The Cost-Effectiveness of Cognitive-Behavioral Group Training for Patients with Unexplained Physical Symptoms.

OBJECTIVE: The aim of the study was to evaluate the cost-effectiveness of a cognitive-behavioral group training compared with a wait-list control for patients with unexplained physical symptoms (UPS). METHODS: A probabilistic decision-analytic Markov model was developed with three health states (poor health, average health, and death) based on a cutoff score of the Physical Component Summary of the short-form 36 health survey. To assess the cost-effectiveness in terms of cost per quality-adjusted life-year (QALY), a societal perspective was adopted. The model consisted of cycles of 3 months and a time horizon of 4 years. Data for the model were derived from a randomized controlled trial, in which 162 patients with UPS were randomized either to cognitive-behavioral group training or to the wait-list control. Data were assessed at baseline and after the training of 3 months or after a wait-list period of 3 months. In addition, the training group was followed in an uncontrolled phase and assessed at 3 months and 1 year after the training. RESULTS: After 4 years, the group training was in terms of cost-effectiveness "dominant" compared with the wait-list control; there was a positive effect of 0.06 QALYs and a €828 reduction in costs. The cost-effectiveness improved with a longer time horizon. A threshold of €30,000/QALY was passed after 18 months. The group training was cost saving after 33 months. CONCLUSIONS: Cognitive-behavioral group training is a cost-effective treatment compared with the wait-list control for patients with UPS.

Patients with unexplained physical symptoms have poorer quality of life and higher costs than other patient groups: a cross-sectional study on burden.

BACKGROUND: To determine whether healthcare resources are allocated fairly, it is helpful to have information on the quality of life (QoL) of patients with Unexplained Physical Symptoms (UPS) and on the costs associated with them, and on how these relate to corresponding data in other patient groups. As studies to date have been limited to specific patient populations with UPS, the objective of this study was to assess QoL and costs in a general sample of patients with UPS using generic measures. METHODS: In a cross-sectional study, 162 patients with UPS reported on their QoL, use of healthcare resources and lost productivity in paid and unpaid work. To assess QoL, the generic SF-36 questionnaire was used, from which multidimensional quality-of-life scores and a one-dimensional score (utility) using the SF-6D scorings algorithm were derived. To assess costs, the TiC-P questionnaire was used. RESULTS: Patients with UPS reported a poor QoL. Their QoL was mostly decreased by limitations in functioning due to physical health, and the least by limitations in functioning due to emotional problems. The median of utilities was 0.57, and the mean was 0.58 (SD = .09).The cost for the use of healthcare services was estimated to be €3,123 (SD = €2,952) per patient per year. This cost was enlarged by work-related costs: absence from work (absenteeism), lower on-the-job productivity (presenteeism), and paid substitution of domestic tasks. The resulting mean total cost was estimated to be €6,815 per patient per year. CONCLUSIONS: These findings suggest that patients with UPS have a high burden of disease and use a considerable amount of healthcare resources. In comparison with other patient groups, the QoL values of patients with UPS were among the poorest and their costs were among the highest of all patient groups. The burden for both patients and society helps to justify the allocation of sufficient resources to effective treatment for patients with UPS.

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

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.

Tailoring a cognitive behavioural model for unexplained physical symptoms to patient's perspective: a bottom-up approach.

The prevalence of unexplained physical symptoms (UPS) in primary care is at least 33%. Cognitive behavioural therapy has shown to be effective. Within cognitive behavioural therapy, three models can be distinguished: reattribution model, coping model and consequences model. The consequences model, labelling psychosocial stress in terms of consequences rather than as causes of UPS, has high acceptance among patients and is effective in academic medical care. This acceptance is lost when applied in primary care. To increase acceptance of the consequences model among patients in primary care, we tailor this model to patient's perspective by approaching the model from bottom-up instead of top-down. Subsequently, we use this tailored model in an easily accessible group training. We illustrate our approach using two illustrative cases.

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

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 in the daily practice of a mental healthcare institution, its transfer to practice should be relatively easy. TRIAL REGISTRATION: Nederlands Trial Register, NTR1609.

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial.

BACKGROUND: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. METHODS: In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. DISCUSSION: We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. TRIAL REGISTRATION: Dutch Trial Registry, identifier: NTR4686 , Registered on 14 July 2014.

Effective group training for patients with unexplained physical symptoms: a randomized controlled trial with a non-randomized one-year follow-up.

BACKGROUND: Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS) is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care. METHODOLOGY/PRINCIPAL FINDINGS: The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d = 0.38;p = .002), but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d = 0.43;p = 0.01), emotional (Cohen's d = 0.44;p = 0.01), and social (Cohen's d = 0.36;p = 0.01) functioning, less pain and better functioning despite pain (Cohen's d = 0.51;p = <0.001), less physical symptoms (Cohen's d = -.23;p = 0.05) and less sleep difficulties (Cohen's d = -0.25;p = 0.04) than time in the waiting group. During the non-randomized follow-ups, there were no relapses. CONCLUSIONS/SIGNIFICANCE: The cognitive-behavioral group training tailored for UPS in primary care and provided by an outreaching secondary mental-health service appears to be effective and to broaden the accessibility of treatment for UPS. TRIAL REGISTRATION: TrialRegister.nl NTR1609