<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/NCT04489641</url>
  </required_header>
  <id_info>
    <org_study_id>Interventional</org_study_id>
    <nct_id>NCT04489641</nct_id>
  </id_info>
  <brief_title>Brief Group Psychotherapy for Anxiety and Depression</brief_title>
  <official_title>Brief Group Psychotherapy for Anxiety and Depression: A Randomized Controlled Trial of Efficacy and Mechanisms of Change</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Córdoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Córdoba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present work aims to develop a randomized clinical trial with a sample of 100 patients&#xD;
      diagnosed with anxiety and depression in primary care. All participants are tested by several&#xD;
      self-reports related to emotional disorders in a repeated measures design, pre and post&#xD;
      treatment. It is our aim this study will demonstrate that brief psychological treatments&#xD;
      should be prioritized over pharmacological treatment in Primary Care. In addition, emotional&#xD;
      regulation will be assessed and examined as a key factor in the clinical improvement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2020</start_date>
  <completion_date type="Actual">December 16, 2020</completion_date>
  <primary_completion_date type="Actual">November 16, 2020</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>Single (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 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>It asseses somatoform symptoms. Scores could vary between 0-30 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire-Panic Disorder (PHQ-PD)</measure>
    <time_frame>12 weeks</time_frame>
    <description>It measures panic disorder symotmos. Scores vould vary between 0-15 points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotional Regulation Questionnaire (ERQ)</measure>
    <time_frame>12 weeks</time_frame>
    <description>It evaluates the tendency to regulate emotions. It consists of 10 items and participants have to respond according to a 7-points Likert scale. It has two subscales: reappraisal and suppression (six and four items respectively). The reappraisal subscale assesses the ability to change negative emotions while the suppression subscale assesses the tendency to repress and hide negative emotions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn State Worry Questionnaire-Abbreviated (PSWQ-A)</measure>
    <time_frame>12 weeks</time_frame>
    <description>It assesses the tendency to experience worry. It consists of eight items and patients have to respond according to a 5-point Likert-type scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ruminative Response Scale-10 (RRS-10)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The RRS is the most used measure of rumination. The short version consists of 10 items that are responded on a 4-point Likert-type scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metacognition Questionnaire-30 (MCQ-30)</measure>
    <time_frame>12 weeks</time_frame>
    <description>This instrument has been used to assess metacognitive beliefs. It consists of 30 items that are responded on a 4-point Likert-type scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Affective Disorder</condition>
  <arm_group>
    <arm_group_label>Brief group psychotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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 et al., 2010). This intervention is provided by clinical psychologist in primary care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual (TAU)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medication provided by a general practitioner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychological treatment</intervention_name>
    <description>Psychological treatment</description>
    <arm_group_label>Brief group psychotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medication</intervention_name>
    <description>Pharmacological intervention</description>
    <arm_group_label>Treatment as usual (TAU)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anxiety&#xD;
&#xD;
          -  Depression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe mental disroders&#xD;
&#xD;
          -  Drug abuse&#xD;
&#xD;
          -  Suicidal ideation/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 A. Moriana</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Córdoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jorge Corpas</name>
      <address>
        <city>Córdoba</city>
        <state>Andalucía</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</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>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mood 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/NCT04489641
org study id: Interventional
nct id: NCT04489641
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present work aims to develop a randomized clinical trial with a sample of 100 patients
      diagnosed with anxiety and depression in primary care. All participants are tested by several
      self-reports related to emotional disorders in a repeated measures design, pre and post
      treatment. It is our aim this study will demonstrate that brief psychological treatments
      should be prioritized over pharmacological treatment in Primary Care. In addition, emotional
      regulation will be assessed and examined as a key factor in the clinical improvement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (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 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: It asseses somatoform symptoms. Scores could vary between 0-30 points.
measure: Patient Health Questionnaire-Panic Disorder (PHQ-PD)
time frame: 12 weeks
description: It measures panic disorder symotmos. Scores vould vary between 0-15 points.
measure: Emotional Regulation Questionnaire (ERQ)
time frame: 12 weeks
description: It evaluates the tendency to regulate emotions. It consists of 10 items and participants have to respond according to a 7-points Likert scale. It has two subscales: reappraisal and suppression (six and four items respectively). The reappraisal subscale assesses the ability to change negative emotions while the suppression subscale assesses the tendency to repress and hide negative emotions.
measure: Penn State Worry Questionnaire-Abbreviated (PSWQ-A)
time frame: 12 weeks
description: It assesses the tendency to experience worry. It consists of eight items and patients have to respond according to a 5-point Likert-type scale.
measure: Ruminative Response Scale-10 (RRS-10)
time frame: 12 weeks
description: The RRS is the most used measure of rumination. The short version consists of 10 items that are responded on a 4-point Likert-type scale.
measure: Metacognition Questionnaire-30 (MCQ-30)
time frame: 12 weeks
description: This instrument has been used to assess metacognitive beliefs. It consists of 30 items that are responded on a 4-point Likert-type scale.
arm group label: Brief group psychotherapy
arm group type: Experimental
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 et al., 2010). This intervention is provided by clinical psychologist in primary care.
arm group label: Treatment as usual (TAU)
arm group type: Active Comparator
description: Medication provided by a general practitioner.
intervention type: Behavioral
intervention name: Psychological treatment
description: Psychological treatment
arm group label: Brief group psychotherapy
intervention type: Drug
intervention name: Medication
description: Pharmacological intervention
arm group label: Treatment as usual (TAU)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Juan A. Moriana
role: Principal Investigator
affiliation: Universidad de Córdoba
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Córdoba
investigator full name: Jorge Corpas López
investigator title: Clinical Professor
mesh term: Mood Disorders