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Group Cognitive Behavioral Therapy for IBD Patients

31 de mayo de 2022 actualizado por: Christos Triantos, University Hospital of Patras

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

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

79

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Patras, Grecia, 26504
        • Department of Gastroenterology

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group Cognitive Behavioral Therapy
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.
Group sessions based on the principles of Cognitive Behavioral Therapy and adjusted for chronic disease patients
Comparador de placebos: Standard care
Regular brief follow-ups by the gastroenterologists and the nurse of the research team
Group sessions based on the principles of Cognitive Behavioral Therapy and adjusted for chronic disease patients

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Health Survey 36 Short Form (SF36)
Periodo de tiempo: 18 months
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)
Periodo de tiempo: 18 months
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)
Periodo de tiempo: 18 months
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)
Periodo de tiempo: 18 months
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Crohn's disease activity index
Periodo de tiempo: 6 months
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
Truelove and Witts' severity index
Periodo de tiempo: 6 months
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
Feacal calprotectin
Periodo de tiempo: 6 months
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
Serum cytokines levels
Periodo de tiempo: 6 months
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Christos Triantos, PhD, University of Patras, Medical School

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de febrero de 2019

Finalización primaria (Actual)

31 de mayo de 2022

Finalización del estudio (Actual)

31 de mayo de 2022

Fechas de registro del estudio

Enviado por primera vez

9 de septiembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2018

Publicado por primera vez (Actual)

12 de septiembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de junio de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

31 de mayo de 2022

Última verificación

1 de mayo de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 326/15.05.2018

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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