Protocolized cognitive-behavioral group therapy for inflammatory bowel disease

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1 09. OR1099 M. A. DI?AZ SIBAJA :Maquetación 1 5/12/07 09:24 Página /2007/99/10/ REVISTA ESPAÑOLA DE ENFERMEDADES DIGESTIVAS Copyright 2007 ARÁN EDICIONES, S. L. REV ESP ENFERM DIG (Madrid) Vol. 99. N. 10, pp , 2007 Protocolized cognitive-behavioral group therapy for inflammatory bowel disease M. A. Díaz Sibaja, M. I. Comeche Moreno 1 and B. Mas Hesse 1 Clinical Psychology Area. District Team of Mental Health (ESMD). Algeciras. Cádiz, Spain. 1 Departament of Personality, Evaluation and Psychological Treatments of the UNED. Madrid, Spain RESUMEN Introducción: los pacientes con enfermedades inflamatorias intestinales presentan una mayor tasa de alteraciones psicopatológicas que la población normal, predominantemente ansiedad y depresión. Objetivo: el principal objetivo de este estudio fue diseñar, poner en práctica y validar un programa de tratamiento psicológico protocolizado, basado en el modelo de competencias y con una metodología psicoeducativa, en el que se incluyeron los siguientes módulos de intervención: información de la enfermedad, modelo de afrontamiento, solución de problemas, técnicas de relajación, entrenamiento en habilidades sociales, técnicas de distracción y técnicas de reestructuración cognitiva. Todas estás técnicas fueron adaptadas a la problemática característica de la enfermedad inflamatoria intestinal. Método: la muestra estuvo constituida por 57 pacientes diagnosticados de enfermedad inflamatoria intestinal de la Asociación de Enfermos de Crohn y Colitis Ulcerosa de España. La muestra se distribuyó aleatoriamente en dos grupos experimentales, 33 formaron parte del programa de tratamiento en grupo y 24 fueron asignados al grupo control en lista de espera. Las variables emocionales medidas fueron: ansiedad y depresión. Resultados: los resultados reflejaron una mejoría clínica y estadísticamente significativa en las variables de ansiedad (p < 0,001) y depresión (p < 0,001), al compararlo con el grupo control en lista de espera. Asimismo, esa mejoría se mantiene en los seguimientos realizados a los 3, 6 y 12 meses. Conclusión: el programa de tratamiento psicológico protocolizado y administrado en grupo resulta eficaz para disminuir la sintomatología emocional que puede presentarse como consecuencia del padecimiento de la enfermedad inflamatoria intestinal. Palabras clave: Enfermedad inflamatoria intestinal. Tratamiento cognitivo conductual. Tratamiento protocolizado. Programa de tratamiento multicomponente. Crohn y colitis ulcerosa. ABSTRACT Introduction: patients affected by inflammatory bowel disease have a high rate of psychiatric disorders such as depression and anxiety. Objective: the main goal of this study was to design, to put into practice, and to validate a protocolized psychological treatment program based on the coping model, and a psycho-educational methodology in which the following intervention modules were included illness information, coping model, problem solving techniques, relaxation, social skill training, distraction, and cognitive restructuring techniques. All these techniques were adapted to the characteristic features of inflammatory bowel disease. Method: the sample included 57 patients with inflammatory bowel disease from the Spanish Crohn's Disease and Ulcerative Colitis Association. The sample was randomly assigned to one of the two experimental groups 33 were assigned to the treatment group, and 24 were assigned to the waiting list control group. Results: the results reflected a significant clinical and statistical improvement in anxiety (p < 0.001) and depression (p < 0.001) variables when compared to the waiting list control group. Likewise, improvement was sustained at 3, 6, and 12 months during follow-up. Conclusion: the protocolized psychological treatment program, administered in group sessions, is effective in reducing emotional symptoms arising as a result of inflammatory bowel disease. Key words: Inflammatory bowel disease. Cognitive-behavioral therapy. Protocolized treatment. Multi-component psychological treatment program. Crohn s disease and ulcerative colitis. Díaz Sibaja MA, Comeche Moreno MI, Mas Hesse B. Protocolized cognitive-behavioral group therapy for inflammatory bowel disease. Rev Esp Enferm Dig 2007; 99: Received: Accepted: Correspondence: Miguel Ángel Díaz Sibaja. Equipo de Salud Mental de Distrito (ESMD). Pso. de la Conferencia, s/n Algeciras. Cádiz, Spain. diazsibaja@ono.com INTRODUCTION The relationship between inflammatory bowel disease and emotional dysfunction has been a subject of research in the last few years. Patients affected by inflammatory

2 09. OR1099 M. A. DI?AZ SIBAJA :Maquetación 1 5/12/07 09:24 Página M. A. DÍAZ SIBAJA ET AL. REV ESP ENFERM DIG (Madrid) bowel disease have a high rate of psychiatric disorders such as depression and anxiety (1-6). It has been verified that psychopathological symptoms vary and become worse depending on the course of the illness, which would suggest that psychiatric disorders are secondary to physical illness (3,7). It is possible that a relationship between psychopathology and inflammatory bowel disease may depend on the psychosocial repercussions given as a consequence of disease. Recent psycho-immunological studies have demonstrated that suffering from inflammatory bowel disease increases the potential for emotional dysfunction, while the latter in turn affects inflammatory bowel disease, often increasing symptom severity (8,9). Likewise, it is verified that patients most depressed or anxious are those who suffer from earlier, more frequent relapse after a period of symptom remission (7,10). These authors observed that depressed patients relapse after 97 days on average, while non-depressed subjects relapse after 362 days. The relationship between illness and psychosocial factors, the high comorbidity between inflammatory bowel disease and psychopathological dysfunction, together with the fact that many patients do not know what to do or how to face the problems generated by their disease, has led some researchers to develop and implement psychological intervention programs (11-18). The main target of these kinds of treatments is to teach patients to apply effective confrontation strategies that may help them solve associated psychological dysfunction, improve their quality of life, and confront disease demands in a more effective way. The current experimental study intends to demonstrate the effectiveness of a protocolized psychological treatment program to reduce the emotional symptoms that can emerge as a consequence of inflammatory bowel disease. The treatment group is compared to a waiting list control group (the results in the control group are also analyzed after the intervention). METHOD Sample group The initial evaluation of this research was carried out with a sample of 57 patients diagnosed with inflammatory bowel disease (34 with Crohn s disease and 23 with ulcerative colitis). The exclusion criteria of the sample were: being younger than 18 years, active illness at the beginning of the psychological intervention, being under psychological treatment parallel to the intervention carried out, and showing severe psychopathological rates in the questionnaires completed at treatment onset. The sample was randomly assigned to one of two experimental groups 33 were in the treatment group and 24 were assigned to the waiting list control group. As shown in table I the experimental mortality was approximately 50% after a 12-month follow-up. However, these data cannot be considered a dropout rate as they are due to factors unrelated to patients. The therapist who conducted the group psychological treatment program in Cádiz left the research project and, because of this, only a three-month follow-up was carried out with these patients. Table I. Experimental mortality in each phase of the study Group Initial Post-treatment Assessment Assessment Assessment assessment assessment 3 months 6 months 12 months Treatment group Control group Total Measurement instruments 90 symptoms questionnaire (SCL-90-R) (Derogatis, 1977). Spanish adaptation by González de Rivera et al. (20). Although this questionnaire consists of 9 psychopathological scales and 3 general uneasiness rates, it is important to point out that the statistical analyses of the present investigation were carried out only with the Anxiety and Depression scales, with the rest of scales being used as exclusion criteria. Each of the 90 items making up this questionnaire are answered on the basis of a 5- point scale (from 0 to 4), showing in this way the frequency in which each one of the symptoms developed during the last week. The result is shown in centiles and T grading, with an average of 50 and a standard deviation of 10. Beck Depression Inventory (BDI) (Beck, Rush, Shaw and Emery, 1979), Spanish adaptation by Vázquez and Sanz (21). It consists of 21 self-reported items with a high reliability and validity where the individual must select a sentence per item depending on its identification degree. The scoring range is between 0 and 63, and the different depression cutoffs are: a) non-depressive or normal, score between 0 and 9; b) mild depression, score between 10 and 18; c) moderate depression, score between 19 and 29; and d) severe depression, score between 30 and 63. Hospital Anxiety and Depression Scale (HAD) (22). This scale is used to detect depression and anxiety states in the outpatient clinic setting. The scale consists of 14 items in which the patient must mark the option with which he/she feels more identified. The result is reflected in two scores: one corresponds to depression, the other to anxiety. The scoring range is between 0 and 21 for each form, and between 0 and 42 for the overall score. The cutoff values for each two forms are: 1) 0 to

3 09. OR1099 M. A. DI?AZ SIBAJA :Maquetación 1 5/12/07 09:24 Página 595 Vol. 99. N. 10, 2007 PROTOCOLIZED COGNITIVE-BEHAVIORAL GROUP THERAPY 595 FOR INFLAMMATORY BOWEL DISEASE 7 = no emotional problem; 2) 8 to 10 = doubtful; and 3) more than 11 = clinical problem. Procedure The experimental study was made up of 5 phases: sample selection, initial assessment (pre-treatment), treatment, procedure effects assessment (post-treatment), and follow-up at 3, 6, and 12 months. Eighth and ninth sessions: by using the cognitive restructuring procedure, patients learned to register, analyze, discuss, and change negative thoughts generating anxiety and depressive feelings. Last session was a summary of all aspects learned. The goal of this session was making patients endorse the fact that they are an active, responsible, and important variable in the treatment of their illness, and that the strategies they had learned during the sessions could be used not only for illness-related problems, but also for any other problem of daily life. Group treatment The group therapy program consists of 10 weekly 2- hour sessions in a group. The structure of each session covered the following aspects: a) checking previous week homework and selfregistrations; b) education on the different factors influencing disease; c) learning and practicing each one of the therapeutic strategies; and d) homework and self-registrations. At the end of each session patients were given a dossier with a summary of the most important aspects of the session and the tasks advised for the week. In order to carry out this study a 136-page protocolized therapy manual was developed to be used by therapists, in which all records, exercises, group dynamics, tasks to be practiced at home, and education by the therapist in each of the 10 sessions were described in great detail. In order to facilitate the learning of the different relaxation procedures, and the practice of these techniques at home, a relaxation tape or CD was provided to each participant. Brief description of treatment: First session: relevant information about inflammatory bowel disease characteristics, causes, symptoms, diagnosis, and treatment possibilities. Second session: coping style model, analysis of the different factors that may influence illness, and explanation of the different coping strategies. Third session: participants learned a problem solving technique. Also in this session, the training of the "soothing breathing" technique began. Fourth session: training on "progressive muscular relaxation" began. Fifth session: the module on social skills began. The objectives were: to introduce the assertiveness concept, to remove obstacles that could interfere with assertive communication, and to improve communication between patient and physician. Sixth and seventh sessions: the patients practiced different social skills. These strategies allowed them to improve relationships with other people, their family and friends. Likewise, they were taught to use attention distraction techniques with the purpose of diminishing subjective sensations generated by symptoms. Control group Meanwhile, the control group was performing their daily self-registrations, waiting to replay post-test questionnaires and group treatment program initiation. RESULTS Given that the criteria of adjustment to the normal distribution and the analysis of homogeneity of variances was not met it was decided that Friedman s non parametric test be used. This test allows analyzing differences for each variable in the various experimental phases (pretreatment, post-treatment, and follow-up at 3, 6, and 12 months). Comparative analyses between both groups were carried out by means of theeta correlation coefficient, but only during the pre-test and post-test phases, due to the ethical problems entailed by the keeping the control group waiting for the 3, 6, and 12 months that the followup phase lasted. As seen in table II, the results obtained with the treatment group reflect a statistically significant improvement of emotional variables following the intervention. Also, such improvement persisted for almost all variables during follow-up at 3, 6, and 12 months. Regarding the control group, statistically significant differences were not seen in any of the variables between the pre-treatment phase and the post-treatment phase, with a worsening of emotional symptoms in some cases. As for the differences between both groups, there were no statistically significant differences between them. Table III shows the clinical significance of the differences observed in the emotional variables after treatment, which is reflected by a decrease in the percentage of patients within the score categories suggesting pathology, and an increase in the percentage within normality. DISCUSSION The first aspect that will be discussed regarding the emotional variables is the high percentage of patients

4 09. OR1099 M. A. DI?AZ SIBAJA :Maquetación 1 5/12/07 09:24 Página M. A. DÍAZ SIBAJA ET AL. REV ESP ENFERM DIG (Madrid) Table II. Comparisons on depression and anxiety variables between the treatment and control group Emotional Measure Group Before After 3 months 6 months 12 months Sig. variables Average Eta Average Friedman Eta Average Friedman Average Friedman Average Friedman Friedman Depression BDI Treatment * * * * (n = 33) Control (n = 14) HAD-D Treatment * * * * 0.002* (n = 33) Control (n = 14) SCL-90-D Treatment * * * * * (n = 33) Control (n = 14) Anxiety HAD-A Treatment * * * * (n = 33) Control (n = 14) SCL-90-A Treatment * * * * 0.03* (n = 33) Control (n = 14) Sig. Friedman: *= p 0,05; the difference among the different experimental stages is accepted. Friedman: * p 0,05; the difference between the pre-test and each one of the subsequent follow-ups is accepted; Eta coefficient: *= p 0,05; the difference among groups is accepted. Table III. Distribution of patients by punctuation categories in each one of the measured emotional variables (treatment group) Emotional Measure Categories Before After 3 months 6 months 12 months variables n % n % n % n % n % Depression BDI Normal Low D Moderate D Deep D HAD-D Normal Doubtful Clinical SCL-90 Low Normal High Anxiety HAD-A Normal Doubtful Clinical SCL-90 Low Normal High with psychopathological disturbances associated with inflammatory bowel disease, mainly anxiety and depression. The results of the present study reflect that the percentage of patients who were depressed at the beginning of the treatment program was very high. Above 50% of patients had scores above normality in the Beck Depression Inventory (BDI) and the depression scale of SCL-90-R (50 and 55.9%, respectively). When using the HAD depression scale, the percentage of the sample that obtained scores suggestive of depressive symptoms was slightly lower, in this case 35.2%. These results are in accordance with those described in the scientific literature in a dual sense. On the one hand, they are consistent in pointing out a high comorbidity between inflammatory bowel disease and depressive disorders, with percentages in depression being similar to those described by Blanchard et al. (1), North

5 09. OR1099 M. A. DI?AZ SIBAJA :Maquetación 1 5/12/07 09:24 Página 597 Vol. 99. N. 10, 2007 PROTOCOLIZED COGNITIVE-BEHAVIORAL GROUP THERAPY 597 FOR INFLAMMATORY BOWEL DISEASE and Alpers (2), and Díaz-Sibaja et al. (6). On the other hand, the percentage of depressed people is lower when the HAD depression scale is used, coinciding in this way with the reports by Guthrie et al. (4). The percentage difference in depression when comparing the results obtained with the BDI and the HAD scales may indicate that using only the BDI tool to measure depression in these patients may overestimate depression levels, since such inventory contains items that measure biological aspects such as weight loss, fatigue, lack of appetite, etc., symptoms all them that are characteristic of inflammatory bowel disease and possibly not motivated by a depressive disorder. Regarding anxiety disorders, data from this research have shown that 17.6 to 58.8% of patients depending on the test used have symptoms indicative of high anxiety. These results are similar to those described by García-Vega (23), who pointed out that around a third of patients with inflammatory bowel disease have emotional disorders, mainly related with anxiety or depression. The most outstanding aspect in the discussion on emotional variables refers to the fact that the psychological treatment program was effective in inducing and maintaining (at 3, 6, and 12 months) a significant improvement in all emotional variables, both in depression and anxiety. Results have demonstrated that patients who attended the psychological therapy program were less depressed and anxious following the psychological intervention. The effectiveness shown by the psychological therapy program in inducing a clinically and statistically significant improvement of emotional symptoms may be explained by the fact that patients were taught a range of effective strategies to confront the demands of their illness, thus facilitating a better adaptation to it, to increase quality of life, and to lower the potential for psychological disorders (23). The confrontation strategies related to a better prognosis of inflammatory bowel disease are those entailing active confrontation for example, search for solutions, self-control and self-help thoughts, search for social support, acceptance of and adaptation to illness, and performance of rewarding activities (24). The use of this type of strategies, considered positive for patient adjustment to illness, has also been related to lower depression scores and a better quality of life (6). It seems reasonable to conclude that the psychological therapy program was effective to improve emotional variables because of the following reasons: a) therapeutic techniques with proven effectiveness in the treatment of emotional dysfunction were used, which induced highly favorable changes at the physiological, emotional, cognitive, and behavioral levels (25); and b) patients were provided with a series of confrontation strategies, such as relaxation, cognitive restructuring or social skill training, that are effective to ease illness demands with a lower emotional cost, and to improve quality of life. Given the easy application of the present program and its optimum results, the use of a psychological intervention could be beneficial in reducing Public Health costs and also for the patient him- or herself. Nevertheless, future research is recommended to establish the differential effectiveness of each strategy included in the program, as well as a cost-benefit analysis to support this statement. REFERENCES 1. Blanchard EB, Scharff L, Schwarz SP, Suls JM, Barlow DH. The role of anxiety and depression in the irritable bowel syndrome. Behav Res Ther 1990; 28 (5): North CS, Alpers DH. A review of studies of psychiatric factors in Crohn s disease: Etiologic implications. Ann Clin Psychiatry 1994; 6 (2): Simren M, Axelsson J, Gillberg R, Abrahamsson H, Svedlund J, Bjornsson ES. Quality of life in inflammatory bowel disease in remission: the impact of IBS-like symptoms and associated psychological factors. Am J Gastroenterol 2002; 97 (2): Guthrie E, Jackson J, Shaffer J, Thompson D, Tomenson B, Creed F. Psychological disorder and severity of inflammatory bowel disease predict health-related quality of life in ulcerative colitis and Crohn s disease. 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