Group Cognitive Behavioral Therapy for IBD Patients

NCT03667586 | Completed

• 1 other identifier: 326/15.05.2018
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Crohn's disease activity index

  6 months

• Truelove and Witts' severity index

  6 months

• Feacal calprotectin

  6 months

• Serum cytokines levels

  6 months

Study Arms (2)

Group Cognitive Behavioral Therapy

EXPERIMENTAL

Cognitive behavioral psychotherapy sessions will be conducted at an appropriately accommodated office of the Psychiatry Department in groups of 6-10 patients and will be coordinated by a qualified psychologist of the research team. Each session will be of 90 minutes duration. The initial two sessions will be psycho-educational and the remaining sessions will be based on the principles of Cognitive Behavioral Therapy (CBT). 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.

Behavioral: Group cognitive behavioral therapy

Standard care

PLACEBO COMPARATOR

Regular brief follow-ups by the gastroenterologists and the nurse of the research team

Behavioral: Group cognitive behavioral therapy

Interventions

Group cognitive behavioral therapy BEHAVIORAL

Group sessions based on the principles of Cognitive Behavioral Therapy and adjusted for chronic disease patients

Group Cognitive Behavioral Therapy; Standard care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)"

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

Department of Gastroenterology

Pátrai, 26504, Greece

Location

Related Publications (8)

• 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.

  PMID: 29181373 BACKGROUND

• 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.

  PMID: 27645518 BACKGROUND

• 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.

  PMID: 28267046 BACKGROUND

• 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.

  PMID: 26303912 BACKGROUND

• 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.

  PMID: 26360545 BACKGROUND

• 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.

  PMID: 27432441 BACKGROUND

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

• Kalogeropoulou M, Karaivazoglou K, Konstantopoulou G, Vinni E, Sotiropoulos C, Tourkochristou E, Aggeletopoulou I, Lourida T, Labropoulou E, Diamantopoulou G, Mouzaki A, Assimakopoulos K, Gourzis P, Thomopoulos K, Theocharis G, Triantos C. The Impact of Group Cognitive Behavioral Psychotherapy on Disease Severity and Psychosocial Functioning in Patients With Inflammatory Bowel Disease: A Randomized Controlled Study. J Crohns Colitis. 2025 Mar 5;19(3):jjae144. doi: 10.1093/ecco-jcc/jjae144.

  PMID: 39316575 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Christos Triantos, PhD

  University of Patras, Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Internal Medicine and Gastroenterology

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 12, 2018
• Study Start: February 21, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)