xml: <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/NCT05993507</url>
    </required_header>
    <id_info>
      <org_study_id>2023.214.IRB3.097</org_study_id>
      <nct_id>NCT05993507</nct_id>
    </id_info>
    <brief_title>Mental Health Outcomes of Earthquake Survivors in Türkiye</brief_title>
    <official_title>A Scalable Psychological Intervention to Improve Mental Health Outcomes of Earthquake Survivors in Türkiye: An Open Trial Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Koç University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Koç University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary aim of this open trial pilot study will be to test feasibility, acceptability,&#xD;
        and potential impact of Problem Management Plus (PM+), brief, scalable psychological&#xD;
        intervention developed by WHO, for earthquake survivors in Türkiye. Secondly, this study aims&#xD;
        to assess trial procedures in preparation for a future studies evaluating the effectiveness&#xD;
        of PM+ intervention with earthquake survivors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Considering the fact that around 16% of Turkey's population is affected by the February 6&#xD;
        earthquakes, reaching a higher number of people on time can be achieved through the&#xD;
        implementation of brief, scalable interventions addressing common mental health problems.&#xD;
        This will be the first study that investigate the individual PM+ among earthquake survivors&#xD;
        in Türkiye. Testing these interventions will provide evidence for further use in future&#xD;
        disasters.&#xD;
  &#xD;
        The study will assess changes in depression, anxiety, posttraumatic stress symptoms,&#xD;
        psychological distress, and psychosocial functioning scores before and after the&#xD;
        intervention. The hypothesis to be examined posits that participants will have significantly&#xD;
        lower depression, anxiety, posttraumatic stress, psychological distress and psychosocial&#xD;
        functioning scores at the post assessment compared to pre-assessment.&#xD;
  &#xD;
        This study will be designed as a single group pre-and post-test research. The sample will be&#xD;
        adult earthquake survivors in Türkiye. A partnership has been formed with Travma ve Afet Ruh&#xD;
        Sağlığı Çalışmaları Derneği (TARDE), a non-governmental organization working in the&#xD;
        earthquake-stricken regions. 30 psychologists of TARDE have been trained for PM+ for their&#xD;
        work with people who experienced the earthquake. The outcome measures will be assessed two&#xD;
        times: once before and once after PM+ will be conducted. After the baseline assessment, all&#xD;
        participants will receive the consecutive 5-session on individual PM+. The PM+ intervention&#xD;
        consists of five weekly sessions incorporating evidence-based behavioral strategies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change of the Patient Health Questionnaire-9 (PHQ-9) over time</measure>
      <time_frame>once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks</time_frame>
      <description>PHQ-9 is a 9 item questionnaire that measures the severity of depression symptoms. Items are scored as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day), providing a 0-27 severity score. Higher scores indicate more severe depressive symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of the Generalized Anxiety Disorder-7 (GAD-7) over time</measure>
      <time_frame>once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks</time_frame>
      <description>GAD-7 is a 7-item measure of general anxiety symptoms that measures anxiety symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day) providing a range between 0 and 21. Higher scores indicate higher levels of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time</measure>
      <time_frame>once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks</time_frame>
      <description>The PCL-5 is a 20-item questionnaire that assesses the symptoms of PTSD. Items are scored from 0 (not at all) to 4 (extremely) providing a range between 0 and 16. Higher scores indicate higher levels of PTSD symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of the Kessler Psychological Distress Scale (K-10) over time</measure>
      <time_frame>once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks</time_frame>
      <description>K-10 is a 10-item scale that assesses the psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) and ranges between 10 and 50. Higher scores indicate more severe psychological distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of the World Health OrganizationDisability Assessment Schedule (WHODAS 2.0) over time</measure>
      <time_frame>once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks</time_frame>
      <description>WHODAS is a 12-item scale that assesses ability to engage in daily activities. Each item is scored from 0 (none) to 4 (extreme) and ranges between 0 and 48. Higher scores indicate more daily dysfunctioning.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Mental Health Issue</condition>
    <arm_group>
      <arm_group_label>Problem Management Plus (PM+)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>As an open trial single group pre-post design, all participants in the study will receive PM+.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Problem Management Plus (PM+)</intervention_name>
      <description>Problem Management Plus (PM+) is a brief, scalable intervention that is developed by World Health Organization for communities exposed to adversity. PM+ consists of five weekly in-person sessions of 90 minutes. The intervention integrates four evidence-based behavioural strategies: arousal reduction using a slow breathing exercise (session 1), problem-solving (session 2), behavioural activation by re-engaging with pleasant and task-oriented activities (session 3) and accessing social support (session 4). Homework practice is scheduled following each session and discussed in the next session. Psychoeducation is delivered in session 1 and relapse prevention is discussed in session 5. Facilitators will receive weekly supervisions by PM+ supervisors.</description>
      <arm_group_label>Problem Management Plus (PM+)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being 18 years or above&#xD;
  &#xD;
            -  being experienced the earthquake&#xD;
  &#xD;
            -  reported elevated level of psychological distress indicated by a score of &gt;15 on&#xD;
               Kessler Psychological Distress Scale&#xD;
  &#xD;
            -  reported impaired daily functioning indicated by a score of &gt;16 on World Health&#xD;
               Organization Disability Assessment Scale&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  imminent suicide risk (assessed with the PM+ manual suicidal thoughts interview)&#xD;
  &#xD;
            -  severe mental disorders (e.g., psychotic disorders) or cognitive impairment (e.g.,&#xD;
               severe intellectual disability (assessed by the PM+ manual observation checklist)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ayşenur Coşkun Toker, MA</last_name>
      <role>Study Chair</role>
      <affiliation>Koç University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ceren Acartürk, Assoc. Prof.</last_name>
      <phone>+902123381043</phone>
      <email>cacarturk@ku.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Koc University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Sangraula M, Turner EL, Luitel NP, van 't Hof E, Shrestha P, Ghimire R, Bryant R, Marahatta K, van Ommeren M, Kohrt BA, Jordans MJD. Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. Epidemiol Psychiatr Sci. 2020 May 26;29:e130. doi: 10.1017/S2045796020000414.</citation>
      <PMID>32452336</PMID>
    </reference>
    <reference>
      <citation>Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.</citation>
      <PMID>26407793</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993507
  org study id: 2023.214.IRB3.097
  nct id: NCT05993507
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The primary aim of this open trial pilot study will be to test feasibility, acceptability,
        and potential impact of Problem Management Plus (PM+), brief, scalable psychological
        intervention developed by WHO, for earthquake survivors in Türkiye. Secondly, this study aims
        to assess trial procedures in preparation for a future studies evaluating the effectiveness
        of PM+ intervention with earthquake survivors.
  Considering the fact that around 16% of Turkey's population is affected by the February 6
        earthquakes, reaching a higher number of people on time can be achieved through the
        implementation of brief, scalable interventions addressing common mental health problems.
        This will be the first study that investigate the individual PM+ among earthquake survivors
        in Türkiye. Testing these interventions will provide evidence for further use in future
        disasters.
  
        The study will assess changes in depression, anxiety, posttraumatic stress symptoms,
        psychological distress, and psychosocial functioning scores before and after the
        intervention. The hypothesis to be examined posits that participants will have significantly
        lower depression, anxiety, posttraumatic stress, psychological distress and psychosocial
        functioning scores at the post assessment compared to pre-assessment.
  
        This study will be designed as a single group pre-and post-test research. The sample will be
        adult earthquake survivors in Türkiye. A partnership has been formed with Travma ve Afet Ruh
        Sağlığı Çalışmaları Derneği (TARDE), a non-governmental organization working in the
        earthquake-stricken regions. 30 psychologists of TARDE have been trained for PM+ for their
        work with people who experienced the earthquake. The outcome measures will be assessed two
        times: once before and once after PM+ will be conducted. After the baseline assessment, all
        participants will receive the consecutive 5-session on individual PM+. The PM+ intervention
        consists of five weekly sessions incorporating evidence-based behavioral strategies.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change of the Patient Health Questionnaire-9 (PHQ-9) over time
  time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
  description: PHQ-9 is a 9 item questionnaire that measures the severity of depression symptoms. Items are scored as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate more severe depressive symptoms.
  measure: Change of the Generalized Anxiety Disorder-7 (GAD-7) over time
  time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
  description: GAD-7 is a 7-item measure of general anxiety symptoms that measures anxiety symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day) providing a range between 0 and 21. Higher scores indicate higher levels of anxiety.
  measure: Change of the Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual-5 (DSM-5) (PCL-5) over time
  time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
  description: The PCL-5 is a 20-item questionnaire that assesses the symptoms of PTSD. Items are scored from 0 (not at all) to 4 (extremely) providing a range between 0 and 16. Higher scores indicate higher levels of PTSD symptoms.
  measure: Change of the Kessler Psychological Distress Scale (K-10) over time
  time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
  description: K-10 is a 10-item scale that assesses the psychological distress. Each item is scored from 1 (none of the time) to 5 (all of the time) and ranges between 10 and 50. Higher scores indicate more severe psychological distress.
  measure: Change of the World Health OrganizationDisability Assessment Schedule (WHODAS 2.0) over time
  time frame: once before (within a few days and no longer than one week after the pre-intervention) and one week after the last session of PM+ will be conducted; which is expected to last an average of 7 weeks
  description: WHODAS is a 12-item scale that assesses ability to engage in daily activities. Each item is scored from 0 (none) to 4 (extreme) and ranges between 0 and 48. Higher scores indicate more daily dysfunctioning.
  arm group label: Problem Management Plus (PM+)
  arm group type: Experimental
  description: As an open trial single group pre-post design, all participants in the study will receive PM+.
  intervention type: Behavioral
  intervention name: Problem Management Plus (PM+)
  description: Problem Management Plus (PM+) is a brief, scalable intervention that is developed by World Health Organization for communities exposed to adversity. PM+ consists of five weekly in-person sessions of 90 minutes. The intervention integrates four evidence-based behavioural strategies: arousal reduction using a slow breathing exercise (session 1), problem-solving (session 2), behavioural activation by re-engaging with pleasant and task-oriented activities (session 3) and accessing social support (session 4). Homework practice is scheduled following each session and discussed in the next session. Psychoeducation is delivered in session 1 and relapse prevention is discussed in session 5. Facilitators will receive weekly supervisions by PM+ supervisors.
  arm group label: Problem Management Plus (PM+)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ayşenur Coşkun Toker, MA
  role: Study Chair
  affiliation: Koç University
  last name: Ceren Acartürk, Assoc. Prof.
  phone: +902123381043
  email: cacarturk@ku.edu.tr
  facility: 
  country: Turkey
  citation: Sangraula M, Turner EL, Luitel NP, van 't Hof E, Shrestha P, Ghimire R, Bryant R, Marahatta K, van Ommeren M, Kohrt BA, Jordans MJD. Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal. Epidemiol Psychiatr Sci. 2020 May 26;29:e130. doi: 10.1017/S2045796020000414.
  PMID: 32452336
  citation: Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.
  PMID: 26407793
  responsible party type: Sponsor
  sharing ipd: No