<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/NCT04428099</url>
  </required_header>
  <id_info>
    <org_study_id>RMD01</org_study_id>
    <nct_id>NCT04428099</nct_id>
  </id_info>
  <brief_title>Healthy Lifestyle Promotion as Adjunctive Teletherapy for Treatment-resistant Major Depression</brief_title>
  <official_title>Effectiveness of a Healthy Lifestyle Promotion Program as Adjunctive Teletherapy for Treatment-resistant Major Depression During Covid 19 Pandemic: A Randomized Clinical Trial Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Balearic Islands</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Balearic Islands</source>
  <oversight_info>
    <has_dmc>No</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 main objective of the study will be to evaluate the effectiveness of an adjuvant&#xD;
      lifestyle-based intervention for treatment-resistant patients with major depressive disorder.&#xD;
      Patients will be allocated to one of these three groups: 1)Treatment prescribed by their&#xD;
      mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their&#xD;
      mental health team plus written lifestyle change suggestions plus 8-week Mindfulness-based&#xD;
      cognitive therapy (MBCT) program 3) Treatment prescribed by their mental health team plus&#xD;
      written lifestyle change suggestions plus 8-week lifestyle change promotion program. We will&#xD;
      collect patient data using the questionnaires administered at baseline, immediately after the&#xD;
      intervention, and at six and 12-month follow-up. The primary outcome will be depression&#xD;
      severity and secondary outcomes will include health-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is a very prevalent, incapacitating illness. The treatment available&#xD;
      (psychotherapy and drug therapy) do not always manage to achieve complete remission of the&#xD;
      symptoms or prevent its relapses or recurrences. For that reason, it is still necessary to&#xD;
      investigate new adjuvant therapeutic antidepressant alternatives, especially if they can add&#xD;
      efficacy to the treatment without reducing tolerance and safety. In the last few years, data&#xD;
      have been growing about the usefulness of having patients who are depressed make specific&#xD;
      changes in their lifestyles.&#xD;
&#xD;
      The main objective of the study will be to evaluate the effectiveness and efficiency of an&#xD;
      adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive&#xD;
      disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by&#xD;
      their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by&#xD;
      their mental health team plus written lifestyle change suggestions plus 8-week MBCT program&#xD;
      3) Treatment prescribed by their mental health team plus written lifestyle change suggestions&#xD;
      plus 8-week lifestyle change promotion program. Two control groups were designed:&#xD;
      placebo-control (written lifestyle change suggestion) and active-control (MBCT). We selected&#xD;
      this adjuvant therapy because MBCT has shown positive results as an adjunctive treatment for&#xD;
      resistant depression in previous studies and it could be administered in a similar format as&#xD;
      our intervention (8-weeks lifestyle change promotion program). We hypothesize that the&#xD;
      lifestyle change promotion program at 12 months of follow-up will be more effective because&#xD;
      patients will have better adherence to this intervention than to MBCT.&#xD;
&#xD;
      This study will be carried out during the COVID-19 pandemic, therefore the administration of&#xD;
      the intervention will be administered by teletherapy. Different ways and technologies will be&#xD;
      used to contact participants remotely: telephone calls, text messages, WhatsApp groups, and&#xD;
      teleconferences.&#xD;
&#xD;
      We will collect patient data using the questionnaires administered at baseline, immediately&#xD;
      after the intervention, and at six and 12-month follow-up. The primary outcome will be&#xD;
      measured using the Beck Depression Inventory-II (BDI-II). Secondary outcomes will include&#xD;
      Clinical Global Impressions (CGI) Scale, to quantify and track patient progress and treatment&#xD;
      response over time and Health-related quality of life measured using the European Quality of&#xD;
      Life-5 Dimensions Questionnaire (EQ-5D).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 13, 2020</start_date>
  <completion_date type="Anticipated">July 12, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 12, 2022</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression severity</measure>
    <time_frame>12 month</time_frame>
    <description>Beck Depression Inventory-II (BDI-II)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>12 month</time_frame>
    <description>Questionnaire (EQ-5D)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">186</enrollment>
  <condition>Depressive Disorder, Treatment-Resistant</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lifestyle change promotion program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MBCT program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle change promotion program</intervention_name>
    <description>The intervention consists of 8 group sessions centered on healthy physical activity, healthy diet, social life, Good Sleep Hygiene, healthy sun exposure, nature contact, how to stop ruminating, review and maintenance tips.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfullness based cognitive program</intervention_name>
    <description>The intervention consists of 8 group sessions with a mindfulness-based cognitive program</description>
    <arm_group_label>Control 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Written Information</intervention_name>
    <description>Written information about lifestyle change suggestions</description>
    <arm_group_label>Control 1</arm_group_label>
    <arm_group_label>Control 2</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals aged 18 or older.&#xD;
&#xD;
          -  Diagnosis of Major Depressive Disorder as stated by the DSM-5.&#xD;
&#xD;
          -  Two previous treatment failures (non-response to an adequate dose of potentially&#xD;
             effective medication for an adequate length of time or treatment intolerance or&#xD;
             refusal) in the current episode.&#xD;
&#xD;
          -  At least one month of treatment with a psychiatrist and/or psychologist in the current&#xD;
             episode.&#xD;
&#xD;
          -  Physical and cognitive aptitudes to understand and give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbidity with other medical conditions which would affect the Central Nervous&#xD;
             System (CNS).&#xD;
&#xD;
          -  Other severe psychiatric disorders (except for anxiety disorders or personality&#xD;
             disorders)&#xD;
&#xD;
          -  Other non-controlled severe medical diseases, infectious or degenerative which would&#xD;
             interfere with affective symptomatology or the adherence to the hygienic-dietary&#xD;
             recommendations.&#xD;
&#xD;
          -  Patients with delusions or hallucinations which are congruent or non-congruent with&#xD;
             mood.&#xD;
&#xD;
          -  Patients with an important risk for suicide&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mauro García-Toro, PhD</last_name>
    <phone>+34 971 259966</phone>
    <email>mauro.garcia@uib.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitat Illes Balears</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Illes Balears</state>
        <zip>07122</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mauro García-Toro, PhD</last_name>
      <phone>971 259966</phone>
      <email>mauro.garcia@uib.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heallthy Lifestyle</keyword>
  <keyword>Minfullness based cognitive therapy</keyword>
  <keyword>Teletherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Treatment-Resistant</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/NCT04428099
org study id: RMD01
nct id: NCT04428099
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of the study will be to evaluate the effectiveness of an adjuvant
      lifestyle-based intervention for treatment-resistant patients with major depressive disorder.
      Patients will be allocated to one of these three groups: 1)Treatment prescribed by their
      mental health team plus written lifestyle change suggestions 2)Treatment prescribed by their
      mental health team plus written lifestyle change suggestions plus 8-week Mindfulness-based
      cognitive therapy (MBCT) program 3) Treatment prescribed by their mental health team plus
      written lifestyle change suggestions plus 8-week lifestyle change promotion program. We will
      collect patient data using the questionnaires administered at baseline, immediately after the
      intervention, and at six and 12-month follow-up. The primary outcome will be depression
      severity and secondary outcomes will include health-related quality of life.
Depression is a very prevalent, incapacitating illness. The treatment available
      (psychotherapy and drug therapy) do not always manage to achieve complete remission of the
      symptoms or prevent its relapses or recurrences. For that reason, it is still necessary to
      investigate new adjuvant therapeutic antidepressant alternatives, especially if they can add
      efficacy to the treatment without reducing tolerance and safety. In the last few years, data
      have been growing about the usefulness of having patients who are depressed make specific
      changes in their lifestyles.

      The main objective of the study will be to evaluate the effectiveness and efficiency of an
      adjuvant lifestyle-based intervention for treatment-resistant patients with major depressive
      disorder. Patients will be allocated to one of these three groups: 1)Treatment prescribed by
      their mental health team plus written lifestyle change suggestions 2)Treatment prescribed by
      their mental health team plus written lifestyle change suggestions plus 8-week MBCT program
      3) Treatment prescribed by their mental health team plus written lifestyle change suggestions
      plus 8-week lifestyle change promotion program. Two control groups were designed:
      placebo-control (written lifestyle change suggestion) and active-control (MBCT). We selected
      this adjuvant therapy because MBCT has shown positive results as an adjunctive treatment for
      resistant depression in previous studies and it could be administered in a similar format as
      our intervention (8-weeks lifestyle change promotion program). We hypothesize that the
      lifestyle change promotion program at 12 months of follow-up will be more effective because
      patients will have better adherence to this intervention than to MBCT.

      This study will be carried out during the COVID-19 pandemic, therefore the administration of
      the intervention will be administered by teletherapy. Different ways and technologies will be
      used to contact participants remotely: telephone calls, text messages, WhatsApp groups, and
      teleconferences.

      We will collect patient data using the questionnaires administered at baseline, immediately
      after the intervention, and at six and 12-month follow-up. The primary outcome will be
      measured using the Beck Depression Inventory-II (BDI-II). Secondary outcomes will include
      Clinical Global Impressions (CGI) Scale, to quantify and track patient progress and treatment
      response over time and Health-related quality of life measured using the European Quality of
      Life-5 Dimensions Questionnaire (EQ-5D).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Depression severity
time frame: 12 month
description: Beck Depression Inventory-II (BDI-II)
measure: Health-related quality of life
time frame: 12 month
description: Questionnaire (EQ-5D)
arm group label: Intervention
arm group type: Experimental
description: Lifestyle change promotion program
arm group label: Control 1
arm group type: Active Comparator
description: MBCT program
arm group label: Control 2
arm group type: Placebo Comparator
description: Usual care
intervention type: Behavioral
intervention name: Lifestyle change promotion program
description: The intervention consists of 8 group sessions centered on healthy physical activity, healthy diet, social life, Good Sleep Hygiene, healthy sun exposure, nature contact, how to stop ruminating, review and maintenance tips.
arm group label: Intervention
intervention type: Behavioral
intervention name: Mindfullness based cognitive program
description: The intervention consists of 8 group sessions with a mindfulness-based cognitive program
arm group label: Control 1
intervention type: Behavioral
intervention name: Written Information
description: Written information about lifestyle change suggestions
arm group label: Control 1
arm group label: Control 2
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mauro García-Toro, PhD
phone: +34 971 259966
email: mauro.garcia@uib.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Treatment-Resistant