Brief Evidence-based Psychological Treatments for Emotional Disorders

Study Overview
=================
Brief Summary
-----------------
The present work aims to develop a randomized clinical trial with a sample of 165 patients diagnosed with an emotional disorder. All participants are tested by several self-reports related to common mental disorders in a repeated measures design, pre and post treatment as well as a six month follow up. We think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life while simultaneously reducing costs.

Detailed Description
-----------------
Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called common mental disorders and their mostly pharmacological treatment are, in no small part, responsible for this situation. The cost that these disorders generate to the public health service is very high and they are usually associated with other issues like hyperfrequentation and side effects. However, research indicates that psychological treatment should be the first step when caring for these types of problems. We expect that the results show that extensive psychological therapy and combined treatment were the most effective. Nevertheless, brief psychological treatment is expected to be the most efficient in cost-benefit terms.

Official Title
-----------------
Brief Evidence-based Psychological Treatments for Emotional Disorders. A Randomized Clinical Trial in Primary and Secondary Care.

Conditions
-----------------
Depression, Somatoform Disorders, Anxiety Disorders, Common Mental Disorders

Intervention / Treatment
-----------------
* Other: Brief individual psychotherapy
* Other: Brief group psychotherapy
* Other: Combined intervention
* Other: Minimum psychological intervention
* Other: Usual treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emotional disorders Exclusion Criteria: Severe mental disorder Drug abuse Severe depression

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Other: Brief individual psychotherapy<br>* Individual brief psychological intervention by adaptation of the Guide NICE Common Mental Health Disorders (ISBN 978-1-84936-585-7) and the unified protocol for the trasndiagnostic treatment of the emotional disorders of Barlow (Boisseau, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in secondary care.<br>|
| Experimental: Group 2<br> | Other: Brief group psychotherapy<br>* Group brief psychological intervention by adaptation of the Guide NICE Common Mental Health Disorders (ISBN 978-1-84936-585-7) and the unified protocol for the trasndiagnostic treatment of the emotional disorders of Barlow (Boisseau, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in primary care.<br>|
| Experimental: Group 3<br> | Other: Combined intervention<br>* Traditional psychotherapy and medication provided by a clinical psychologist and a psychiatrist in secondary care.<br>|
| Experimental: Group 4<br> | Other: Minimum psychological intervention<br>* Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.<br>|
| Active Comparator: Group 5<br> | Other: Usual treatment<br>* Medication provided by a general practitioner.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalised Anxiety Disorder Assessment (GAD-7) | The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. | 12 weeks | 
| The State-Trait Anxiety Inventory (STAI) | The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress AnxietyForm Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from Almost Never to Almost Always). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983). | 12 weeks | 
| The Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). | 12 weeks | 
| Beck Depression Inventory-Second Edition (BDI-II) | The BDI-II is a widely used 21-item self-report inventory measuring the severity of depression in adolescents and adults. The BDI-II was revised in 1996 to be more consistent with DSM-IV criteria for depression. For example, individuals are asked to respond to each question based on a two-week time period rather than the one-week timeframe on the BDI. The BDI-II is widely used as an indicator of the severity of depression, but not as a diagnostic tool, and numerous studies provide evidence for its reliability and validity across different populations and cultural groups. | 12 weeks | 
| The Patient Health Questionnaire (PHQ-15) | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-15 is the somatization module, which scores each DSM-IV criteria as 0 (not bothered at all) to 2 (bothered a lot). | 12 weeks | 
| The Patient Health Questionnaire (PHQ-PD) | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-PD is the panic disorder module, which scores each DSM-IV criteria as yes or no. | 12 weeks | 
| Brief Symptom Inventory 18 (BSI-18) | The BSI-18 contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensional versions of the Symptom-Checklist 90-R. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brief Psychological Treatments, Primary Care, Randomized Clinical Trial, Common Mental Disorders