<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/NCT03272516</url>
  </required_header>
  <id_info>
    <org_study_id>UI-2017-MBCT.</org_study_id>
    <nct_id>NCT03272516</nct_id>
  </id_info>
  <brief_title>Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients</brief_title>
  <official_title>Mindfulness Based Cognitive Therapy (MBCT) for Primary Care Patients With Mild to Moderate Symptoms of Depression or Anxiety.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iceland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iceland</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>
      This study is done to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) for&#xD;
      primary care patients that have mild to moderate symptoms of depression and anxiety. Half of&#xD;
      the study participants will receive treatment as usual (TAU), and the other half will receive&#xD;
      TAU plus MBCT. The investigators will be comparing changes in symptoms of depression and&#xD;
      anxiety between the groups, and hypothesize that the TAU plus MBCT group will have&#xD;
      significantly lower symptoms of depression and anxiety compared to TAU group&#xD;
      post-intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients that show mild to moderate symptoms of depression and anxiety are common in the&#xD;
      primary care setting. These patients are often treated with antidepressant or anxiolytic&#xD;
      medication instead of cognitive therapy, which is the first choice of treatment according to&#xD;
      clinical guidelines in Iceland. Although these patients are often referred to cognitive&#xD;
      therapy, there are long waiting lists for group therapy and personal therapy is expensive.&#xD;
      MBCT has been shown to have good effects on people with recurrent depression and on patients&#xD;
      suffering from anxiety. Therefore, the investigators main objective is to assess whether MBCT&#xD;
      is effective in the primary care setting for patients with mild symptoms of anxiety and&#xD;
      depression and compare its effect to TAU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">October 21, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2019</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>
    <intervention_model_description>Randomized clinical trial, where patients are randomized to two groups. Group 1 receives treatment as usual, group 2 receives treatment as usual plus Mindfulness Based Cognitive Therapy (MBCT) for symptoms of mild to moderate depression or anxiety.&#xD;
Our primary aim is to investigate whether MBCT added to TAU is more effective than TAU alone in reducing mild to moderate symptoms of depression and/or anxiety among primary care patients.&#xD;
Our secondary aim is to investigate whether MBCT added to TAU is more effective than TAU alone in:&#xD;
Increasing subjective wellbeing&#xD;
Reducing antidepressant/anxiolytica use for primary care patients, with mild to moderate symptoms of depression and/or anxiety.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The investigator will contact all participants in both groups via email or telephone to ask them to answer questionnaires.The investigator will not have information about which group which participant is. Participants will be contacted and invited to answer a questionnaire before, after, 6 and 18 months after 8 weeks of TAU and TAU plus MBCT.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Symptoms of depression measured with the PHQ-9 questionnaire</measure>
    <time_frame>up to 18 months</time_frame>
    <description>Comparing scores on the PHQ-9 before and after the intervention as well as, 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptoms of anxiety measured with the GAD-7 questionnaire</measure>
    <time_frame>up to 18 months</time_frame>
    <description>Comparing scores on the GAD-7 before and after the intervention as well as 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective well-being measured with the SWEMWBS questionnaire</measure>
    <time_frame>up to 18 months</time_frame>
    <description>Comparing overall score on the SWEMWBS before and after the intervention as well as 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in use of antidepressants</measure>
    <time_frame>up to 18 months</time_frame>
    <description>Self reported use of antidepressants in a questionnaire sent out by the study organization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in use of anxiolytics</measure>
    <time_frame>up to 18 months</time_frame>
    <description>Self reported use of antidepressants in a questionnaire sent out by the study organization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Depression, Anxiety</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group receives treatment as usual (TAU) from his/hers physician. This treatment is different for each physician, but mainly consists of cognitive therapy, personal interviews or antidepressants or anxiolytics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol..</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness based cognitive therapy (MBCT)</intervention_name>
    <description>Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual (TAU)</intervention_name>
    <description>Usual treatment prescribed by each physician, specifically interview therapy, cognitive therapy, antidepressants and/or anxiolytics as well as a mixture of all of the above.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PHQ-9 and GAD-7 score 5-14 points&#xD;
&#xD;
          -  Age18 - 67&#xD;
&#xD;
          -  No current/recent psychotherapy of any kind other than his/hers physicians therapy(&#xD;
             can be taking antidepressants but not in CBT)&#xD;
&#xD;
          -  No regular meditation or yoga practice&#xD;
&#xD;
          -  Not mentally retarded&#xD;
&#xD;
          -  Speaks and understands Icelandic&#xD;
&#xD;
          -  No current substance dependence&#xD;
&#xD;
          -  Not diagnosed with schizophrenic symptoms or bipolar disease that that currently&#xD;
             requires treatment&#xD;
&#xD;
          -  Not participating in another mental health study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age: &lt;18 and &gt;67 years old.&#xD;
&#xD;
          2. Severe psychiatric symptoms requiring psychiatric care&#xD;
&#xD;
          3. Risk of suicide&#xD;
&#xD;
          4. Inability to participate in group sessions because of severe substance misuse;&#xD;
&#xD;
          5. Inability to speak and understand Icelandic&#xD;
&#xD;
          6. Pregnancy;&#xD;
&#xD;
          7. Current psychotherapy of any kind;&#xD;
&#xD;
          8. Participation in any other psychiatric intervention study;&#xD;
&#xD;
          9. Thyroid disease (if newly diagnosed by the doctor).&#xD;
&#xD;
         10. Score under 5 on both GAD7 and PHQ-9 and score over 14 on either GAD7 or PHQ-9.&#xD;
&#xD;
         11. One or more of the following ICD-10 psychiatric diagnoses:&#xD;
&#xD;
        F00-F09 Organic, including symptomatic, mental disorders F10-F19 Mental and behavioural&#xD;
        disorders due to psychoactive substance use F20-F29 Schizophrenia, schizotypal and&#xD;
        delusional disorders F70-F79 Mental retardation&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dóra G Gudmundsdóttir, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Directorate of Health, Iceland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heilsugæslan Grafarvogi</name>
      <address>
        <city>Reykjavík</city>
        <state>Grafarvogur</state>
        <zip>112</zip>
        <country>Iceland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heilsugæslan Miðbæ</name>
      <address>
        <city>Reykjavík</city>
        <zip>101</zip>
        <country>Iceland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iceland</country>
  </location_countries>
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  <reference>
    <citation>Piet J, Hougaard E. The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Clin Psychol Rev. 2011 Aug;31(6):1032-40. doi: 10.1016/j.cpr.2011.05.002. Epub 2011 May 15.</citation>
    <PMID>21802618</PMID>
  </reference>
  <reference>
    <citation>Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.</citation>
    <PMID>16717171</PMID>
  </reference>
  <reference>
    <citation>Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.</citation>
    <PMID>16443717</PMID>
  </reference>
  <reference>
    <citation>Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, Hayes R, Huijbers M, Ma H, Schweizer S, Segal Z, Speckens A, Teasdale JD, Van Heeringen K, Williams M, Byford S, Byng R, Dalgleish T. Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse: An Individual Patient Data Meta-analysis From Randomized Trials. JAMA Psychiatry. 2016 Jun 1;73(6):565-74. doi: 10.1001/jamapsychiatry.2016.0076.</citation>
    <PMID>27119968</PMID>
  </reference>
  <results_reference>
    <citation>Ansseau M, Dierick M, Buntinkx F, Cnockaert P, De Smedt J, Van Den Haute M, Vander Mijnsbrugge D. High prevalence of mental disorders in primary care. J Affect Disord. 2004 Jan;78(1):49-55. doi: 10.1016/s0165-0327(02)00219-7.</citation>
    <PMID>14672796</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iceland</investigator_affiliation>
    <investigator_full_name>Svala Sigurdardottir</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Mild to moderate Depression</keyword>
  <keyword>Mild to moderate Anxiety</keyword>
  <keyword>Mindfulness based cognitive therapy</keyword>
  <keyword>Primary care</keyword>
  <keyword>PHQ-9</keyword>
  <keyword>GAD-7</keyword>
  <keyword>Antidepressants</keyword>
  <keyword>Anxiolytica</keyword>
  <keyword>Subjective wellbeing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There is a plan to make IPD and related data dictionaries available to other researchers when requested. We will be willing to share the below mentioned IPD.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The IPD and additional data will be shared at the time when the summary data are published or otherwise made available and will be available for 5 years after the end of the study.</ipd_time_frame>
    <ipd_access_criteria>The study protocol, SAP, ICF, CSR and analytic code can be available for relevant researches, working on similar studies or researchers who want to reproduce the protocol and set up of the study as well as for doing a meta-analysis on similar studies. This must be done in the timeframe mentioned above. The group working on this project (the PhD students consult group) will review the requests and make shared decision on that and as well as decide how it will be shared.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03272516
org study id: UI-2017-MBCT.
nct id: NCT03272516
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is done to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) for
      primary care patients that have mild to moderate symptoms of depression and anxiety. Half of
      the study participants will receive treatment as usual (TAU), and the other half will receive
      TAU plus MBCT. The investigators will be comparing changes in symptoms of depression and
      anxiety between the groups, and hypothesize that the TAU plus MBCT group will have
      significantly lower symptoms of depression and anxiety compared to TAU group
      post-intervention
Patients that show mild to moderate symptoms of depression and anxiety are common in the
      primary care setting. These patients are often treated with antidepressant or anxiolytic
      medication instead of cognitive therapy, which is the first choice of treatment according to
      clinical guidelines in Iceland. Although these patients are often referred to cognitive
      therapy, there are long waiting lists for group therapy and personal therapy is expensive.
      MBCT has been shown to have good effects on people with recurrent depression and on patients
      suffering from anxiety. Therefore, the investigators main objective is to assess whether MBCT
      is effective in the primary care setting for patients with mild symptoms of anxiety and
      depression and compare its effect to TAU.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial, where patients are randomized to two groups. Group 1 receives treatment as usual, group 2 receives treatment as usual plus Mindfulness Based Cognitive Therapy (MBCT) for symptoms of mild to moderate depression or anxiety.
Our primary aim is to investigate whether MBCT added to TAU is more effective than TAU alone in reducing mild to moderate symptoms of depression and/or anxiety among primary care patients.
Our secondary aim is to investigate whether MBCT added to TAU is more effective than TAU alone in:
Increasing subjective wellbeing
Reducing antidepressant/anxiolytica use for primary care patients, with mild to moderate symptoms of depression and/or anxiety.
primary purpose: Health Services Research
masking: Single (Investigator)
masking description: The investigator will contact all participants in both groups via email or telephone to ask them to answer questionnaires.The investigator will not have information about which group which participant is. Participants will be contacted and invited to answer a questionnaire before, after, 6 and 18 months after 8 weeks of TAU and TAU plus MBCT.
measure: Symptoms of depression measured with the PHQ-9 questionnaire
time frame: up to 18 months
description: Comparing scores on the PHQ-9 before and after the intervention as well as, 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
measure: Symptoms of anxiety measured with the GAD-7 questionnaire
time frame: up to 18 months
description: Comparing scores on the GAD-7 before and after the intervention as well as 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
measure: Subjective well-being measured with the SWEMWBS questionnaire
time frame: up to 18 months
description: Comparing overall score on the SWEMWBS before and after the intervention as well as 6 and 18 months after the intervention for both the control group (TAU) and the intervention group (TAU plus MBCT)
measure: Change in use of antidepressants
time frame: up to 18 months
description: Self reported use of antidepressants in a questionnaire sent out by the study organization
measure: Change in use of anxiolytics
time frame: up to 18 months
description: Self reported use of antidepressants in a questionnaire sent out by the study organization
arm group label: Control group
arm group type: Active Comparator
description: This group receives treatment as usual (TAU) from his/hers physician. This treatment is different for each physician, but mainly consists of cognitive therapy, personal interviews or antidepressants or anxiolytics.
arm group label: Intervention group
arm group type: Experimental
description: Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol..
intervention type: Behavioral
intervention name: Mindfulness based cognitive therapy (MBCT)
description: Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol.
arm group label: Intervention group
intervention type: Other
intervention name: Treatment as usual (TAU)
description: Usual treatment prescribed by each physician, specifically interview therapy, cognitive therapy, antidepressants and/or anxiolytics as well as a mixture of all of the above.
arm group label: Control group
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: No
last name: Dóra G Gudmundsdóttir, PhD
role: Study Chair
affiliation: Directorate of Health, Iceland
facility: 
facility: 
country: Iceland
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PMID: 21802618
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PMID: 16717171
citation: Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
PMID: 16443717
citation: Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, Hayes R, Huijbers M, Ma H, Schweizer S, Segal Z, Speckens A, Teasdale JD, Van Heeringen K, Williams M, Byford S, Byng R, Dalgleish T. Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse: An Individual Patient Data Meta-analysis From Randomized Trials. JAMA Psychiatry. 2016 Jun 1;73(6):565-74. doi: 10.1001/jamapsychiatry.2016.0076.
PMID: 27119968
citation: Ansseau M, Dierick M, Buntinkx F, Cnockaert P, De Smedt J, Van Den Haute M, Vander Mijnsbrugge D. High prevalence of mental disorders in primary care. J Affect Disord. 2004 Jan;78(1):49-55. doi: 10.1016/s0165-0327(02)00219-7.
PMID: 14672796
responsible party type: Principal Investigator
investigator affiliation: University of Iceland
investigator full name: Svala Sigurdardottir
investigator title: Principal Investigator
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
sharing ipd: Yes
ipd description: There is a plan to make IPD and related data dictionaries available to other researchers when requested. We will be willing to share the below mentioned IPD.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The IPD and additional data will be shared at the time when the summary data are published or otherwise made available and will be available for 5 years after the end of the study.
ipd access criteria: The study protocol, SAP, ICF, CSR and analytic code can be available for relevant researches, working on similar studies or researchers who want to reproduce the protocol and set up of the study as well as for doing a meta-analysis on similar studies. This must be done in the timeframe mentioned above. The group working on this project (the PhD students consult group) will review the requests and make shared decision on that and as well as decide how it will be shared.