Clinical trial NCT03286881: Brief Evidence-based Psychological Treatments for Emotional Disorders
Official title: Brief Evidence-based Psychological Treatments for Emotional Disorders. A Randomized Clinical Trial in Primary and Secondary Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depression
Somatoform Disorders
Common Mental Disorders
Keywords: Common Mental Disorders
Brief Psychological Treatments
Primary Care
Randomized Clinical Trial
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2017-09-19
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Emotional disorders

Exclusion Criteria:

* Severe mental disorder
* Drug abuse
* Severe depression

Primary outcomes:
measure: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 12 weeks
measure: The State-Trait Anxiety Inventory (STAI)
timeFrame: 12 weeks
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 12 weeks
measure: Beck Depression Inventory-Second Edition (BDI-II)
timeFrame: 12 weeks
measure: The Patient Health Questionnaire (PHQ-15)
timeFrame: 12 weeks
measure: The Patient Health Questionnaire (PHQ-PD)
timeFrame: 12 weeks
measure: Brief Symptom Inventory 18 (BSI-18)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Universidad de Córdoba
state: Córdoba
Study officials:
affiliation: Universidad de Cordoba
name: Juan Antonio Moriana E
role: STUDY_DIRECTOR
References:
citation: Galvez-Lara M, Corpas J, Vencesla JF, Moriana JA. Evidence-Based Brief Psychological Treatment for Emotional Disorders in Primary and Specialized Care: Study Protocol of a Randomized Controlled Trial. Front Psychol. 2019 Jan 8;9:2674. doi: 10.3389/fpsyg.2018.02674. eCollection 2018.