<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/NCT03038347</url>
  </required_header>
  <id_info>
    <org_study_id>Cross-cultural psychotherapy</org_study_id>
    <nct_id>NCT03038347</nct_id>
  </id_info>
  <brief_title>Training of Cross-cultural Competencies in Psychotherapists</brief_title>
  <official_title>Evaluation of an Internet-based Training Program to Improve Cross-cultural Competencies in Psychotherapists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philipps University Marburg Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Humboldt-Universität zu Berlin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Philipps University Marburg Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a web-based training program with&#xD;
      text-based information as well as practical exercises can improve cross-cultural competencies&#xD;
      in therapists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the number of patients from diverse cultures increases in psychotherapeutic care,&#xD;
      cross-cultural competencies of therapists become increasingly important. In particular,&#xD;
      mental health care of patients with immigration background needs to be improved as studies&#xD;
      show that these patients drop out of treatment more often and benefit less from therapy. In&#xD;
      addition, patients with immigration background and refugees show higher prevalences in mental&#xD;
      illnesses. Nevertheless, evaluated training programs to improve cross-cultural competencies&#xD;
      in psychotherapists are lacking. In particular, web-based training programs, which allow&#xD;
      therapists to work time-flexible and at their own pace on a training, are, to date, missing&#xD;
      completely.&#xD;
&#xD;
      For the current study, a web-based training program to improve therapists' cross-cultural&#xD;
      competencies was developed. It is based on existing conceptions of cross-cultural&#xD;
      competencies. The developed program consists of six modules with the following contents:&#xD;
      definitions and conceptions of culture, the role of cross-cultural competencies in&#xD;
      psychotherapy, the influence of prejudices and discrimination as well as the role of&#xD;
      migration and acculturation, and culturally sensitive diagnostics. The modules contain&#xD;
      PDF-files with text-based information, video files, case studies with associated questions as&#xD;
      well as practical exercises. The main focus of the training is the participants'&#xD;
      self-reflection concerning their conceptions of (their own) culture and their beliefs about&#xD;
      culturally diverse patients. The training group will be compared to two other groups, i.e. an&#xD;
      education only and a waitlist control group. Whereas the waitlist control group will not&#xD;
      receive any training materials, the education only group will receive a slimmed down version&#xD;
      of the training consisting only of text-based information files.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transcultural Competencies of Psychotherapists Questionnaire (TKKP; Reichardt et. al., in prep.)</measure>
    <time_frame>pre-training, post-training (6 weeks after the start of the training); follow up (6 month after training completion)</time_frame>
    <description>Change in cross-cultural psychotherapeutic competencies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multicultural Counseling Inventory (MCI; Sodowsky, 1994)</measure>
    <time_frame>pre-training, post-training (6 weeks after the start of the training); follow-up (6 month after training completion)</time_frame>
    <description>Change in cross-cultural psychotherapeutic competencies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cultural sensitivity in actual psychotherapeutic work I</measure>
    <time_frame>pre-training, post-training (6 weeks after the start of the training), follow-up (6 month after training completion)</time_frame>
    <description>Percentage of culturally diverse patients currently in treatment in own actual psychotherapeutic work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cultural sensitivity in actual psychotherapeutic work II</measure>
    <time_frame>pre-training, post-training (6 weeks after the start of the training), follow-up (6 month after training completion)</time_frame>
    <description>Willingness to treat culturally diverse patients in own actual psychotherapeutic work (rating scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cultural sensitivity in actual psychotherapeutic work III</measure>
    <time_frame>pre-training, post-training (6 weeks after the start of the training), follow-up (6 month after training completion)</time_frame>
    <description>Satisfaction with cross-cultural therapies provided in actual psychotherapeutic work (rating scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cultural sensitivity in actual psychotherapeutic work IV</measure>
    <time_frame>pre-training, post-training (6 weeks after the start of the training), follow-up (6 month after training completion)</time_frame>
    <description>Perceived competence in the currently provided cross-cultural therapies (rating scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge regarding the provision of cross-cultural psychotherapy</measure>
    <time_frame>post-training (6 weeks after the start of the training)</time_frame>
    <description>Test of specific knowledge gained during the training (knowledge test in multiple choice answer format)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Training satisfaction scale</measure>
    <time_frame>post-training (6 weeks after the start of the training); follow-up (6 month after training completion)</time_frame>
    <description>Satisfaction with the training (rating scale; items assessing satisfaction with contents and structure of the developed training)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Learning success scale</measure>
    <time_frame>post-training (6 weeks after the start of the training); follow-up (6 month after training completion)</time_frame>
    <description>Rating of competencies achieved through the training for the treatment of culturally diverse patients (rating scale, rating of the degree to which certain competencies have been achieved)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cultural sensitivity in psychotherapeutic work (Behavioural change measure)</measure>
    <time_frame>post-training (6 weeks after the start of the training), 2 months after training completion; follow-up (6 month after training completion)</time_frame>
    <description>Rating of different case examples with focus on expected difficulty and effectiveness of psychotherapy (given different cases with different disorders, severity levels, and cultural backgrounds)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">173</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the training group, participants work six weeks on the training program, one module per week. The modules contain PDF-files with text-based information, video files, case studies with associated questions as well as practical exercises that participants perform independently. The main purpose of this intervention is the improvement of cross-cultural competencies in psychotherapists</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the education only group, participants work six weeks on a slimmed down version of the training program. The modules only contain text-based information without any exercises. After completion, participants receive access to the practical exercises, case studies and video files as well. Main purpose of the education only group is to determine whether the practical part of the training program can offer additional benefit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Initially, participants do not receive any training contents. After a six week waiting period, they can participate in the training program as well. Modules are equivalent to those of the training group. Purpose of this group is to determine whether the training program is effective.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training</intervention_name>
    <description>Six modules containing PDF-files with text-based information, video files, case studies with associated questions and practical exercises. Participants can download the modules and associated materials from an online platform they need to register for. They receive access to modules and associated exercises once a week. After six weeks the training is completed.</description>
    <arm_group_label>Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education only</intervention_name>
    <description>Six modules containing only PDF-files with text-based information. Participants can download the modules and associated materials from an online platform they need to register for. They receive access to modules once a week. After six weeks the education is completed.</description>
    <arm_group_label>Education only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  current psychotherapeutic work&#xD;
&#xD;
          -  Internet access&#xD;
&#xD;
          -  sufficient German language skills&#xD;
&#xD;
          -  ongoing or completed training in Psychotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  too much previous knowledge about cross-cultural competencies (&gt; 10h training)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cornelia Weise, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Psychology and Psychotherapy, Philipps University Marburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Winfried Rief, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Clinical Psychology and Psychotherapy, Philipps University Marburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulrike von Lersner, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Transcultural Psychology, Humboldt University Berlin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gerhard Andersson, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Behavioural Sciences and Learning, Linköping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Philipps University Marburg</name>
      <address>
        <city>Marburg</city>
        <state>Hessen</state>
        <zip>35037</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Fazel M, Wheeler J, Danesh J. Prevalence of serious mental disorder in 7000 refugees resettled in western countries: a systematic review. Lancet. 2005 Apr 9-15;365(9467):1309-14. doi: 10.1016/S0140-6736(05)61027-6.</citation>
    <PMID>15823380</PMID>
  </reference>
  <reference>
    <citation>Gaitanides, S. (2001). Zugangsbarrieren von Migrant (inn) en zu den sozialen und psychosozialen Diensten und Strategien interkultureller Öffnung. In G. Auernheimer (Hrsg.), Migration als Herausforderung für pädagogische Institutionen (pp. 181-194). Wiesbaden: Springer Fachmedien.</citation>
  </reference>
  <reference>
    <citation>Mösko, M., Baschin, K., Längst, G., &amp; von Lersner, U. (2012). Interkulturelle Trainings für die psychosoziale Versorgung. Psychotherapeut, 57(1), 15-21.</citation>
  </reference>
  <reference>
    <citation>Mosko MO, Pradel S, Schulz H. [The care of people with a migration background in psychosomatic rehabilitation]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Apr;54(4):465-74. doi: 10.1007/s00103-011-1245-x. German.</citation>
    <PMID>21465403</PMID>
  </reference>
  <reference>
    <citation>Reichardt, J., von Lersner, U., Rief, W., &amp; Weise, C. (in Vorb.). Entwicklung und Validierung des Inventars zur Erfassung transkultureller Kompetenzen bei Psychotherapeuten (TKKP).</citation>
  </reference>
  <reference>
    <citation>Sodowsky, G. R., Taffe, R. C., Gutkin, T. B., &amp; Wise, S. L. (1994). Development of the Multicultural Counseling Inventory: A Self-Report Measure of Multicultural Competencies. Journal of Counseling Psychology, 41(2), 137-148.</citation>
  </reference>
  <reference>
    <citation>Sue, D. W., Arredondo, P., &amp; McDavis, R. J. (1992). Multicultural counseling competencies and standards: A call to the profession. Journal of Counseling &amp; Development, 70(4), 477-486.</citation>
  </reference>
  <reference>
    <citation>Reichardt, J., von Lersner, U., Rief, W., &amp; Weise, C. (2017). Wie lassen sich transkulturelle Kompetenzen bei Psychotherapeuten steigern? Vorstellung eines webbasierten Trainingsprogramms [How to improve cross-cultural competencies in psychotherapists? Introduction of a web-based training program]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 65(3), 155-165. doi:10.1024/1661-4747/a000316</citation>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>November 6, 2022</last_update_submitted>
  <last_update_submitted_qc>November 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Philipps University Marburg Medical Center</investigator_affiliation>
    <investigator_full_name>Cornelia Weise</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>cross-cultural competencies</keyword>
  <keyword>internet-based training</keyword>
  <keyword>cognitive-behavioural therapy (CBT)</keyword>
  <keyword>psychotherapy training</keyword>
  <keyword>competence training</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03038347
org study id: Cross-cultural psychotherapy
nct id: NCT03038347
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether a web-based training program with
      text-based information as well as practical exercises can improve cross-cultural competencies
      in therapists.
As the number of patients from diverse cultures increases in psychotherapeutic care,
      cross-cultural competencies of therapists become increasingly important. In particular,
      mental health care of patients with immigration background needs to be improved as studies
      show that these patients drop out of treatment more often and benefit less from therapy. In
      addition, patients with immigration background and refugees show higher prevalences in mental
      illnesses. Nevertheless, evaluated training programs to improve cross-cultural competencies
      in psychotherapists are lacking. In particular, web-based training programs, which allow
      therapists to work time-flexible and at their own pace on a training, are, to date, missing
      completely.

      For the current study, a web-based training program to improve therapists' cross-cultural
      competencies was developed. It is based on existing conceptions of cross-cultural
      competencies. The developed program consists of six modules with the following contents:
      definitions and conceptions of culture, the role of cross-cultural competencies in
      psychotherapy, the influence of prejudices and discrimination as well as the role of
      migration and acculturation, and culturally sensitive diagnostics. The modules contain
      PDF-files with text-based information, video files, case studies with associated questions as
      well as practical exercises. The main focus of the training is the participants'
      self-reflection concerning their conceptions of (their own) culture and their beliefs about
      culturally diverse patients. The training group will be compared to two other groups, i.e. an
      education only and a waitlist control group. Whereas the waitlist control group will not
      receive any training materials, the education only group will receive a slimmed down version
      of the training consisting only of text-based information files.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Transcultural Competencies of Psychotherapists Questionnaire (TKKP; Reichardt et. al., in prep.)
time frame: pre-training, post-training (6 weeks after the start of the training); follow up (6 month after training completion)
description: Change in cross-cultural psychotherapeutic competencies
measure: Multicultural Counseling Inventory (MCI; Sodowsky, 1994)
time frame: pre-training, post-training (6 weeks after the start of the training); follow-up (6 month after training completion)
description: Change in cross-cultural psychotherapeutic competencies
measure: Cultural sensitivity in actual psychotherapeutic work I
time frame: pre-training, post-training (6 weeks after the start of the training), follow-up (6 month after training completion)
description: Percentage of culturally diverse patients currently in treatment in own actual psychotherapeutic work
measure: Cultural sensitivity in actual psychotherapeutic work II
time frame: pre-training, post-training (6 weeks after the start of the training), follow-up (6 month after training completion)
description: Willingness to treat culturally diverse patients in own actual psychotherapeutic work (rating scale)
measure: Cultural sensitivity in actual psychotherapeutic work III
time frame: pre-training, post-training (6 weeks after the start of the training), follow-up (6 month after training completion)
description: Satisfaction with cross-cultural therapies provided in actual psychotherapeutic work (rating scale)
measure: Cultural sensitivity in actual psychotherapeutic work IV
time frame: pre-training, post-training (6 weeks after the start of the training), follow-up (6 month after training completion)
description: Perceived competence in the currently provided cross-cultural therapies (rating scale)
measure: Knowledge regarding the provision of cross-cultural psychotherapy
time frame: post-training (6 weeks after the start of the training)
description: Test of specific knowledge gained during the training (knowledge test in multiple choice answer format)
measure: Training satisfaction scale
time frame: post-training (6 weeks after the start of the training); follow-up (6 month after training completion)
description: Satisfaction with the training (rating scale; items assessing satisfaction with contents and structure of the developed training)
measure: Learning success scale
time frame: post-training (6 weeks after the start of the training); follow-up (6 month after training completion)
description: Rating of competencies achieved through the training for the treatment of culturally diverse patients (rating scale, rating of the degree to which certain competencies have been achieved)
measure: Cultural sensitivity in psychotherapeutic work (Behavioural change measure)
time frame: post-training (6 weeks after the start of the training), 2 months after training completion; follow-up (6 month after training completion)
description: Rating of different case examples with focus on expected difficulty and effectiveness of psychotherapy (given different cases with different disorders, severity levels, and cultural backgrounds)
arm group label: Training
arm group type: Experimental
description: In the training group, participants work six weeks on the training program, one module per week. The modules contain PDF-files with text-based information, video files, case studies with associated questions as well as practical exercises that participants perform independently. The main purpose of this intervention is the improvement of cross-cultural competencies in psychotherapists
arm group label: Education only
arm group type: Active Comparator
description: In the education only group, participants work six weeks on a slimmed down version of the training program. The modules only contain text-based information without any exercises. After completion, participants receive access to the practical exercises, case studies and video files as well. Main purpose of the education only group is to determine whether the practical part of the training program can offer additional benefit.
arm group label: Waiting control
arm group type: No Intervention
description: Initially, participants do not receive any training contents. After a six week waiting period, they can participate in the training program as well. Modules are equivalent to those of the training group. Purpose of this group is to determine whether the training program is effective.
intervention type: Behavioral
intervention name: Training
description: Six modules containing PDF-files with text-based information, video files, case studies with associated questions and practical exercises. Participants can download the modules and associated materials from an online platform they need to register for. They receive access to modules and associated exercises once a week. After six weeks the training is completed.
arm group label: Training
intervention type: Behavioral
intervention name: Education only
description: Six modules containing only PDF-files with text-based information. Participants can download the modules and associated materials from an online platform they need to register for. They receive access to modules once a week. After six weeks the education is completed.
arm group label: Education only
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cornelia Weise, PhD
role: Principal Investigator
affiliation: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
last name: Winfried Rief, PhD
role: Study Chair
affiliation: Department of Clinical Psychology and Psychotherapy, Philipps University Marburg
last name: Ulrike von Lersner, PhD
role: Study Chair
affiliation: Department of Transcultural Psychology, Humboldt University Berlin
last name: Gerhard Andersson, PhD
role: Study Chair
affiliation: Department of Behavioural Sciences and Learning, Linköping University
facility: 
country: Germany
citation: Fazel M, Wheeler J, Danesh J. Prevalence of serious mental disorder in 7000 refugees resettled in western countries: a systematic review. Lancet. 2005 Apr 9-15;365(9467):1309-14. doi: 10.1016/S0140-6736(05)61027-6.
PMID: 15823380
citation: Gaitanides, S. (2001). Zugangsbarrieren von Migrant (inn) en zu den sozialen und psychosozialen Diensten und Strategien interkultureller Öffnung. In G. Auernheimer (Hrsg.), Migration als Herausforderung für pädagogische Institutionen (pp. 181-194). Wiesbaden: Springer Fachmedien.
citation: Mösko, M., Baschin, K., Längst, G., & von Lersner, U. (2012). Interkulturelle Trainings für die psychosoziale Versorgung. Psychotherapeut, 57(1), 15-21.
citation: Mosko MO, Pradel S, Schulz H. [The care of people with a migration background in psychosomatic rehabilitation]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Apr;54(4):465-74. doi: 10.1007/s00103-011-1245-x. German.
PMID: 21465403
citation: Reichardt, J., von Lersner, U., Rief, W., & Weise, C. (in Vorb.). Entwicklung und Validierung des Inventars zur Erfassung transkultureller Kompetenzen bei Psychotherapeuten (TKKP).
citation: Sodowsky, G. R., Taffe, R. C., Gutkin, T. B., & Wise, S. L. (1994). Development of the Multicultural Counseling Inventory: A Self-Report Measure of Multicultural Competencies. Journal of Counseling Psychology, 41(2), 137-148.
citation: Sue, D. W., Arredondo, P., & McDavis, R. J. (1992). Multicultural counseling competencies and standards: A call to the profession. Journal of Counseling & Development, 70(4), 477-486.
citation: Reichardt, J., von Lersner, U., Rief, W., & Weise, C. (2017). Wie lassen sich transkulturelle Kompetenzen bei Psychotherapeuten steigern? Vorstellung eines webbasierten Trainingsprogramms [How to improve cross-cultural competencies in psychotherapists? Introduction of a web-based training program]. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 65(3), 155-165. doi:10.1024/1661-4747/a000316
responsible party type: Principal Investigator
investigator affiliation: Philipps University Marburg Medical Center
investigator full name: Cornelia Weise
investigator title: Assistant Professor
sharing ipd: No