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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Internet-based Cognitive Behavioral Therapy for Inflammatory Bowel Disease?

Research suggests that Internet-based Cognitive Behavioral Therapy (iCBT) can help people with chronic illnesses, like inflammatory bowel disease (IBD), by improving their ability to manage the disease and its impact on daily life. It has been shown to improve health-related quality of life for some IBD patients, especially those with additional mental health issues. ^{1 2 3 4 5}

Is Internet-based Cognitive Behavioral Therapy safe for humans?

The research does not provide specific safety data for Internet-based Cognitive Behavioral Therapy, but it is generally considered a safe approach as it is a form of guided self-help therapy. ^{1 3 4 5 6}

How is Internet-based Cognitive Behavioral Therapy different from other treatments for inflammatory bowel disease?

Internet-based Cognitive Behavioral Therapy (iCBT) is unique because it is an online treatment that helps patients with inflammatory bowel disease (IBD) improve their quality of life by teaching them self-management skills and how to adjust to their condition. Unlike traditional therapies, iCBT is accessible from home, making it easier for patients to receive support without needing to visit a clinic. ^{1 2 3 5 7}

What is the purpose of this trial?

While people of color are an increasing segment of the inflammatory bowel disease (IBD) population, they are currently underrepresented in research, including studies of psychological distress. Appreciation for psychological distress (anxiety, depression, perceived stress) as a driver of IBD activity has led to increased efforts to integrate psychological interventions into IBD medical care. Cognitive behavioral therapy (CBT) is the most studied psychotherapeutic approach in IBD and the one that suggests improvements in mental health and quality of life in those with elevated psychological distress. There are unanswered questions in the use of CBT in IBD: how to leverage digital technology to deliver CBT through internet-based cognitive behavioral therapy (iCBT); how do we consider the social context of individuals from racial and ethnic minority groups who may experience distinct social and structural barriers to acceptance and use of psychological interventions? Thus, this study will qualitatively analyze how factors, such as digital access, mental health stigma, and lived experience with IBD and as racial or ethnic minority influence attitudes toward mental health and iCBT in a cohort of Black and Latino IBD patients with elevated psychological distress. Results will lead to adaptation of a CBT program into an iCBT app to be tested for acceptance/use and to explore effects on psychological and disease-related factors.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. Canada 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Does Computerized Cognitive Behavioral Therapy Help People with Inflammatory Bowel Disease? A Randomized Controlled Trial. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive Behavioral Therapy Among Psychologists in a Medical Setting: A Survey on Implementation. [2020]

4. Canada 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. [2022]

5. United States 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. [2023]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Exploring Patient Perspectives on a 12-Week Online, Stress Reduction Intervention in Inflammatory Bowel Disease. [2023]