Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

Abstract

BackgroundMedically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month.Methods/designThis study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis.DiscussionThis study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations.Trial registrationThe trial was registered with ClinicalTrials.gov, number NCT01484223 [ http://ClinicalTrials.gov].

Specific Collaborative Group Intervention for Patients with Medically Unexplained Symptoms in General Practice: A Cluster Randomized Controlled Trial

“…The ITT analyses showed that at 12 months, the intervention resulted in a clinically meaningful change in patients’ mental QoL [59,60,61] without improving physical QoL. Among the SF-36 domains, vitality, emotional role functioning and general health perceptions were significantly improved at 12 months.…”

“…The between-group ES for the MCS was 0.31 in the ITT analysis and 0.37 in the PP analysis. With regard to clinical change, 55% of patients in the treatment group versus 34% in the control group improved by 4 or more points on the MCS (odds ratio 2.27, 95% confidence interval 1.19–4.34; number needed to treat = 4.8), which has been used to determine the clinical change in MUS in primary care [59,60,61]. Regarding the SF-36 domains at 12 months, further ITT analyses showed between-group effects among the SF-36 mental domains of vitality (p = 0.012) and emotional role functioning (p = 0.021) and among the SF-36 physical domain of general health perceptions (p = 0.020; online supplementary table A, www.karger.com?doi=10.1159/000343652).…”

Psychiatric Aspects of Medically Unexplained Symptoms

“…Bu hasta grubunda en yaygın terapiler davranışçı ve bilişsel-davranışçı tedaviler, farkındalık yaratma ve psikoeğitimdir. [89][90][91][92][93] …”