<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/NCT03830008</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC-2017-01175</org_study_id>
    <nct_id>NCT03830008</nct_id>
  </id_info>
  <brief_title>Scaling-up Psychological Interventions With Syrian Refugees in Switzerland</brief_title>
  <acronym>STRENGTHS_CH</acronym>
  <official_title>Scaling-up Psychological Interventions With Syrian Refugees in Switzerland</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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 current refugee crisis across the Middle East and Europe has large effects on individual&#xD;
      refugees' psychological well-being, as well as on the healthcare systems of countries hosting&#xD;
      refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the&#xD;
      specific psychological treatment due to a lack of specialists. To address this problem the&#xD;
      WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity&#xD;
      psychological intervention, delivered by paraprofessionals, that addresses common mental&#xD;
      disorders in people in communities affected by adversity. The feasibility of PM+ has never&#xD;
      been examined in Switzerland before, this is the aim of the current pilot study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent crises in the Middle East, most notably in Syria, have resulted in an unprecedented&#xD;
      increase in the worldwide number of refugees and asylum seekers. Switzerland (CH) is strongly&#xD;
      affected by this crisis too. Eight percent of asylum requests in 2016 were made by people&#xD;
      from Syria (2015: 12 %). More than 7'000 asylum seekers from Syria entered CH over the last&#xD;
      two years. Due to the ongoing war in this region, it is unlikely that this kind of migration&#xD;
      and flight will stop. Notably, 50% of the refugee population are children and adolescents.&#xD;
&#xD;
      Refugees have typically been exposed to multiple stressors related to war and displacement&#xD;
      including loss of family members, destruction of homes and livelihoods and human rights&#xD;
      violations such as sexual violence or torture. They have often undertaken a risky and&#xD;
      stressful flight leaving their homes for an unknown future. Accordingly, studies consistently&#xD;
      show that refugees are at considerable risk of developing common mental disorders, including&#xD;
      depression, anxiety, posttraumatic stress disorder (PTSD) and related somatic health&#xD;
      symptoms. Recent WHO projections suggest that approximately 15-20% of Syrian refugees will&#xD;
      develop some type of mental health problem and therefore represent an enormous public mental&#xD;
      health challenge.&#xD;
&#xD;
      According to the UNHCR, 86% of all displaced persons remain in conflict or neighboring&#xD;
      countries where appropriate health care is mostly not available. But also Western health&#xD;
      systems are often unable to appropriately cover the needs of this particularly vulnerable&#xD;
      population regarding prevention and treatment of mental health problems. As a response to&#xD;
      this situation, the WHO developed the low-intensity Problem Management Plus (PM+) programs, a&#xD;
      new generation of shorter, less expensive and trans-diagnostic (i.e., not specifically aimed&#xD;
      at treating a certain mental disorder) programs to reduce common mental health symptoms and&#xD;
      improve psychosocial functioning. PM+ is based on the WHO treatment guidelines for conditions&#xD;
      related to stress. PM+ is a 5-sessions intervention aimed at reducing symptoms of depression,&#xD;
      anxiety, PTSD, and related conditions, is delivered by trained non-specialized workers or lay&#xD;
      people, and is available in individual and group delivery formats for both children and&#xD;
      adults. It comprises evidence-based techniques of (a) problem solving, (b) stress management,&#xD;
      (c) behavioral activation, and (d) accessing social support. PM+ has been successfully&#xD;
      implemented in Kenya and Pakistan.&#xD;
&#xD;
      The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study aims at evaluating the&#xD;
      effectiveness and implementation of PM+ with Syrian refugees in different settings in low-&#xD;
      and high-resource countries. The study consortium includes international experts in the&#xD;
      domains of trauma and public mental health as well as representatives of WHO and UNHCR. The&#xD;
      Zürich study site has been consigned to examine PM+ with adult refugees in an individual&#xD;
      treatment setting in Switzerland. At the same time, similar studies in other countries will&#xD;
      be undertaken. Despite the objective of these studies to implement and evaluate the&#xD;
      effectiveness of PM+ in refugees, each research institution acts independently. Moreover, the&#xD;
      other studies will be completed in different treatment settings - i.e., in children and&#xD;
      adolescents (Lebanon), in groups (Turkey and Netherlands), and internet-delivered PM+&#xD;
      (Germany and Egypt).&#xD;
&#xD;
      To date, the feasibility of PM+ has not been investigated in a highly industrialized country,&#xD;
      such as Switzerland.&#xD;
&#xD;
      In the present study, the investigators will evaluate the feasibility of PM+ in Syrian&#xD;
      refugees in Switzerland.&#xD;
&#xD;
      This research entails single-blind randomized controlled trial.&#xD;
&#xD;
      The amendment was secured by December 2018. Trainers, assessors, supervisors and helpers are&#xD;
      already identified, recruited an trained.&#xD;
&#xD;
      After the approval, the first participants will be identified, invited to screening and if&#xD;
      they fulfill the criteria they will be invited to participate in the pilot study. The pilot&#xD;
      study will end by the end of 2019. After the pilot study the results will be evaluated,&#xD;
      analyzed and integrated in the planning of the definitive randomized controlled trial (RCT)&#xD;
      (next study, not the part of current registration).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">March 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 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>
    <intervention_model_description>The exploratory RCT will inform us about the feasibility, safety, and delivery of the intervention; this will identify issues around its training, supervision and outcome measures.&#xD;
After the baseline assessment, sixty participants (N = 60) will be involved in the exploratory RCT (assigned to either the PM+ intervention (n=30) or the ETAU control condition (n=30)). The investigators intend to deliver the intervention to 30 participants, allowing us to test the feasibility and acceptability of the intervention in the proposed setting and inform the sample size for a future definitive trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All instruments and questions will be administered using tablets by trained research staff blind to the allocation status of the participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Verification procedure to the measurement in psychological distress at baseline assessment</measure>
    <time_frame>baseline assessment (before PM+)</time_frame>
    <description>measured by the Hopkins Symptom Checklist (HSCL-25)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU</measure>
    <time_frame>post-assessment baseline (after PM+/ETAU)</time_frame>
    <description>measured by the Hopkins Symptom Checklist (HSCL-25)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Verification procedure to the measurement in psychological distress 3 months after PM+ intervention or ETAU</measure>
    <time_frame>3-months follow-up (after PM+/ETAU)</time_frame>
    <description>measured by the Hopkins Symptom Checklist (HSCL-25)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment</measure>
    <time_frame>baseline assessment (before PM+)</time_frame>
    <description>measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verification procedure to the measurement of symptoms of posttraumatic stress disorder after PM+ intervention or ETAU</measure>
    <time_frame>post-assessment baseline (after PM+/ETAU)</time_frame>
    <description>measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verification procedure to the measurement of symptoms of posttraumatic stress disorder 3 months after PM+ intervention or ETAU</measure>
    <time_frame>3-months follow-up (after PM+/ETAU)</time_frame>
    <description>measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verification procedure to the measurement of functional disability at screening</measure>
    <time_frame>screening (before PM+)</time_frame>
    <description>assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verification procedure to the measurement of functional disability after PM+ intervention or ETAU</measure>
    <time_frame>post-assessment baseline (after PM+/ETAU)</time_frame>
    <description>assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verification procedure to the measurement of functional disability 3 months after PM+ intervention or ETAU</measure>
    <time_frame>3-months follow-up (after PM+/ETAU)</time_frame>
    <description>assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PM+ by the number of dropouts</measure>
    <time_frame>screening (before PM+)</time_frame>
    <description>Monitoring of the dropouts by number of patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PM+ by the number of dropouts</measure>
    <time_frame>baseline assessment (before PM+)</time_frame>
    <description>Monitoring of the dropouts by number of patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PM+ by the number of dropouts</measure>
    <time_frame>post-assessment baseline (after PM+/ETAU)</time_frame>
    <description>Monitoring of the dropouts by number of patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PM+ by the number of dropouts</measure>
    <time_frame>3-months follow-up (after PM+/ETAU)</time_frame>
    <description>Monitoring of the dropouts by number of patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments</measure>
    <time_frame>screening (before PM+)</time_frame>
    <description>Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments</measure>
    <time_frame>baseline assessment (before PM+)</time_frame>
    <description>Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments</measure>
    <time_frame>post-assessment baseline (after PM+/ETAU)</time_frame>
    <description>Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments</measure>
    <time_frame>3-months follow-up (after PM+/ETAU)</time_frame>
    <description>Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Verification procedure to the measurement of change in response to therapy at baseline</measure>
    <time_frame>baseline assessment (before PM+)</time_frame>
    <description>patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from &quot;severely affected&quot; to &quot;not at all affected&quot;); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.]</description>
  </other_outcome>
  <other_outcome>
    <measure>Verification procedure to the measurement of change in response to therapy at post-assessment</measure>
    <time_frame>post-assessment baseline (after PM+/ETAU)</time_frame>
    <description>patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from &quot;severely affected&quot; to &quot;not at all affected&quot;); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.]</description>
  </other_outcome>
  <other_outcome>
    <measure>Verification procedure to the measurement of change in response to therapy 3 months after</measure>
    <time_frame>3-months follow-up (after PM+/ETAU)</time_frame>
    <description>patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from &quot;severely affected&quot; to &quot;not at all affected&quot;); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.]</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-migration stressors at baseline</measure>
    <time_frame>baseline assessment (before PM+)</time_frame>
    <description>will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-migration stressors at post-assessment</measure>
    <time_frame>post-assessment baseline (after PM+/ETAU)</time_frame>
    <description>will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-migration stressors 3 months after</measure>
    <time_frame>3-months follow-up (after PM+/ETAU)</time_frame>
    <description>will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)</description>
  </other_outcome>
  <other_outcome>
    <measure>Previous exposure to traumatic events</measure>
    <time_frame>baseline</time_frame>
    <description>assessed using the Traumatic Events (TE) - a combination of two standardized questionnaires, namely the Life Events Checklist (LEC) (Weathers et al., 2013) and the Harvard Trauma Questionnaire (HTQ) (Mollica et al., 1992). HTQ consists of 3 sections with 48 questions. LEC consists of 17 question. Single questions from HTQ (Section 1) and LEC are summarized to the sequence of 27 questions (about experienced trauma or adversities with yes/no answer format). The number of positive answers is the outcome value.</description>
  </other_outcome>
  <other_outcome>
    <measure>Access to Health Care Services (AHCS)</measure>
    <time_frame>baseline assessment (before PM+)</time_frame>
    <description>The set of question regarding previous contact with the mental health care services and the previous experiences regarding the utilization of any forms of mental support</description>
  </other_outcome>
  <other_outcome>
    <measure>Medical service utilization of people with mental disorders at baseline</measure>
    <time_frame>baseline assessment (before PM+)</time_frame>
    <description>accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research</description>
  </other_outcome>
  <other_outcome>
    <measure>Medical service utilization of people with mental disorders at post-assessment</measure>
    <time_frame>post-assessment baseline (after PM+/ETAU)</time_frame>
    <description>accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research</description>
  </other_outcome>
  <other_outcome>
    <measure>Medical service utilization of people with mental disorders at post-assessment 3 months after</measure>
    <time_frame>3-months follow-up (after PM+/ETAU)</time_frame>
    <description>accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Distress</condition>
  <condition>PTSD</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Trauma</condition>
  <condition>Functional Disabilities</condition>
  <condition>Common Mental Health Problems</condition>
  <arm_group>
    <arm_group_label>Enhanced Treatment As Usual (ETAU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive enhanced treatment as usual (ETAU). ETAU means that the research team will advise the participants to contact their doctor in case of physical or mental health problems. Moreover, the research team will hand over the list with the general practitioners (GP) in the neighborhood of the participant and the written information (official booklet) about the operating of the Swiss health care system. Adequate treatment will be provided by this physician, usually, a general practitioner who acts as a gate-keeper (an asylum seeker or refugee has to go first to his/her assigned GP in order to get access to the health care system).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Problem Management Plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PM+ is a new, brief, psychological intervention program based on Cognitive Behaviour Therapy (CBT) techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem Management Plus</intervention_name>
    <description>PM+ is a new, brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines.</description>
    <arm_group_label>Problem Management Plus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female Syrian refugees or asylum seekers who entered Switzerland after the&#xD;
             beginning of Syrian Civil War in March 2011&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Arabic-speaking&#xD;
&#xD;
          -  Signed Informed Consent after being informed&#xD;
&#xD;
          -  Increased psychological distress (K10 &gt; 15)&#xD;
&#xD;
          -  Reduced psychological functioning (WHODAS 2.0 &gt; 16)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to follow the procedures of the study&#xD;
&#xD;
          -  Previous enrolment into the current study&#xD;
&#xD;
          -  Previous or currently enrolment of a family member into the current study&#xD;
&#xD;
          -  Participants under tutelage&#xD;
&#xD;
          -  Acute or severe psychiatric (e.g. schizophrenia) or neurological illness (e.g.&#xD;
             dementia)&#xD;
&#xD;
          -  Imminent suicide risk&#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_official>
    <last_name>Naser Morina, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich / University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <state>ZH</state>
        <zip>8006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Sijbrandij M, Acarturk C, Bird M, Bryant RA, Burchert S, Carswell K, de Jong J, Dinesen C, Dawson KS, El Chammay R, van Ittersum L, Jordans M, Knaevelsrud C, McDaid D, Miller K, Morina N, Park AL, Roberts B, van Son Y, Sondorp E, Pfaltz MC, Ruttenberg L, Schick M, Schnyder U, van Ommeren M, Ventevogel P, Weissbecker I, Weitz E, Wiedemann N, Whitney C, Cuijpers P. Strengthening mental health care systems for Syrian refugees in Europe and the Middle East: integrating scalable psychological interventions in eight countries. Eur J Psychotraumatol. 2017 Nov 7;8(sup2):1388102. doi: 10.1080/20008198.2017.1388102. eCollection 2017.</citation>
    <PMID>29163867</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>
  <reference>
    <citation>Hassan, G., Kirmayer, L. J., Mekki-Berrada, A., Quosh, C., el Chammay, R., Deville-Stoetzel, J., . . . Coutts, A. (2015). Culture, context and the mental health and psychosocial wellbeing of Syrians: a review for mental health and psychosocial support staff working with Syrians affected by armed conflict. Geneva: UNHCR.</citation>
  </reference>
  <reference>
    <citation>Guidelines for the Management of Conditions Specifically Related to Stress. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK159725/</citation>
    <PMID>24049868</PMID>
  </reference>
  <reference>
    <citation>Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. No abstract available.</citation>
    <PMID>27265713</PMID>
  </reference>
  <reference>
    <citation>Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M. Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA. 2009 Aug 5;302(5):537-49. doi: 10.1001/jama.2009.1132.</citation>
    <PMID>19654388</PMID>
  </reference>
  <reference>
    <citation>Dua T, Barbui C, Clark N, Fleischmann A, Poznyak V, van Ommeren M, Yasamy MT, Ayuso-Mateos JL, Birbeck GL, Drummond C, Freeman M, Giannakopoulos P, Levav I, Obot IS, Omigbodun O, Patel V, Phillips M, Prince M, Rahimi-Movaghar A, Rahman A, Sander JW, Saunders JB, Servili C, Rangaswamy T, Unutzer J, Ventevogel P, Vijayakumar L, Thornicroft G, Saxena S. Evidence-based guidelines for mental, neurological, and substance use disorders in low- and middle-income countries: summary of WHO recommendations. PLoS Med. 2011 Nov;8(11):e1001122. doi: 10.1371/journal.pmed.1001122. Epub 2011 Nov 15.</citation>
    <PMID>22110406</PMID>
  </reference>
  <reference>
    <citation>Tol WA, Barbui C, van Ommeren M. Management of acute stress, PTSD, and bereavement: WHO recommendations. JAMA. 2013 Aug 7;310(5):477-8. doi: 10.1001/jama.2013.166723. No abstract available.</citation>
    <PMID>23925613</PMID>
  </reference>
  <reference>
    <citation>mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP): Version 2.0. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK390828/</citation>
    <PMID>27786430</PMID>
  </reference>
  <reference>
    <citation>Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P., Marx, B., &amp; Schnurr, P. (2013). The ptsd checklist for dsm-5 (pcl-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.</citation>
  </reference>
  <reference>
    <citation>Mollica RF, Caspi-Yavin Y, Bollini P, Truong T, Tor S, Lavelle J. The Harvard Trauma Questionnaire. Validating a cross-cultural instrument for measuring torture, trauma, and posttraumatic stress disorder in Indochinese refugees. J Nerv Ment Dis. 1992 Feb;180(2):111-6.</citation>
    <PMID>1737972</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Problem Management Plus</keyword>
  <keyword>Distress</keyword>
  <keyword>Mental Health Care</keyword>
  <keyword>Low-intensity</keyword>
  <keyword>Refugees</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03830008
org study id: BASEC-2017-01175
nct id: NCT03830008
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The current refugee crisis across the Middle East and Europe has large effects on individual
      refugees' psychological well-being, as well as on the healthcare systems of countries hosting
      refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the
      specific psychological treatment due to a lack of specialists. To address this problem the
      WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity
      psychological intervention, delivered by paraprofessionals, that addresses common mental
      disorders in people in communities affected by adversity. The feasibility of PM+ has never
      been examined in Switzerland before, this is the aim of the current pilot study.
Recent crises in the Middle East, most notably in Syria, have resulted in an unprecedented
      increase in the worldwide number of refugees and asylum seekers. Switzerland (CH) is strongly
      affected by this crisis too. Eight percent of asylum requests in 2016 were made by people
      from Syria (2015: 12 %). More than 7'000 asylum seekers from Syria entered CH over the last
      two years. Due to the ongoing war in this region, it is unlikely that this kind of migration
      and flight will stop. Notably, 50% of the refugee population are children and adolescents.

      Refugees have typically been exposed to multiple stressors related to war and displacement
      including loss of family members, destruction of homes and livelihoods and human rights
      violations such as sexual violence or torture. They have often undertaken a risky and
      stressful flight leaving their homes for an unknown future. Accordingly, studies consistently
      show that refugees are at considerable risk of developing common mental disorders, including
      depression, anxiety, posttraumatic stress disorder (PTSD) and related somatic health
      symptoms. Recent WHO projections suggest that approximately 15-20% of Syrian refugees will
      develop some type of mental health problem and therefore represent an enormous public mental
      health challenge.

      According to the UNHCR, 86% of all displaced persons remain in conflict or neighboring
      countries where appropriate health care is mostly not available. But also Western health
      systems are often unable to appropriately cover the needs of this particularly vulnerable
      population regarding prevention and treatment of mental health problems. As a response to
      this situation, the WHO developed the low-intensity Problem Management Plus (PM+) programs, a
      new generation of shorter, less expensive and trans-diagnostic (i.e., not specifically aimed
      at treating a certain mental disorder) programs to reduce common mental health symptoms and
      improve psychosocial functioning. PM+ is based on the WHO treatment guidelines for conditions
      related to stress. PM+ is a 5-sessions intervention aimed at reducing symptoms of depression,
      anxiety, PTSD, and related conditions, is delivered by trained non-specialized workers or lay
      people, and is available in individual and group delivery formats for both children and
      adults. It comprises evidence-based techniques of (a) problem solving, (b) stress management,
      (c) behavioral activation, and (d) accessing social support. PM+ has been successfully
      implemented in Kenya and Pakistan.

      The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study aims at evaluating the
      effectiveness and implementation of PM+ with Syrian refugees in different settings in low-
      and high-resource countries. The study consortium includes international experts in the
      domains of trauma and public mental health as well as representatives of WHO and UNHCR. The
      Zürich study site has been consigned to examine PM+ with adult refugees in an individual
      treatment setting in Switzerland. At the same time, similar studies in other countries will
      be undertaken. Despite the objective of these studies to implement and evaluate the
      effectiveness of PM+ in refugees, each research institution acts independently. Moreover, the
      other studies will be completed in different treatment settings - i.e., in children and
      adolescents (Lebanon), in groups (Turkey and Netherlands), and internet-delivered PM+
      (Germany and Egypt).

      To date, the feasibility of PM+ has not been investigated in a highly industrialized country,
      such as Switzerland.

      In the present study, the investigators will evaluate the feasibility of PM+ in Syrian
      refugees in Switzerland.

      This research entails single-blind randomized controlled trial.

      The amendment was secured by December 2018. Trainers, assessors, supervisors and helpers are
      already identified, recruited an trained.

      After the approval, the first participants will be identified, invited to screening and if
      they fulfill the criteria they will be invited to participate in the pilot study. The pilot
      study will end by the end of 2019. After the pilot study the results will be evaluated,
      analyzed and integrated in the planning of the definitive randomized controlled trial (RCT)
      (next study, not the part of current registration).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The exploratory RCT will inform us about the feasibility, safety, and delivery of the intervention; this will identify issues around its training, supervision and outcome measures.
After the baseline assessment, sixty participants (N = 60) will be involved in the exploratory RCT (assigned to either the PM+ intervention (n=30) or the ETAU control condition (n=30)). The investigators intend to deliver the intervention to 30 participants, allowing us to test the feasibility and acceptability of the intervention in the proposed setting and inform the sample size for a future definitive trial.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: All instruments and questions will be administered using tablets by trained research staff blind to the allocation status of the participants.
measure: Verification procedure to the measurement in psychological distress at baseline assessment
time frame: baseline assessment (before PM+)
description: measured by the Hopkins Symptom Checklist (HSCL-25)
measure: Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU
time frame: post-assessment baseline (after PM+/ETAU)
description: measured by the Hopkins Symptom Checklist (HSCL-25)
measure: Verification procedure to the measurement in psychological distress 3 months after PM+ intervention or ETAU
time frame: 3-months follow-up (after PM+/ETAU)
description: measured by the Hopkins Symptom Checklist (HSCL-25)
measure: Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment
time frame: baseline assessment (before PM+)
description: measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
measure: Verification procedure to the measurement of symptoms of posttraumatic stress disorder after PM+ intervention or ETAU
time frame: post-assessment baseline (after PM+/ETAU)
description: measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
measure: Verification procedure to the measurement of symptoms of posttraumatic stress disorder 3 months after PM+ intervention or ETAU
time frame: 3-months follow-up (after PM+/ETAU)
description: measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)
measure: Verification procedure to the measurement of functional disability at screening
time frame: screening (before PM+)
description: assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
measure: Verification procedure to the measurement of functional disability after PM+ intervention or ETAU
time frame: post-assessment baseline (after PM+/ETAU)
description: assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
measure: Verification procedure to the measurement of functional disability 3 months after PM+ intervention or ETAU
time frame: 3-months follow-up (after PM+/ETAU)
description: assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0)
measure: Feasibility of PM+ by the number of dropouts
time frame: screening (before PM+)
description: Monitoring of the dropouts by number of patients
measure: Feasibility of PM+ by the number of dropouts
time frame: baseline assessment (before PM+)
description: Monitoring of the dropouts by number of patients
measure: Feasibility of PM+ by the number of dropouts
time frame: post-assessment baseline (after PM+/ETAU)
description: Monitoring of the dropouts by number of patients
measure: Feasibility of PM+ by the number of dropouts
time frame: 3-months follow-up (after PM+/ETAU)
description: Monitoring of the dropouts by number of patients
measure: Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
time frame: screening (before PM+)
description: Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
measure: Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
time frame: baseline assessment (before PM+)
description: Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
measure: Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
time frame: post-assessment baseline (after PM+/ETAU)
description: Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
measure: Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
time frame: 3-months follow-up (after PM+/ETAU)
description: Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback)
measure: Verification procedure to the measurement of change in response to therapy at baseline
time frame: baseline assessment (before PM+)
description: patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.]
measure: Verification procedure to the measurement of change in response to therapy at post-assessment
time frame: post-assessment baseline (after PM+/ETAU)
description: patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.]
measure: Verification procedure to the measurement of change in response to therapy 3 months after
time frame: 3-months follow-up (after PM+/ETAU)
description: patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.]
measure: Post-migration stressors at baseline
time frame: baseline assessment (before PM+)
description: will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)
measure: Post-migration stressors at post-assessment
time frame: post-assessment baseline (after PM+/ETAU)
description: will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)
measure: Post-migration stressors 3 months after
time frame: 3-months follow-up (after PM+/ETAU)
description: will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC)
measure: Previous exposure to traumatic events
time frame: baseline
description: assessed using the Traumatic Events (TE) - a combination of two standardized questionnaires, namely the Life Events Checklist (LEC) (Weathers et al., 2013) and the Harvard Trauma Questionnaire (HTQ) (Mollica et al., 1992). HTQ consists of 3 sections with 48 questions. LEC consists of 17 question. Single questions from HTQ (Section 1) and LEC are summarized to the sequence of 27 questions (about experienced trauma or adversities with yes/no answer format). The number of positive answers is the outcome value.
measure: Access to Health Care Services (AHCS)
time frame: baseline assessment (before PM+)
description: The set of question regarding previous contact with the mental health care services and the previous experiences regarding the utilization of any forms of mental support
measure: Medical service utilization of people with mental disorders at baseline
time frame: baseline assessment (before PM+)
description: accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research
measure: Medical service utilization of people with mental disorders at post-assessment
time frame: post-assessment baseline (after PM+/ETAU)
description: accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research
measure: Medical service utilization of people with mental disorders at post-assessment 3 months after
time frame: 3-months follow-up (after PM+/ETAU)
description: accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research
arm group label: Enhanced Treatment As Usual (ETAU)
arm group type: No Intervention
description: The control group will receive enhanced treatment as usual (ETAU). ETAU means that the research team will advise the participants to contact their doctor in case of physical or mental health problems. Moreover, the research team will hand over the list with the general practitioners (GP) in the neighborhood of the participant and the written information (official booklet) about the operating of the Swiss health care system. Adequate treatment will be provided by this physician, usually, a general practitioner who acts as a gate-keeper (an asylum seeker or refugee has to go first to his/her assigned GP in order to get access to the health care system).
arm group label: Problem Management Plus
arm group type: Experimental
description: PM+ is a new, brief, psychological intervention program based on Cognitive Behaviour Therapy (CBT) techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines.
intervention type: Behavioral
intervention name: Problem Management Plus
description: PM+ is a new, brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines.
arm group label: Problem Management Plus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naser Morina, PhD
role: Principal Investigator
affiliation: University Hospital Zurich / University of Zurich
facility: 
country: Switzerland
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PMID: 29163867
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: Hassan, G., Kirmayer, L. J., Mekki-Berrada, A., Quosh, C., el Chammay, R., Deville-Stoetzel, J., . . . Coutts, A. (2015). Culture, context and the mental health and psychosocial wellbeing of Syrians: a review for mental health and psychosocial support staff working with Syrians affected by armed conflict. Geneva: UNHCR.
citation: Guidelines for the Management of Conditions Specifically Related to Stress. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK159725/
PMID: 24049868
citation: Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. No abstract available.
PMID: 27265713
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PMID: 19654388
citation: Dua T, Barbui C, Clark N, Fleischmann A, Poznyak V, van Ommeren M, Yasamy MT, Ayuso-Mateos JL, Birbeck GL, Drummond C, Freeman M, Giannakopoulos P, Levav I, Obot IS, Omigbodun O, Patel V, Phillips M, Prince M, Rahimi-Movaghar A, Rahman A, Sander JW, Saunders JB, Servili C, Rangaswamy T, Unutzer J, Ventevogel P, Vijayakumar L, Thornicroft G, Saxena S. Evidence-based guidelines for mental, neurological, and substance use disorders in low- and middle-income countries: summary of WHO recommendations. PLoS Med. 2011 Nov;8(11):e1001122. doi: 10.1371/journal.pmed.1001122. Epub 2011 Nov 15.
PMID: 22110406
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PMID: 23925613
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PMID: 27786430
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PMID: 1737972
responsible party type: Sponsor
mesh term: Depression
sharing ipd: Undecided