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/NCT06026306</url>
    </required_header>
    <id_info>
      <org_study_id>2023.271.IRB3.125</org_study_id>
      <nct_id>NCT06026306</nct_id>
    </id_info>
    <brief_title>A Scalable Psychological Intervention for Earthquake Survivors in Türkiye: A Pilot Randomized Controlled Trial</brief_title>
    <official_title>A Pilot Randomized Controlled Trial of a Scalable Psychological Intervention for Enhancing Mental Health Outcomes Among Earthquake Survivors in Türkiye</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Koç University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Koç University</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 will be the first pilot randomized controlled trial (RCT) study that investigate the&#xD;
        potential effectiveness of individual PM+ among earthquake survivors residing in container&#xD;
        cities in Türkiye. The primary objective of this pilot study will be to test feasibility,&#xD;
        acceptability, and potential effectiveness of individual PM+ for Turkish earthquake&#xD;
        survivors, using RCT design which is considered the gold standard in research for evaluating&#xD;
        effectiveness of interventions. Secondly, this study aims to test trial procedures in&#xD;
        preparation for a future larger randomized controlled trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        On the 6th February, 2023, Türkiye experienced two consecutive earthquakes with magnitudes of&#xD;
        7.7 andd 7.6. As a consequence of such a disaster, the increasing prevalence of mental health&#xD;
        issues has resulted in increased need and demand for mental health and psychosocial support&#xD;
        (MHPSS) services in the country. In order to reach a higher number of people on time,&#xD;
        implementation of brief, scalable interventions addressing common mental health problems has&#xD;
        garnered significant importance. One such intervention is Problem Management Plus (PM+;&#xD;
        Dawson et al., 2015) that is developed by World Health Organization for communities that&#xD;
        experienced adversities. PM+ is a 5-session psychological intervention that aims to improve&#xD;
        common mental health problems by teaching participants evidence-based behavioral strategies&#xD;
        (i.e., stress management, problem solving, behavioral activation and strengthening social&#xD;
        support). Both the individual and group versions of PM+ were tested for feasibility,&#xD;
        acceptability, and effectiveness in various countries among different populations, including&#xD;
        the earthquake-affected communities in Nepal (Bryant et al., 2017; Rahmen et al., 2019;&#xD;
        Sangraula et al., 2020).&#xD;
  &#xD;
        This study will be the first to test the potential effectiveness of individual PM+ among&#xD;
        earthquake survivors in Türkiye. The study will be designed as a pilot randomized controlled&#xD;
        trial and the potential effectiveness of individual PM+ will be tested compared to&#xD;
        Enhanced-Care as Usual (E-CAU) control group. The study is planned to be conducted at&#xD;
        container cities in different earthquake regions (e.g., Koç Holding container cities in&#xD;
        Hatay, Adıyaman or Malatya). After the baseline assessment, eligible 60 participants will be&#xD;
        randomized to two arms: in either the PM+ (n=30) or only control group (E-CAU; n=30). If they&#xD;
        will be randomized into the PM+ condition, the facilitator will plan five consecutive&#xD;
        sessions (and one booster session) with the participants. The first session will take place&#xD;
        no longer than one week after the pre-intervention assessment. The post-intervention&#xD;
        assessment through the same measures used in the pretest will take place within 1 week after&#xD;
        completion of the fifth session. Another post-intervention assessment (follow-up assessment)&#xD;
        will be conducted after completion of the booster session. All study participants including&#xD;
        drop-outs will be invited to all outcome assessments. After completion of the follow-up&#xD;
        assessment, those in the E-CAU condition will be offered with PM+. The primary outcome&#xD;
        measure will be depression and anxiety, posttraumatic stress, psychological distress and&#xD;
        psychosocial functioning will be included as secondary outcome measures.&#xD;
  &#xD;
        In order to assess feasibility and acceptability of these interventions, and the possibility&#xD;
        of scaling up as well, we will assess the recruitment and consent rates, the percentages of&#xD;
        attendance of sessions, the protocol adherence, drop-out rates and qualitative assessments&#xD;
        from the process evaluation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>
      <masking_description>Participants will not be blinded to their study arm because of the nature of the intervention, but outcome assessors will be blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change of the Patient Health Questionnaire-9 (PHQ-9) over time</measure>
      <time_frame>change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks</time_frame>
      <description>PHQ-9 is a 9-item questionnaire that aims to measure the depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day) providing a range between 0 and 27. 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>change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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>change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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>change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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 Organization Disability Assessment Schedule (WHODAS 2.0) over time</measure>
      <time_frame>change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Psychological Distress</condition>
    <condition>Impaired Social Functioning</condition>
    <condition>Depressive Symptoms</condition>
    <arm_group>
      <arm_group_label>Problem Management Plus (PM+)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group will receive a 5-session individual PM+.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Enhanced Care as Usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control (enhanced care as usual) group will receive the information about freely available psychological support options. E-CAU ranges from standard community care which may include any existing mental health support services available to earthquake survivors in container cities. The participants will be given flyers which include information about the services provided by the government and by non-governmental organizations. After completion of the post and follow-up assessment of experimental group, those in the E-CAU condition will be offered with PM+.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Problem Management Plus (PM+)</intervention_name>
      <description>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</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 Kahramanmaraş earthquake&#xD;
  &#xD;
            -  Elevated level of psychological distress indicated by having a score of 15 or above on&#xD;
               Kessler Psychological Distress Scale (K10)&#xD;
  &#xD;
            -  Impaired daily functioning indicated by having a score of 16 or above on WHO&#xD;
               Disability Assessment Schedule (WHODAS)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  imminent suicide risk (assessed with the PM+ manual suicidal thoughts interview),&#xD;
  &#xD;
            -  indications of severe mental disorders (e.g., psychotic disorders) or cognitive&#xD;
               impairment (e.g., severe intellectual disability; assessed by the PM+ manual&#xD;
               observation checklist),&#xD;
  &#xD;
            -  ongoing treatment in specialized mental health care.&#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, PhD student</last_name>
      <role>Study Chair</role>
      <affiliation>Koç University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ceren Acartürk, Assoc. Prof</last_name>
      <phone>+90 212 338 1043</phone>
      <phone_ext>1043</phone_ext>
      <email>cacarturk@ku.edu.tr</email>
    </overall_contact>
    <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>
    <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>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <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/NCT06026306
  org study id: 2023.271.IRB3.125
  nct id: NCT06026306
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This will be the first pilot randomized controlled trial (RCT) study that investigate the
        potential effectiveness of individual PM+ among earthquake survivors residing in container
        cities in Türkiye. The primary objective of this pilot study will be to test feasibility,
        acceptability, and potential effectiveness of individual PM+ for Turkish earthquake
        survivors, using RCT design which is considered the gold standard in research for evaluating
        effectiveness of interventions. Secondly, this study aims to test trial procedures in
        preparation for a future larger randomized controlled trial.
  On the 6th February, 2023, Türkiye experienced two consecutive earthquakes with magnitudes of
        7.7 andd 7.6. As a consequence of such a disaster, the increasing prevalence of mental health
        issues has resulted in increased need and demand for mental health and psychosocial support
        (MHPSS) services in the country. In order to reach a higher number of people on time,
        implementation of brief, scalable interventions addressing common mental health problems has
        garnered significant importance. One such intervention is Problem Management Plus (PM+;
        Dawson et al., 2015) that is developed by World Health Organization for communities that
        experienced adversities. PM+ is a 5-session psychological intervention that aims to improve
        common mental health problems by teaching participants evidence-based behavioral strategies
        (i.e., stress management, problem solving, behavioral activation and strengthening social
        support). Both the individual and group versions of PM+ were tested for feasibility,
        acceptability, and effectiveness in various countries among different populations, including
        the earthquake-affected communities in Nepal (Bryant et al., 2017; Rahmen et al., 2019;
        Sangraula et al., 2020).
  
        This study will be the first to test the potential effectiveness of individual PM+ among
        earthquake survivors in Türkiye. The study will be designed as a pilot randomized controlled
        trial and the potential effectiveness of individual PM+ will be tested compared to
        Enhanced-Care as Usual (E-CAU) control group. The study is planned to be conducted at
        container cities in different earthquake regions (e.g., Koç Holding container cities in
        Hatay, Adıyaman or Malatya). After the baseline assessment, eligible 60 participants will be
        randomized to two arms: in either the PM+ (n=30) or only control group (E-CAU; n=30). If they
        will be randomized into the PM+ condition, the facilitator will plan five consecutive
        sessions (and one booster session) with the participants. The first session will take place
        no longer than one week after the pre-intervention assessment. The post-intervention
        assessment through the same measures used in the pretest will take place within 1 week after
        completion of the fifth session. Another post-intervention assessment (follow-up assessment)
        will be conducted after completion of the booster session. All study participants including
        drop-outs will be invited to all outcome assessments. After completion of the follow-up
        assessment, those in the E-CAU condition will be offered with PM+. The primary outcome
        measure will be depression and anxiety, posttraumatic stress, psychological distress and
        psychosocial functioning will be included as secondary outcome measures.
  
        In order to assess feasibility and acceptability of these interventions, and the possibility
        of scaling up as well, we will assess the recruitment and consent rates, the percentages of
        attendance of sessions, the protocol adherence, drop-out rates and qualitative assessments
        from the process evaluation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Participants will not be blinded to their study arm because of the nature of the intervention, but outcome assessors will be blinded.
  measure: Change of the Patient Health Questionnaire-9 (PHQ-9) over time
  time frame: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); which is expected to last an average of 7 weeks
  description: PHQ-9 is a 9-item questionnaire that aims to measure the depressive symptoms. Each item is scored from 0 (not at all) to 3 (nearly every day) providing a range between 0 and 27. Higher scores indicate more severe depressive symptoms.
  measure: Change of the Generalized Anxiety Disorder-7 (GAD-7) over time
  time frame: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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 Organization Disability Assessment Schedule (WHODAS 2.0) over time
  time frame: change from baseline (one week before the first session of PM+) to post assessment (one week after the last session of PM+); 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: The experimental group will receive a 5-session individual PM+.
  arm group label: Enhanced Care as Usual
  arm group type: No Intervention
  description: The control (enhanced care as usual) group will receive the information about freely available psychological support options. E-CAU ranges from standard community care which may include any existing mental health support services available to earthquake survivors in container cities. The participants will be given flyers which include information about the services provided by the government and by non-governmental organizations. After completion of the post and follow-up assessment of experimental group, those in the E-CAU condition will be offered with PM+.
  intervention type: Behavioral
  intervention name: Problem Management Plus (PM+)
  description: 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
  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, PhD student
  role: Study Chair
  affiliation: Koç University
  last name: Ceren Acartürk, Assoc. Prof
  phone: +90 212 338 1043
  phone ext: 1043
  email: cacarturk@ku.edu.tr
  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
  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
  responsible party type: Sponsor
  mesh term: Depression
  sharing ipd: No