Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
130

Summary

Conditions
Inflammatory Bowel Diseases
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study design will be randomized prospective with a control group. More specifically, all patients will be randomly assigned either to the psychotherapy or the control group. Randomization will be 1:1 and will be performed through the method of sealed envelopes. A group of participants will receive weekly group cognitive behavioral therapy sessions, while another group will receive care as usual with regular weekly brief follow-ups by the gastroenterologists and the nurse of the research team. In total, the psychotherapeutic intervention will last for 6 months with participants attending weekly sessions for the first 3 months and monthly follow-up sessions for the next 3 months. All patients will be re-evaluated at 6 months (treatment completion), 12 months and 18 months after study initiation.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

Background Inflammatory bowel disease patients report increased levels of anxiety and depressive symptoms which are associated with poorer health-related quality of life (QoL). In addition, they commonly experience disturbed self- and body-image thus being vulnerable to interpersonal difficulties an...

Background Inflammatory bowel disease patients report increased levels of anxiety and depressive symptoms which are associated with poorer health-related quality of life (QoL). In addition, they commonly experience disturbed self- and body-image thus being vulnerable to interpersonal difficulties and sexual dysfunction. There are several studies reporting that the presence of co-morbid depression is more strongly associated with increased financial cost and hospitalization rates, worse treatment compliance and major QoL deficits compared to disease activity. For this reason, the current ECCO-EFCCA patient guidelines strongly recommend regular psychiatric evaluation as a necessary part of patients' standard follow-up and put particular emphasis on treating anxiety and depressive symptoms with the use of appropriate pharmacological or psychosocial interventions. However, relevant literature is relatively sparse, lacking wide-scale randomized trials focusing on the efficacy of antidepressants and psychotherapy not only on alleviating patients' psychological distress but also on improving IBD clinical and laboratory severity indices. More specifically, a recent systematic review identified only one randomized clinical trial on the effect of antidepressants in IBD patients. In a similar vein, there is a limited number of randomized clinical trials focusing on the effect of brief psychotherapeutic interventions on patients' psychological burden, QoL and disease progression. The importance of different immunoregulatory pathways mediated by several immunological cells subtypes and cytokines in the regulation of IBD has been demonstrated the last years. Cytokines have been directly implicated in the pathogenesis of IBD in genetic and immunological studies, and they establish a crucial role in controlling intestinal inflammation and the associated clinical symptoms of IBD. Despite the fundamental role of cytokines in controlling mucosal inflammation in IBD, to our knowledge, inflammation indices have never been evaluated as study end-points in investigations focusing on the role of psychotherapy on patients' QoL. Research hypotheses Our primary research hypothesis is that brief psychotherapeutic intervention will reduce IBD patients' gastrointestinal symptoms and psychological distress and improve their sexual functioning and QoL. A secondary hypothesis is that the observed improvement in psychosocial functioning will be accompanied by alterations in inflammation and disease activity indices. Research aim In this context, the aim of the current prospective randomized controlled study will be the measurement of the effects of brief group cognitive behavioral psychotherapy on gastrointestinal symptom severity, psychological distress, sexual functioning, QoL and inflammation and disease activity indices in IBD patients. An additional aim will be the detection of psychological and biomedical parameters which are associated with these effects.

Tracking Information

NCT #
NCT03667586
Collaborators
Not Provided
Investigators
Principal Investigator: Christos Triantos, PhD University of Patras, Medical School