A pilot study to treat emotional disorders in Primary Care with evidence-based psychological techniques: A randomized controlled trial

INTERVENTION: Product Name: Paroxetine Pharmaceutical Form: Tablet INN or Proposed INN: PAROXETINE HYDROCHLORIDE CAS Number: 78246‐49‐8 Other descriptive name: PAROXETINE HYDROCHLORIDE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 20‐50 Product Name: Fluoxetine Pharmaceutical Form: Tablet INN or Proposed INN: FLUOXETINE HYDROCHLORIDE CAS Number: 59333‐67‐4 Other descriptive name: FLUOXETINE HYDROCHLORIDE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 20‐60 Product Name: Citalopram Pharmaceutical Form: Tablet INN or Proposed INN: CITALOPRAM HYDROBROMIDE Other descriptive name: CITALOPRAM HYDROBROMIDE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 20‐60 Product Name: Sertraline Pharmaceutical Form: Tablet INN or Proposed INN: SERTRALINE HYDROCHLORIDE Other descriptive name: SERTRALINE HYDROCHLORIDE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 50‐200 Product Name: Fluvoxamine Pharmaceutical Form: Tablet INN or Proposed INN: FLUVOXAMINE MALEATE CAS Number: 61718‐82‐9 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 150‐300 Product Name: Tranylcypromine Pharmaceutical Form: Tablet INN or Proposed INN: TRANYLCYPROMINE SULFATE CAS Number: 13492‐01‐8 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 30‐60 Product Name: Vanlafaxine Pharmaceutical Form: Tablet INN or Proposed INN: VENLAFAXINE HYDROCHLORIDE Other descriptive name: VENLAFAXINE HYDROCHLORIDE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 150‐375 Product Name: Mirtazapine Pharmaceutical Form: Tablet INN or Proposed INN: MIRTAZAPINE Other descriptive name: MIRTAZAPINE Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 30‐45 Product Name: Am CONDITION: Emotional disorders specified as anxiety disorders (e.g., panic disorder, generalized anxiety disorder, social phobia, specific phobia), mood disorders (e.g., major depressive disorder, dysthymia), somatizations (e.g., somatization disorder, pain disorder) Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] SECONDARY OUTCOME: Secondary end point(s): Since there will be a follow‐up at 3, 6 and 12 months, another 12 more months would be necessary (from January 2014 to January 2015). Timepoint(s) of evaluation of this end point: Evaluation and analyses of follow‐up results will be carried out in the months following January 2015. INCLUSION CRITERIA: Any adult patient seeking Primary Care treatment at any of the selected sites, regardless of his/her age and sex, with a probable anxiety, mood and/or somatisation disorder (diagnosed with the Patient Health Questionnaire). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 1026 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100 PRIMARY OUTCOME: Main Objective: The general aim of this pilot project is to carry out a novel initiative in Spain: disseminating evidence‐based psychological treatment for emotional disorders (ED) in Primary Care. This randomized controlled trial will follow the principles of a collaborative, stepped care, group treatment with a transdiagnotic approach. It will test how well a psychological treatment programme for anxiety, depression, and somatisation disorders works in Primary Care in seven 90‐minute group sessions (experimental group) in comparison with the usual treatment offered in Spanish Primary Care services (control group). Primary end point(s): If it starts by July 2013, all the data (N = 1126) could be collected in approximately 12 months. Secondary Objective: The experimental but not the control group will report a greater decrease (including pre‐post‐treatment differences and follow‐up at 3, 6 and 12 months) in emotional symptoms (total scores of anxiety, depressive and somatic symptoms as measured by the PHQ), cognitive‐emotional factors, and percentage of cases with probable emotional disorders. The former but not the latter will also report an increase in its levels of work, family and social impairment (Sheehan Disability Scale), and physical, psychological, social, and environmental quality of life (as measured by the different WHOQOL‐BREF scales). The experimental group but not the control group will have reduced the frequency of Primary Care visits and psychoactive drug use (as well as other health care costs) at 6 month follow‐up. In addition, the experimental group will report higher treatment satisfaction than the control group. Timepoint(s) of evaluation of this end point: Evaluation and analyses of the post‐treatment results will be carried out in the months following July 2014.