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

INTERVENTION: Experimental group: seven 90‐minute group sessions of cognitive behavioural treatment (evidence‐based psychological techniques). The manualized protocol will include the following training: psychoeducation (on emotions and emotional disorders) and cognitive bias modification, progressive muscle relaxation, breathing skills, imagination and suggestion of relaxing images, behavioural and social skills, exposure to emotional situations and relapse prevention. Control group: treatment as usual (basically pharmacological, including muscle relaxants, pain relievers, anti‐anxiety and antidepressant medication) Joint/secondary sponsor details: Ministerio de Economía y Competitividad, Gobierno de España. https://sede.micinn.gob.es/csv/ Subdirección General de Proyectos de Investigación Calle Albacete, 5. Tel: +34 916037770 E‐mail: sgpi.secretaria@mineco.es CONDITION: Emotional disorders ; Mental and Behavioural Disorders SECONDARY OUTCOME: The experimental group but not the control group will have reduced the frequency of PC visits and psychoactive drug use (as well as other healthcare costs) at post‐treatment and 6‐month follow‐up. This will result in better, more cost‐effective services than the ones offered to the control group with usual care. This information will be obtained from patients? self‐reports and the objective data collected by the healthcare information systems at the different centres. INCLUSION CRITERIA: Any adult patient seeking treatment, regardless of his/her age and sex, with a probable anxiety, mood and/or somatisation disorder (diagnosed with the Patient Health Questionnaire) will be offered to participate in this study PRIMARY OUTCOME: When comparing the pre‐ and post‐treatment measures, the experimental group but not the control group will show a decrease in the following measures: ; 1. Self‐reported emotional symptoms (total anxiety, depression, and somatic scores as measured by the Patient Health Questionnaire (PHQ); Spitzer, Kroenke, & Williams, 1999); 2. Associated cognitive‐emotional factors, such as ruminations (measured using the 5‐item Brooding Subscale of the Ruminative Response Scale (RRS) with response options from 1 (never) to 4 (always); Nolen‐Hoeksema & Morrow, 1991); 3. Pathological worry (using 8 items from the Penn State Worry Questionnaire (PSWQ) with response options from 1 (not at all typical) to 5 (very typical); Meyer, Miller, Metzger & Borkovec, 1990); 4. Attentional and interpretive biases (using 5 items from the Inventory of Cognitive Activity in Anxiety Disorders [IACTA], with response options from 0 [almost never] to 4 [almost always]; Cano‐Vindel & Miguel‐Tobal, 2004); 6. Emotion regulation (using the 10‐item Emotion Regulation Questionnaire (ERQ) with response options from 1 (totally disagree) to 7 (totally agree); Gross & John, 2003); 7. Negative metacognitions (using the 6‐item Negative Metacognitions Subscale of the Metacognitions Questionnaire [MCQ‐30], with response options from 1 [totally disagree] to 4 [totally agree] Wells & Cartwright‐Hatton, 2004); 8. Percentage of cases with probable ED according to DSM‐IV diagnostic criteria [using the PHQ subscales: GAD‐7 (anxiety symptom severity >= 10)], with seven items, each of which is scored 0 to 3, providing a 0 to 21 severity score (Spitzer, Kroenke, Williams, & Lowe, 2006); PHQ‐9 (depression >= 10), with nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score (Kroenke, Spitzer, & Williams, 2001); PHQ‐15 (somatic symptom severity >= 5), with 15 items, each of which is scored 0 to 2, providing a 0 to 30 severity score (van Ravesteijn et al., 2009), PHQ‐PD (panic disorder >= 8), including the first 4 items (Wittkampf, Baas, van Weert, Lucassen, & Schene, 2011); 9. Their levels of work, family and social impairment (using the Sheehan Disability Scale (SDS) which is a 10‐point visual analog scale that uses spatiovisual, numeric and verbal descriptive anchors simultaneously; Sheehan, Harnett‐Sheehan, & Raj, 1996); 10. An increase in physical, psychological, social, and environmental quality of life (as measured by the different WHOQOL‐BREF scales, which includes four types of 5‐point Likert interval scales that inquire ?how much?, ?how completely?, how often?, ?how good? or ?how satisfied? the respondent felt in the last 2 weeks; Rocha, Power, Bushnell, & Fleck, 2012); These gains will be maintained at 3, 6, and 12 months follow‐up. In addition, the experimental group will report higher treatment satisfaction than the control group.