<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286881</url>
  </required_header>
  <id_info>
    <org_study_id>PSI2014-56368-R</org_study_id>
    <nct_id>NCT03286881</nct_id>
  </id_info>
  <brief_title>Brief Evidence-based Psychological Treatments for Emotional Disorders</brief_title>
  <acronym>PsycBrief</acronym>
  <official_title>Brief Evidence-based Psychological Treatments for Emotional Disorders. A Randomized Clinical Trial in Primary and Secondary Care.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Córdoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Economía y Competitividad, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Córdoba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present work aims to develop a randomized clinical trial with a sample of 165 patients&#xD;
      diagnosed with an emotional disorder. All participants are tested by several self-reports&#xD;
      related to common mental disorders in a repeated measures design, pre and post treatment as&#xD;
      well as a six month follow up. We think this study will demonstrate that brief psychological&#xD;
      treatments should be prioritized over pharmacological treatment for such pathologies in the&#xD;
      Primary or Secondary Care context to improve the patient´s quality of life while&#xD;
      simultaneously reducing costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nowadays, the heavy demands placed on health systems exceed the resources in many developed&#xD;
      countries. So-called &quot;common mental disorders&quot; and their mostly pharmacological treatment&#xD;
      are, in no small part, responsible for this situation. The cost that these disorders generate&#xD;
      to the public health service is very high and they are usually associated with other issues&#xD;
      like hyperfrequentation and side effects. However, research indicates that psychological&#xD;
      treatment should be the first step when caring for these types of problems. We expect that&#xD;
      the results show that extensive psychological therapy and combined treatment were the most&#xD;
      effective. Nevertheless, brief psychological treatment is expected to be the most efficient&#xD;
      in cost-benefit terms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">April 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Generalised Anxiety Disorder Assessment (GAD-7)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, &amp; 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 &quot;Almost Never&quot; to &quot;Almost Always&quot;). 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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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 &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck Depression Inventory-Second Edition (BDI-II)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Patient Health Questionnaire (PHQ-15)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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 &quot;0&quot; (not bothered at all) to &quot;2&quot; (bothered a lot).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Patient Health Questionnaire (PHQ-PD)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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 &quot;yes&quot; or &quot;no&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Symptom Inventory 18 (BSI-18)</measure>
    <time_frame>12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Anxiety Disorders</condition>
  <condition>Depression</condition>
  <condition>Somatoform Disorders</condition>
  <condition>Common Mental Disorders</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brief individual psychotherapy</intervention_name>
    <description>Individual brief psychological intervention by adaptation of the Guide NICE &quot;Common Mental Health Disorders&quot; (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.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brief group psychotherapy</intervention_name>
    <description>Group brief psychological intervention by adaptation of the Guide NICE &quot;Common Mental Health Disorders&quot; (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.</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combined intervention</intervention_name>
    <description>Traditional psychotherapy and medication provided by a clinical psychologist and a psychiatrist in secondary care.</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Minimum psychological intervention</intervention_name>
    <description>Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.</description>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual treatment</intervention_name>
    <description>Medication provided by a general practitioner.</description>
    <arm_group_label>Group 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emotional disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe mental disorder&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Severe depression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Antonio Moriana E</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Cordoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad de Córdoba</name>
      <address>
        <city>Cordoba</city>
        <state>Córdoba</state>
        <zip>14071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Córdoba</investigator_affiliation>
    <investigator_full_name>Jorge Corpas López</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Common Mental Disorders</keyword>
  <keyword>Brief Psychological Treatments</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Randomized Clinical Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286881
org study id: PSI2014-56368-R
nct id: NCT03286881
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: Generalised Anxiety Disorder Assessment (GAD-7)
time frame: 12 weeks
description: 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.
measure: The State-Trait Anxiety Inventory (STAI)
time frame: 12 weeks
description: 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).
measure: The Patient Health Questionnaire (PHQ-9)
time frame: 12 weeks
description: 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).
measure: Beck Depression Inventory-Second Edition (BDI-II)
time frame: 12 weeks
description: 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.
measure: The Patient Health Questionnaire (PHQ-15)
time frame: 12 weeks
description: 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).
measure: The Patient Health Questionnaire (PHQ-PD)
time frame: 12 weeks
description: 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".
measure: Brief Symptom Inventory 18 (BSI-18)
time frame: 12 weeks
description: 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.
arm group label: Group 1
arm group type: Experimental
arm group label: Group 2
arm group type: Experimental
arm group label: Group 3
arm group type: Experimental
arm group label: Group 4
arm group type: Experimental
arm group label: Group 5
arm group type: Active Comparator
intervention type: Other
intervention name: Brief individual psychotherapy
description: 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.
arm group label: Group 1
intervention type: Other
intervention name: Brief group psychotherapy
description: 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.
arm group label: Group 2
intervention type: Other
intervention name: Combined intervention
description: Traditional psychotherapy and medication provided by a clinical psychologist and a psychiatrist in secondary care.
arm group label: Group 3
intervention type: Other
intervention name: Minimum psychological intervention
description: Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.
arm group label: Group 4
intervention type: Other
intervention name: Usual treatment
description: Medication provided by a general practitioner.
arm group label: Group 5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Juan Antonio Moriana E
role: Study Director
affiliation: Universidad de Cordoba
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Córdoba
investigator full name: Jorge Corpas López
investigator title: Investigator
mesh term: Anxiety Disorders
mesh term: Mental Disorders
mesh term: Psychotic Disorders
mesh term: Somatoform Disorders