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Brief Evidence-based Psychological Treatments for Common Mental Disorders (PsycBrief)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03286881
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Jorge Corpas López, Universidad de Córdoba

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Depression Somatoform Disorders Common Mental Disorders Other: Brief psychotherapy Other: Extensive psychotherapy Other: Combined intervention Other: Minimum psychological intervention Other: Usual treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Brief Evidence-based Psychological Treatments for Common Mental Disorders. A Randomized Clinical Trial in Primary and Secondary Care.
Study Start Date : January 15, 2017
Estimated Primary Completion Date : January 15, 2018
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1 Other: Brief psychotherapy
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.

Experimental: Group 2 Other: Extensive psychotherapy
Usual psychological intervention in secondary care provided by a clinical psychologist.

Experimental: Group 3 Other: Combined intervention
Extensive psychotherapy and medication provided by a clinical psychologist and a psychiatrist.

Experimental: Group 4 Other: Minimum psychological intervention
Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.

Active Comparator: Group 5 Other: Usual treatment
Medication provided by a general practitioner.

Primary Outcome Measures :
  1. Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: 12 weeks ]
    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.

  2. The State-Trait Anxiety Inventory (STAI) [ Time Frame: 12 weeks ]
    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).

  3. The Patient Health Questionnaire (PHQ-9) [ Time Frame: 12 weeks ]
    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).

  4. Beck Depression Inventory-Second Edition (BDI-II) [ Time Frame: 12 weeks ]
    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.

  5. The Patient Health Questionnaire (PHQ-15) [ Time Frame: 12 weeks ]
    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).

  6. The Patient Health Questionnaire (PHQ-PD) [ Time Frame: 12 weeks ]
    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".

  7. Brief Symptom Inventory 18 (BSI-18) [ Time Frame: 12 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Common mental disorder

Exclusion Criteria:

  • Severe mental disorder
  • Drug abuse
  • Severe depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03286881

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Contact: Jorge C López 654732504
Contact: Juan Antonio Moriana

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Universidad de Córdoba Recruiting
Cordoba, Córdoba, Spain, 14071
Contact: Jorge C López    654732504      
Principal Investigator: Juan Antonio M Elvira         
Sponsors and Collaborators
Universidad de Córdoba
Ministerio de Economía y Competitividad, Spain
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Study Director: Juan Antonio Moriana E Universidad de Cordoba

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jorge Corpas López, Investigator, Universidad de Córdoba Identifier: NCT03286881     History of Changes
Other Study ID Numbers: PSI2014-56368-R
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Jorge Corpas López, Universidad de Córdoba:
Common Mental Disorders
Brief Psychological Treatments
Primary Care
Randomized Clinical Trial

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Psychotic Disorders
Somatoform Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders