Effects of Psychiatric Comorbidity in Immune-Mediated Inflammatory Disease: Protocol for a Prospective Study.

BACKGROUND: Immune-mediated inflammatory diseases (IMID), such as inflammatory bowel disease (IBD), multiple sclerosis (MS), and rheumatoid arthritis (RA), are highly prevalent in Canada and the United States and result in substantial personal and societal burden. The prevalence of psychiatric comorbidities, primarily depression and anxiety, in IMID exceeds those in the general population by two- to threefold, but remains underdiagnosed and undertreated. Furthermore, the effects of psychiatric comorbidity on IMID are not well understood.

OBJECTIVE: The objectives of this study were (1) to compare health-related quality of life and work ability in persons with IMID and psychiatric comorbidity with those of persons with IMID without psychiatric comorbidity and with those of persons with depression and anxiety disorders alone, and (2) to validate existing case identification tools for depression and anxiety in persons with IMID to facilitate improved identification of depression and anxiety by clinicians. To achieve these objectives, we designed a prospective 3-year longitudinal study. In this paper, we aim to describe the study rationale and design and the characteristics of study participants.

METHODS: Between November 2014 and July 2016, we recruited 982 individuals from multiple clinic and community sources; 18 were withdrawn due to protocol violations.

RESULTS: The final study sample included 247 participants with IBD, 255 with MS, 154 with RA, and 308 with depression or anxiety. The majority were white, with the proportion ranging from 85.4% (IBD [210/246]; MS [217/254]) to 74.5% (114/153, RA; P=.01). There was a female predominance in all groups, which was highest in the RA cohort (84.4%, 130/154) and least marked in the IBD cohort (62.7%, 155/247). Participants with depression or anxiety were more likely to be single (36.0%, 111/308) than participants in any other group (11.8% [30/255]-22.7% [56/247], P<.001).

CONCLUSIONS: This paper presents the rationale for this study, describes study procedures, and characterizes the cohort enrolled. Ultimately, the aim is improved care for individuals affected by IMID.