Group Cognitive Behavioral Therapy for IBD Patients

Inflammatory Bowel Diseases Clinical Trial

Official title:

The Impact of Group Cognitive Behavioral Psychotherapy on Disease Severity and Psychosocial Functioning of Inflammatory Bowel Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667586
• Other study ID #: 326/15.05.2018
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2022
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Group cognitive behavioral therapy
Group sessions based on the principles of Cognitive Behavioral Therapy and adjusted for chronic disease patients

Locations

Country	Name	City	State
Greece	Department of Gastroenterology	Patras

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Survey 36 Short Form (SF36)	The SF36 is a self-report, generic quality of life instrument, which includes eight multi-item scales (36 items) that evaluate the extent to which an individual's health limits his or her physical, emotional, and social well-being. The SF-36 covers eight domains of HRQOL, namely physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores on each subscale range from 0 to 100, with higher scores indicating a better quality of life. Sub-scales scores are calculated according to an algorithm described in the SF36 manual.	18 months
Primary	Hospital Anxiety and Depression Scale (HADS)	This is a widely used psychometric tool, comprised of 14 items, 7 items for anxiety and 7 items for depression. Each subscale is scored from 0-21. Higher scores indicate greater severity of depressive and anxious symptoms	18 months
Primary	Female Sexual Functioning Index (FSFI)	The FSFI is a 19-item questionnaire which measures 6 domains, namely sexual desire, arousal (both subjective and physiologic), lubrication, orgasm, satisfaction and pain. The 6 domain scores are summed to produce a full-scale score. For all FSFI domains, higher values indicate a better level of functioning	18 months
Primary	International Index of Erectile Function(IIEF)	This is a 15-item, validated questionnaire which has proven extremely useful in the clinical assessment of erectile dysfunction and has been widely used in clinical trials to evaluate treatment outcomes. Each question can be awarded a score between 0 and 5 and the questionnaire as a whole addresses the main four domains of male sexual functioning (erectile functioning, orgasmic functioning, sexual desire and intercourse satisfaction) along with a fifth component which encompasses the concept of overall sexual satisfaction	18 months
Secondary	Crohn's disease activity index	This is an index measuring the severity of Crohn's Disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease, and values above 450 are seen with extremely severe disease.	6 months
Secondary	Truelove and Witts' severity index	This is an index which classifies adult patients with ulcerative colitis into 3 categories (mild, moderate, severe) based on clinical signs and laboratory values.	6 months
Secondary	Feacal calprotectin	Faecal calprotectin is a biochemical measurement of the protein calprotectin in the stool. Elevated faecal calprotectin indicates the migration of neutrophils to the intestinal mucosa, which occurs during intestinal inflammation, including inflammation caused by inflammatory bowel disease.	6 months
Secondary	Serum cytokines levels	Cytokines are chemical substances involved in inflammatory processes. Their levels are altered in chronic inflammation such as in ulcerative colitis and Crohn's Disease	6 months