatories or immunosuppressants, this therapy leverages the mind-body connection to potentially reduce stress-induced flare-ups. Researchers are excited about this treatment because it’s accessible online, making it convenient for patients to integrate into their daily lives, and it empowers them with tools to better handle the psychological aspects of living with IBD.

What evidence suggests that internet-based cognitive behavioral therapy is effective for inflammatory bowel disease?

Studies have shown that online cognitive behavioral therapy (iCBT) can enhance mental health and quality of life for individuals with inflammatory bowel disease (IBD). Research indicates that CBT, delivered via telehealth, reduces IBD-related issues by addressing stress and anxiety, which can exacerbate the disease. A review of studies highlighted CBT as the most effective therapy for managing IBD. This trial will assess the effectiveness of iCBT in managing both the mental health challenges and physical symptoms linked to IBD. ^{1 3 6 7 8}

Who Is on the Research Team?

Ruby Greywoode, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for Black or Hispanic/Latino individuals with Crohn's disease or ulcerative colitis who are experiencing psychological distress but not severe mental health issues like active suicidality. Participants must be able to consent in English and have basic computer skills.

Inclusion Criteria

Self-identify as Black or Hispanic/Latino

Ability to provide informed consent in English

Elevated psychological distress

Exclusion Criteria

Active suicidality, past suicide attempt, or psychiatric hospitalization

Severe psychological distress

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive internet-based cognitive behavioral therapy (iCBT) to address psychological distress related to IBD

8 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for changes in psychological and disease-related factors after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Internet-based Cognitive Behavioral Therapy

Trial Overview The study tests internet-based Cognitive Behavioral Therapy (iCBT) tailored for racial and ethnic minority groups with IBD, aiming to improve mental health and quality of life by considering digital access, stigma, and lived experiences.

How Is the Trial Designed?

Group I: Internet-based Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

A randomized controlled trial involving 199 patients with inflammatory bowel disease (IBD) showed that those who completed a self-administered computerized cognitive behavioral therapy (CCBT) program had significant improvements in health-related quality of life (HRQOL) and mental health scores at 12 weeks compared to those receiving usual treatment.

However, these improvements were not sustained at 6 months, and factors such as baseline depression and lower initial HRQOL scores were linked to higher dropout rates, suggesting that CCBT may not be effective for all IBD patients, particularly those with comorbid depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Computerized Cognitive Behavioral Therapy Help People with Inflammatory Bowel Disease? A Randomized Controlled Trial. McCombie, A., Gearry, R., Andrews, J., et al.[2018]

The BIP OCD Junior program, an internet-delivered cognitive behavioral therapy (ICBT) for children aged 7-11 with OCD, showed significant improvement in symptoms after 12 weeks, with a large effect size (Cohen's d = 1.86).

Both children and parents found the treatment credible and were highly satisfied, suggesting that ICBT could be a feasible option for young children with OCD, although further randomized controlled trials are needed to confirm its efficacy compared to traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered cognitive behavioural therapy for young children with obsessive-compulsive disorder: development and initial evaluation of the BIP OCD Junior programme. Aspvall, K., Andrén, P., Lenhard, F., et al.[2022]

A study involving 32 patients assessed the usability of an internet-based cognitive behavior therapy program for chronic pain, revealing that most participants could complete tasks independently, but struggled with logging in and navigating the program.

Usability was found to be negatively correlated with age and positively correlated with digital health literacy skills, suggesting that tailored support may be necessary to help different age groups and skill levels effectively use the iCBT program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Age, Education, and Digital Health Literacy in the Usability of Internet-Based Cognitive Behavioral Therapy for Chronic Pain: Mixed Methods Study. van der Vaart, R., van Driel, D., Pronk, K., et al.[2020]

Internet-based cognitive behavioral therapy (ICBT) significantly improves psychological distress, anxiety, and depression in cancer patients, with effects lasting even after the intervention, based on a meta-analysis of 3,249 participants from 20 studies.

Therapist-guided ICBT is more effective than self-guided ICBT for managing psychological distress and enhancing quality of life, making it the preferred option for cancer patients seeking psychological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Internet-Based Cognitive Behavioral Therapy for Patients With Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Yu, S., Liu, Y., Cao, M., et al.[2023]

Only 15.9% of psychologists in a medical setting currently use internet-based cognitive behavioral therapy (iCBT), despite a high intention to use it in the future (21.5% expected to start within a year).

The study identified that performance expectancy, effort expectancy, and social influence significantly affect the intention to use iCBT among nonusers, indicating that addressing these factors could improve actual implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive Behavioral Therapy Among Psychologists in a Medical Setting: A Survey on Implementation. IJzerman, RVH., van der Vaart, R., Evers, AWM.[2020]

A 12-week randomized control trial involving an online stress reduction program showed that participants with inflammatory bowel disease (IBD) experienced a perceived reduction in symptom burden and improved management of stress related to their condition.

Qualitative interviews with 56 participants revealed that IBD causes significant stress and uncertainty, but the online program helped foster a more positive mindset, suggesting that enhancing program content and community connections could further improve its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Patient Perspectives on a 12-Week Online, Stress Reduction Intervention in Inflammatory Bowel Disease. Watt, M., Peerani, F., Madsen, K., et al.[2023]

In a study involving 27 participants undergoing tailored internet-based cognitive behavioral therapy (ICBT) for anxiety disorders, the strength of the working alliance measured at week 3 was found to significantly predict treatment outcomes, indicating its importance in ICBT.

Pre-treatment working alliance did not show a significant correlation with treatment outcomes, suggesting that the therapeutic relationship may become more crucial as therapy progresses rather than at the start.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the working alliance on treatment outcome in tailored internet-based cognitive behavioural therapy for anxiety disorders: randomized controlled pilot trial. Bergman Nordgren, L., Carlbring, P., Linna, E., et al.[2022]

Citations

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Internet-based Cognitive Behavioral Therapy in ... Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5288424/

Cognitive-Behavioural Therapy for Inflammatory Bowel ... The present two-arm pragmatic randomised controlled trial aimed to establish the impact of CBT on disease course after 24 months of observation.

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Inflammatory Bowel Diseases-Specific Cognitive ... Inflammatory Bowel Diseases-Specific Cognitive Behavioral Therapy Delivered Through Telehealth Reduces Disability: Addressing Disability ...

4. withpower.com withpower.com/trial/phase-psychological-distress-6-2022-ab029

Internet-based Cognitive Behavioral Therapy for ... Cognitive behavioral therapy (CBT) is the most studied psychotherapeutic approach in IBD and the one that suggests improvements in mental health and quality of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8672154/

The physiological and psychological effects of cognitive ... A systematic review indicated that cognitive-behavioral therapy (CBT) was the most effective psychotherapy for IBD [36]. It is a psychological ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5425996/

Cognitive behavioural therapy for the management of ... Does computerized cognitive behavioral therapy help people with inflammatory bowel disease? A randomized controlled trial. Inflamm Bowel Dis.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0166432823003716

Effects of cognitive behavioral therapy on mental health ... We aim to assess the roles of cognitive behavioral therapy (CBT) in improving quality of life (QoL) and mental health in inflammatory bowel disease (IBD) ...

8. jmir.org jmir.org/2022/6/e35260/

Internet-Delivered Cognitive Behavioral Therapy in ... This review demonstrates that internet-delivered cognitive behavioral therapy could be a cost-effective intervention for improving symptoms and the quality of ...