Group Cognitive Behavioral Therapy for IBD Patients
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Inflammatory bowel disease (IBD) patients commonly suffer from disturbed psychosocial
      functioning and poor quality of life compared to other chronic disease patients. Clinicians
      are becoming growingly aware that addressing patients' psychological difficulties may improve
      disease management, however, there is not adequate evidence regarding the effect of
      psychotherapeutic interventions on psychosocial functioning and disease-related clinical and
      laboratory parameters. The aim of the present study is the evaluation of the effects of a
      targeted, cognitive behavioral psychotherapeutic intervention on symptom severity, levels of
      psychological distress and quality of life and inflammation and disease activity indices in
      IBD patients. An additional aim is the detection of psychological and biomedical parameters
      which may be associated with these effects.
    

Detailed 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 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.
    

Intervention name(s): Group cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): Group sessions based on the principles of Cognitive Behavioral Therapy and adjusted for chronic disease patients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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