<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/NCT03233958</url>
  </required_header>
  <id_info>
    <org_study_id>325/2017/P</org_study_id>
    <nct_id>NCT03233958</nct_id>
  </id_info>
  <brief_title>The Psychosocial Effects of Systemic / Family Constellation</brief_title>
  <official_title>The Psychosocial Effects of Systemic / Family Constellation: An Observational Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Károli Gáspár University of the Reformed Church in Hungary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Károli Gáspár University of the Reformed Church in Hungary</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 investigate the psychosocial effects of systemic / family&#xD;
      constellation. The method of systemic / family constellation refers to an approach which&#xD;
      integrates ideas from family systems therapy with elements from psychodrama. The&#xD;
      constellations are conducted in a group based seminar-setting, each seminar lasting two days.&#xD;
&#xD;
      Considering the very limited amount of empirical data on this method, the study design is a&#xD;
      simple pre-post one with a 6-months follow-up. The study will be observational: the&#xD;
      researchers will not manipulate who receives the intervention; instead they invite all&#xD;
      clients (individuals from the general population) attending these therapeutic workshops run&#xD;
      independently of the research process. Given the limited amount of evidence on this&#xD;
      therapeutic method, special attention will be given to monitor potential adverse outcomes to&#xD;
      establish intervention safety.&#xD;
&#xD;
      It is hypothesized that participation in a family constellation seminar might decrease&#xD;
      potential psychological symptoms and will not result in adverse outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in scores on the Brief Symptom Inventory</measure>
    <time_frame>Before, 1 month after and 6 months after the intervention</time_frame>
    <description>A broad spectrum of psychopathological symptoms including somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in answers to ad hoc items developed for qualitative analysis</measure>
    <time_frame>1 and 6 months after the intervention</time_frame>
    <description>These items are developed by the study authors to 1) screen for any potential adverse outcomes as a result of the intervention, 2) better understand the treatment goals of individuals participating in this form of therapy and how these relate to what they perceive as the outcome of the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in scores on the Experience in Personal Social Systems Questionnaire</measure>
    <time_frame>Before, 1 month after and 6 months after the intervention</time_frame>
    <description>Assessment of how the members of a personal social system experience their situation within that system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15)</measure>
    <time_frame>Before, 1 month after and 6 months after the intervention</time_frame>
    <description>The PHQ-15 includes 15 somatic symptoms (headache, stomach pain, chest pain, dizziness, etc.) that account for more than 90% of symptoms seen in primary care (exclusive of upper respiratory symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on the SCOFF</measure>
    <time_frame>Before, 1 month after and 6 months after the intervention</time_frame>
    <description>The SCOFF is a brief screener to detect increased risk for eating disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on ad hoc items to assess behavioral and substance-related addictions</measure>
    <time_frame>Before, 1 month after and 6 months after the intervention</time_frame>
    <description>Items assess perceived problem severity with addictions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on the Meaning in Life Questionnaire (MLQ)</measure>
    <time_frame>Before, 1 month after and 6 months after the intervention</time_frame>
    <description>The MLQ assesses the perceived level of the presence and search for meaning in an individual's life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scores on the World Health Organization Wellbeing Index (WBI-5)</measure>
    <time_frame>Before, 1 month after and 6 months after the intervention</time_frame>
    <description>The WBI-5 captures the general well-being of the individuals</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">182</enrollment>
  <condition>Mild to Moderate Psychopathological Symptoms</condition>
  <arm_group>
    <arm_group_label>Workshop participants</arm_group_label>
    <description>Participants of systemic / family constellation workshops</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Systemic / family constellation</intervention_name>
    <description>Systemic / family constellation integrates elements from psychodrama, family sculpture, and spontaneous dramatizations of intra- and interpersonal processes, while spatially visualizing family dynamics. Family constellations stimulate change through the following ways: 1) making visible the spatial arrangement of relationships within a conflictual system; 2) providing access to the insights of unrelated third parties regarding the sensations, feelings, and thoughts they experienced while representing family members within the constellation; and 3) making observable (from the outside) and experienceable (from within) the transformation of the problem constellation into the solution constellation [Hunger, Weinhold, Bornhäuser, Link, &amp; Schweitzer, 2015].</description>
    <arm_group_label>Workshop participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals from the general population who seek help through family constellation seminars&#xD;
        for various mild to moderate psychological symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-referred and registered for a family constellation workshop with one of the&#xD;
             therapists (clinical psychologist / psychiatrist) who were willing to collaborate with&#xD;
             the researchers of the present study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years&#xD;
&#xD;
          -  Currently suffers from a diagnosed mental disorder&#xD;
&#xD;
          -  Participated actively (not merely as a &quot;representative&quot;) in a family constellation&#xD;
             intervention in the 12 months preceding baseline assessment&#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>Barna Konkoly Thege, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Psychiatry, Univeristy of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Károli Gáspár University of the Reformed Church in Hungary</name>
      <address>
        <city>Budapest</city>
        <zip>1037</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <reference>
    <citation>Weinhold J, Hunger C, Bornhauser A, Link L, Rochon J, Wild B, Schweitzer J. Family constellation seminars improve psychological functioning in a general population sample: results of a randomized controlled trial. J Couns Psychol. 2013 Oct;60(4):601-9. doi: 10.1037/a0033539. Epub 2013 Aug 19.</citation>
    <PMID>23957767</PMID>
  </reference>
  <reference>
    <citation>Hunger C, Weinhold J, Bornhauser A, Link L, Schweitzer J. Mid- and long-term effects of family constellation seminars in a general population sample: 8- and 12-month follow-up. Fam Process. 2015 Jun;54(2):344-58. doi: 10.1111/famp.12102. Epub 2014 Sep 29.</citation>
    <PMID>25264190</PMID>
  </reference>
  <reference>
    <citation>Hunger C, Bornhauser A, Link L, Schweitzer J, Weinhold J. Improving experience in personal social systems through family constellation seminars: results of a randomized controlled trial. Fam Process. 2014 Jun;53(2):288-306. doi: 10.1111/famp.12051. Epub 2013 Nov 19.</citation>
    <PMID>24251855</PMID>
  </reference>
  <reference>
    <citation>Konkoly Thege B, Petroll C, Rivas C, Scholtens S. The Effectiveness of Family Constellation Therapy in Improving Mental Health: A Systematic Review. Fam Process. 2021 Jun;60(2):409-423. doi: 10.1111/famp.12636. Epub 2021 Feb 2.</citation>
    <PMID>33528854</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Károli Gáspár University of the Reformed Church in Hungary</investigator_affiliation>
    <investigator_full_name>Gergely Sándor Szabó, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The investigators have not requested permission from their study participants to make their data available to others to increase participants' sense of confidentiality and so willingness to participate in the study. As a consequence, in case of a data sharing request, the investigators would have to seek for additional explicit permission from the participants. As the investigators have committed to destroy participant contact data after finishing the study, the chances of such data sharing seem slim. However, the investigators are more than happy to conduct alternative analyses based on interested colleagues' suggestions / inquiry and share the raw output (including analytic syntax) of such analyses with those making the inquiry.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>March 21, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03233958
org study id: 325/2017/P
nct id: NCT03233958
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the psychosocial effects of systemic / family
      constellation. The method of systemic / family constellation refers to an approach which
      integrates ideas from family systems therapy with elements from psychodrama. The
      constellations are conducted in a group based seminar-setting, each seminar lasting two days.

      Considering the very limited amount of empirical data on this method, the study design is a
      simple pre-post one with a 6-months follow-up. The study will be observational: the
      researchers will not manipulate who receives the intervention; instead they invite all
      clients (individuals from the general population) attending these therapeutic workshops run
      independently of the research process. Given the limited amount of evidence on this
      therapeutic method, special attention will be given to monitor potential adverse outcomes to
      establish intervention safety.

      It is hypothesized that participation in a family constellation seminar might decrease
      potential psychological symptoms and will not result in adverse outcomes.
observational model: Case-Only
time perspective: Prospective
measure: Change in scores on the Brief Symptom Inventory
time frame: Before, 1 month after and 6 months after the intervention
description: A broad spectrum of psychopathological symptoms including somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism
measure: Change in answers to ad hoc items developed for qualitative analysis
time frame: 1 and 6 months after the intervention
description: These items are developed by the study authors to 1) screen for any potential adverse outcomes as a result of the intervention, 2) better understand the treatment goals of individuals participating in this form of therapy and how these relate to what they perceive as the outcome of the intervention
measure: Change in scores on the Experience in Personal Social Systems Questionnaire
time frame: Before, 1 month after and 6 months after the intervention
description: Assessment of how the members of a personal social system experience their situation within that system.
measure: Change in scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15)
time frame: Before, 1 month after and 6 months after the intervention
description: The PHQ-15 includes 15 somatic symptoms (headache, stomach pain, chest pain, dizziness, etc.) that account for more than 90% of symptoms seen in primary care (exclusive of upper respiratory symptoms)
measure: Change in scores on the SCOFF
time frame: Before, 1 month after and 6 months after the intervention
description: The SCOFF is a brief screener to detect increased risk for eating disorders
measure: Change in scores on ad hoc items to assess behavioral and substance-related addictions
time frame: Before, 1 month after and 6 months after the intervention
description: Items assess perceived problem severity with addictions
measure: Change in scores on the Meaning in Life Questionnaire (MLQ)
time frame: Before, 1 month after and 6 months after the intervention
description: The MLQ assesses the perceived level of the presence and search for meaning in an individual's life
measure: Change in scores on the World Health Organization Wellbeing Index (WBI-5)
time frame: Before, 1 month after and 6 months after the intervention
description: The WBI-5 captures the general well-being of the individuals
arm group label: Workshop participants
description: Participants of systemic / family constellation workshops
intervention type: Behavioral
intervention name: Systemic / family constellation
description: Systemic / family constellation integrates elements from psychodrama, family sculpture, and spontaneous dramatizations of intra- and interpersonal processes, while spatially visualizing family dynamics. Family constellations stimulate change through the following ways: 1) making visible the spatial arrangement of relationships within a conflictual system; 2) providing access to the insights of unrelated third parties regarding the sensations, feelings, and thoughts they experienced while representing family members within the constellation; and 3) making observable (from the outside) and experienceable (from within) the transformation of the problem constellation into the solution constellation [Hunger, Weinhold, Bornhäuser, Link, & Schweitzer, 2015].
arm group label: Workshop participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Barna Konkoly Thege, PhD
role: Study Director
affiliation: Department of Psychiatry, Univeristy of Toronto
facility: 
country: Hungary
citation: Weinhold J, Hunger C, Bornhauser A, Link L, Rochon J, Wild B, Schweitzer J. Family constellation seminars improve psychological functioning in a general population sample: results of a randomized controlled trial. J Couns Psychol. 2013 Oct;60(4):601-9. doi: 10.1037/a0033539. Epub 2013 Aug 19.
PMID: 23957767
citation: Hunger C, Weinhold J, Bornhauser A, Link L, Schweitzer J. Mid- and long-term effects of family constellation seminars in a general population sample: 8- and 12-month follow-up. Fam Process. 2015 Jun;54(2):344-58. doi: 10.1111/famp.12102. Epub 2014 Sep 29.
PMID: 25264190
citation: Hunger C, Bornhauser A, Link L, Schweitzer J, Weinhold J. Improving experience in personal social systems through family constellation seminars: results of a randomized controlled trial. Fam Process. 2014 Jun;53(2):288-306. doi: 10.1111/famp.12051. Epub 2013 Nov 19.
PMID: 24251855
citation: Konkoly Thege B, Petroll C, Rivas C, Scholtens S. The Effectiveness of Family Constellation Therapy in Improving Mental Health: A Systematic Review. Fam Process. 2021 Jun;60(2):409-423. doi: 10.1111/famp.12636. Epub 2021 Feb 2.
PMID: 33528854
responsible party type: Principal Investigator
investigator affiliation: Károli Gáspár University of the Reformed Church in Hungary
investigator full name: Gergely Sándor Szabó, PhD
investigator title: Assistant Professor
sharing ipd: Undecided
ipd description: The investigators have not requested permission from their study participants to make their data available to others to increase participants' sense of confidentiality and so willingness to participate in the study. As a consequence, in case of a data sharing request, the investigators would have to seek for additional explicit permission from the participants. As the investigators have committed to destroy participant contact data after finishing the study, the chances of such data sharing seem slim. However, the investigators are more than happy to conduct alternative analyses based on interested colleagues' suggestions / inquiry and share the raw output (including analytic syntax) of such analyses with those making the inquiry.
submitted: March 21, 2023