The effectiveness of a training for patients with unexplained physical symptoms: protocol of a cognitive behavioral group training and randomized controlled trial

Abstract: BACKGROUND: In primary care, up to 74% of physical symptoms is classified as unexplained. These symptoms can cause high levels of distress and healthcare utilization. Cognitive behavioral therapy has shown to be effective, but does not seem to be attractive to patients. An exception herein is a therapy based on the consequences model, which distinguishes itself by its labeling of psychosocial distress in terms of consequences rather than as causes of physical symptoms. In secondary care, 81% of the patients accepts this therapy, but in primary care the outcome is poor. We assume that positive outcome can also be reached in primary care, when the consequences model is modified and used bottom-up in an easily accessible group training, in which patients are relieved of being blamed for their symptoms. Our aim is to investigate the (cost-)effectiveness of this training. METHODS AND DESIGN: A randomized controlled trial is designed. One hundred patients are randomized to either the group training or the waiting list. Physicians in general practices and outpatients clinics of general hospitals refer patients. Referral leads to inclusion if patients are between 18 and 65 years old, understand Dutch, have no handicaps impeding participation and the principal DSM-IV-TR classification is undifferentiated somatoform disorder or chronic pain disorder. In contrast to other treatment effect studies, the co-morbidity of a personality disorder does not lead to exclusion. By this, we optimize the comparability between the study population and patients in daily practice enlarging the generalization possibilities. Also in contrast to other effect studies, we chose quality of life (SF-36) instead of physical symptoms as the primary outcome measure. The SF-6D is used to estimate Quality Adjusted Life Years (QALYs). Costs are measured with the Trimbos/iMTA Questionnaire for Costs associated with Psychiatric Illness. Measurements are scheduled at baseline, after the training or waiting list, three and twelve months after the training. The differences between measurements are analyzed according to the intention-to-treat principle. The cost-effectiveness is expressed as costs per QALY, using multiple sensitivity analyses on the basis of a probabilistic model of the trial. DISCUSSION: If we show that our group training is (cost-)effective, more patients could be served, their quality of life could be improved while costs might be reduced. As the training is investigated in a heterogeneous patient group i

Predicting the outcome of a cognitive-behavioral group training for patients with unexplained physical symptoms: a one-year follow-up study

Abstract Background Although Cognitive-Behavioral Therapy (CBT) is effective for Unexplained Physical Symptoms (UPS), some therapists in clinical practice seem to believe that CBT outcome will diminish if psychiatric comorbidity is present. The result is that patients with a psychiatric comorbidity are redirected from treatment for UPS into treatment for mental health problems. To explore whether this selection and allocation are appropriate, we explored whether CBT outcomes in UPS could be predicted by variables assessed at baseline and used in routine-practice assessments. Methods Patients (n=162) with UPS classified as undifferentiated somatoform disorder or chronic pain disorder were followed up until one year after they had attended a CBT group training. The time-points of the follow-up were at the end of CBT (immediate outcome), three months after CBT (short-term outcome), and one year after CBT (long-term outcome). CBT outcome was measured using the Physical Component Summary of the SF-36, which was the primary outcome measure in the randomized controlled trial that studied effectiveness of the CBT group training. Predictors were: 1.) psychological symptoms (global severity score of SCL-90), 2.) personality-disorder characteristics (sum of DSM-IV axis II criteria confirmed), 3.) psychiatric history (past presence of DSM-IV axis I disorders), and 4.) health-related quality of life in the mental domain (mental component summary of SF-36). The effect of this predictor set was explored using hierarchical multiple regression analyses into which these predictors had been entered simultaneously, after control for: a.) pretreatment primary outcome scores, b.) age, c.) gender, d.) marital status, and e.) employment. Results The predictor set was significant only for short-term CBT outcome, where it explained 15% of the variance. A better outcome was predicted by more psychological symptoms, fewer personality-disorder characteristics, the presence of a psychiatric history, and a better quality of life in the mental domain. Conclusions As the predictors do not seem to predict CBT outcome consistently over time, the need for selection and allocation of patients for CBT is doubtful. It seems that this would unnecessarily deprive patients of effective treatment. Trial registration Nederlands Trial Register, NTR1609</p