Clinical trial NCT03667586: Group Cognitive Behavioral Therapy for IBD Patients
Official title: The Impact of Group Cognitive Behavioral Psychotherapy on Disease Severity and Psychosocial Functioning of Inflammatory Bowel Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult outpatients suffering from Crohn's disease or ulcerative colitis according to the ECCO-EFCCA Patient Guidelines, in both statuses "currently experiencing a flare/relapse" or "not currently experiencing a flare/relapse (in remission)"

Exclusion Criteria:

* major psychopathology
* severe cognitive or neurological deficits
* cancer
* other severe chronic diseases or disabilities
* lack of fluency in the Greek language

Primary outcomes:
measure: Health Survey 36 Short Form (SF36)
timeFrame: 18 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 18 months
measure: Female Sexual Functioning Index (FSFI)
timeFrame: 18 months
measure: International Index of Erectile Function(IIEF)
timeFrame: 18 months
Secondary outcomes:
measure: Crohn's disease activity index
timeFrame: 6 months
measure: Truelove and Witts' severity index
timeFrame: 6 months
measure: Feacal calprotectin
timeFrame: 6 months
measure: Serum cytokines levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Department of Gastroenterology
Study officials:
affiliation: University of Patras, Medical School
name: Christos Triantos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Byrne G, Rosenfeld G, Leung Y, Qian H, Raudzus J, Nunez C, Bressler B. Prevalence of Anxiety and Depression in Patients with Inflammatory Bowel Disease. Can J Gastroenterol Hepatol. 2017;2017:6496727. doi: 10.1155/2017/6496727. Epub 2017 Oct 18.
citation: Limsrivilai J, Stidham RW, Govani SM, Waljee AK, Huang W, Higgins PD. Factors That Predict High Health Care Utilization and Costs for Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2017 Mar;15(3):385-392.e2. doi: 10.1016/j.cgh.2016.09.012. Epub 2016 Sep 17.
citation: Macer BJ, Prady SL, Mikocka-Walus A. Antidepressants in Inflammatory Bowel Disease: A Systematic Review. Inflamm Bowel Dis. 2017 Apr;23(4):534-550. doi: 10.1097/MIB.0000000000001059.
citation: Schoultz M, Atherton I, Watson A. Mindfulness-based cognitive therapy for inflammatory bowel disease patients: findings from an exploratory pilot randomised controlled trial. Trials. 2015 Aug 25;16:379. doi: 10.1186/s13063-015-0909-5.
citation: McCombie A, Gearry R, Andrews J, Mulder R, Mikocka-Walus A. Does Computerized Cognitive Behavioral Therapy Help People with Inflammatory Bowel Disease? A Randomized Controlled Trial. Inflamm Bowel Dis. 2016 Jan;22(1):171-81. doi: 10.1097/MIB.0000000000000567.
citation: Mikocka-Walus A, Bampton P, Hetzel D, Hughes P, Esterman A, Andrews JM. Cognitive-Behavioural Therapy for Inflammatory Bowel Disease: 24-Month Data from a Randomised Controlled Trial. Int J Behav Med. 2017 Feb;24(1):127-135. doi: 10.1007/s12529-016-9580-9.