Internet-based Cognitive Behavioral Therapy for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Montefiore Medical Center

Disqualifiers: Severe psychological distress, suicidality, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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}

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

Trial 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 (Behavioral Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Montefiore Hutchinson Campus Bronx, NY

Who Is Running the Clinical Trial?

Montefiore Medical Center Lead Sponsor

National Center for Advancing Translational Sciences (NCATS) Collaborator

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] Internet-based cognitive behavior therapy (iCBT) can be effective in mental and somatic health care. Research on the feasibility of internet interventions in clinical practice is, however, still scarce. Studies with a focus on the patient regarding usability of interventions and digital health literacy skills are especially lacking.

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

Does Computerized Cognitive Behavioral Therapy Help People with Inflammatory Bowel Disease? A Randomized Controlled Trial. [2018] Cognitive behavioral therapy may be useful for improving health-related quality of life (HRQOL) of at least some patients with inflammatory bowel disease (IBD), especially those with psychiatric comorbidities. However, cognitive behavioral therapy can be difficult to access. These difficulties can be overcome by computerized cognitive behavioral therapy (CCBT). This is a randomized controlled trial of a self-administered CCBT intervention for patients with IBD focused on improving HRQOL. It is hypothesized that CCBT completers will have an improved HRQOL relative to people not allocated to CCBT.

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

Internet-Based Cognitive Behavioral Therapy Among Psychologists in a Medical Setting: A Survey on Implementation. [2020] Internet-based cognitive behavioral therapy (iCBT) is an effective treatment for patients with a chronic somatic illness to improve self-management skills and to learn to adjust to their chronic disease and its impact on daily life. However, the implementation of iCBT in clinical practice is challenging.

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] Internet-based cognitive behavioral therapy (ICBT) is a form of guided self-help that has been found to be effective for addressing several problems. The target for this type of therapy is usually restricted to one specific disorder. Tailoring the treatment widens the scope of ICBT in that it can address comorbid conditions directly.

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] Internet-based cognitive behavioral therapy (ICBT) is a relatively new therapy with unknown effectiveness in patients with cancer. In addition, therapist-guided and self-guided ICBT patient-specific outcomes for cancer patients remain to be explored.

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] Internet-delivered cognitive behavioural therapy (ICBT) is a promising approach for increasing access to evidence-based treatments.

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

Exploring Patient Perspectives on a 12-Week Online, Stress Reduction Intervention in Inflammatory Bowel Disease. [2023] Online stress reduction interventions may be useful adjuncts to standard medical therapies for inflammatory bowel disease (IBD). As part of the evaluation of a 12-week randomized control trial (RCT) of an online multicomponent stress reduction program, our aim for the current study was to use qualitative methods to more deeply explore the patient experience with the online programming.