Anxiety, Crohn's Disease (CD), Depression, Inflammatory Bowel Diseases (IBD), Ulcerative Colitis (UC)
Conditions
Brief summary
This study is being done to better understand the complex relationship between mental health and Inflammatory Bowel Disease (IBD), with a particular focus on symptoms of depression and anxiety. While depression and anxiety have traditionally been viewed as reactions to the burden of living with IBD, new research suggests that the biological factors involved in IBD may also contribute directly to these mental health challenges. This study aims to evaluate whether a virtual, group-based psychological treatment is both acceptable and feasible for patients with IBD who experience significant depression and/or anxiety. Researchers will also evaluate participants' depression, generalized anxiety, and associated psychosocial factors (poor sleep quality, GI-specific anxiety, fatigue) before, during, and after treatment. Finally, researchers will evaluate disease severity as it relates to mental health status by comparing it to symptoms, biochemical disease and tryptophan metabolites from blood and stool samples. People who agree to join the study will be asked to attend three in-person visits and 10 virtual group psychotherapy sessions over 11 weeks. Participants will be asked to complete questionnaires, give stool and blood samples, and the research team will collect information about participations from medical records.
Interventions
BEHAVIORALGroup Psychotherapy Intervention
Participants will engage in a course of ten, 120-minute sessions of group psychotherapy. The intervention will be guided by the Mind Over Mood treatment manual. Mind Over Mood is a manual that is published and commonly used to treat depression and anxiety as guided by a therapist and for self-help. For this study, the manual will be adapted for patients with IBD. Session content will include interventions such as psychoeducation on the brain-gut connection and the CBT model, behavioral activation and activity scheduling, cognitive monitoring and restructuring, development of behavioral experiments to test underlying assumptions, building acceptance and gratitude, and maintenance of gains and relapse prevention.
Sponsors
University of Chicago
GI Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18+ years of age * Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) * English-speaking * Patients with score ≥10 on General Anxiety Disorder-7 (GAD-7) questionnaire (considered moderate or higher anxiety symptoms) or ≥10 on the Patient Health Questionnaire-9 (PHQ-9) (considered moderate or higher depressive symptoms) within 3 months * Able to provide written consent
Exclusion criteria
* Unwilling and/or unable to participate * Non-English speakers * Unable to understand the instructions or to consent to participation in the study, including patients with a diagnosed cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine acceptability of a 10-session, group-based, virtual treatment guided by the Mind over Mood treatment manual in patients with IBD with clinically significant depression and/or anxiety | End of intervention at week 10 | Acceptability will be assessed using the Client Satisfaction Questionnaire-4 (CSQ-4), which is used to measure overall satisfaction and client self-efficacy in healthcare, mental health, and social programs. Scores range from 4-16, with higher scores indicating higher satisfaction with the treatment. CSQ-4 scores are commonly classified as "low satisfaction/dissatisfaction" (4-8), "moderate/neutral satisfaction" (9-12), and "high satisfaction" (13-16). |
| Determine feasibility of a 10-session, group-based, virtual treatment guided by the Mind over Mood treatment manual in patients with IBD with clinically significant depression and/or anxiety | End of treatment at 10 weeks | Feasibility will be assessed by analyzing recruitment and retention (i.e., number of patients who are referred that enroll in the study and complete treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depression | Before, during, and after treatment (weeks 0, 5, and 10). | Measured via Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report tool used to screen, diagnose, and measure the severity of depression in clinical settings. It scores depressive symptoms experienced over the past two weeks on a scale from 0 to 27, with higher scores indicating more severe symptoms. Scores are commonly classified as "minimal or no depression" (0-4), "mild depression" (5-9), "moderate depression" (10-14), "moderately severe depression" (15-19), and "severe depression" (20-27). |
| Change in anxiety | Before, during, and after treatment (weeks 0, 5, and 10). | Measured via Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report tool used to screen for anxiety and measure its severity over the past two weeks. Scores range from 0-21, with higher numbers indicating more severe symptoms. GAD-7 scores are commonly classified as "minimal anxiety" (0-4), "mild anxiety" (5-9), "moderate anxiety" (10-14), and "severe anxiety" (15-21). |
| Change in fatigue | Before, during, and after treatment (weeks 0, 5, and 10). | Measured via Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), 13-item tool that measures tiredness and how it affects daily life over the past 7 days. Scores range from 0-52, with higher numbers indicating less fatigue. FACIT-Fatigue scores are commonly classified as "severe fatigue" (0-21), "moderate fatigue" (22-30), "mild fatigue" (31-40), and "little to no fatigue" (40-52). |
| Change in sleep quality | Before, during, and after treatment (weeks 0, 5, and 10). | Measured via Pittsburgh Sleep Quality Index (PSQI), 19-item self-report questionnaire that evaluates subjective sleep quality and disturbances over a one-month time period. Scores range from 0-21, with higher numbers indicating worse sleep quality. PSQI scores are commonly classified as "good sleep quality" (0-5) and "poor sleep quality" (6-21). |
| Change in gastrointestinal symptom-specific anxiety (GSA) | Before, during, and after treatment (weeks 0, 5, and 10). | Measured via Visceral Sensitivity Index (VSI), a 15-item self-report questionnaire that evaluates GSA, including fear, hypervigilance, and avoidance of belly sensations. Scores range from 0-75, with higher numbers indicating worse GSA. |
| Change in clinical IBD outcomes (CD) | Before, during, and after treatment (weeks 0, 5, and 10). | Measured for patients with CD via change in scores on the Harvey Bradshaw Index (HBI), a clinical tool used to measure the severity of CD based on five patient symptoms from the previous day. Scores range from 0-16 and up, with higher numbers indicating more severe disease activity. HBI scores are commonly classified as "clinical remission" (0-4), "mild disease activity" (5-7), "moderate disease activity" (8-16), and "severe disease activity" (16 or more). |
| Change in clinical IBD outcomes (UC) | Before, during, and after treatment (weeks 0, 5, and 10). | Measured for patients with UC via change in scores on the Simple Clinical Colitis Activity Index (SCCAI), a clinical tool used to measure the severity of UC. Scores range from 0-5 and up, with higher numbers indicating more severe disease activity. UC scores are commonly classified as "clinical remission" (0-2), "mild disease activity" (3-4), and "active flare or relapse" (5 or more). |
| Change in biomedical IBD outcomes | Before, during, and after treatment (weeks 0, 5, and 10). | Change in biochemical inflammation measured by fecal calprotectin and c-reactive protein levels. |
| Change in targeted metabolites including compounds from tryptophan metabolism | Before, during, and after treatment (weeks 0, 5, and 10). | Change in untargeted metabolite levels |
Countries
United States
Contacts
CONTACTLead Study Coordinator
PRINCIPAL_INVESTIGATORAlyse Bedell, PhD, CST
University of Chicago
Outcome results
None listed