Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-02-23 @ 1:52 PM
Study NCT ID:
NCT03233958
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Psychosocial Effects of Systemic / Family Constellation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'konkoly.thege.barna@gmail.com', 'phone': '+1 (705) 549 3181', 'title': 'Barna Konkoly-Thege', 'phoneExt': '2614', 'organization': 'University of Toronto'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The most important shortcoming of the present study is the non-controlled nature of its design and thus the possibility that the reported beneficial changes are the results of external factors. A further limitation of the present study is the low participation rate of men (even if it corresponds to anecdotic evidence on the real-life gender ratio of participants) and the large attrition rate limiting the generalizability of the findings to all family constellation participants.'}}, 'adverseEventsModule': {'timeFrame': '6 months postintervention', 'description': 'Two items were developed by the investigators to screen for adverse outcomes: "Have you experienced any negative change in relation to your mental or physical health during or since the family constellation workshop?". If respondents answered affirmatively, it was also asked if they believed the changes were associated with the intervention (yes/no/unsure). Below we report all adverse events, including those participants were sure were not related to the intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Workshop Participants', 'description': 'Participants of systemic / family constellation workshops', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 17, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Negative mental health outcomes', 'notes': 'E.g., slightly more addictive symptoms, increased tensions in marriage, increased fear of aging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Negative physical health outcomes', 'notes': 'E.g., unintended weight gain, exhaustion, or hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Combined mental and physical negative outcomes', 'notes': 'Avolition combined with exhaustion, increased negative affect in combination with unintended weight gain and exhaustion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in General Severity Index Scores on the Brief Symptom Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Family Constellation Participants', 'description': 'Participants of systemic / family constellation workshops'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': '1-month postintervention', 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': '6-month postintervention', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.53', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the single group, pre-post design, the analysis simply investigated the effect of time.'}], 'paramType': 'MEAN', 'timeFrame': 'Before, 1- and 6-month after the intervention', 'description': "The Hungarian version of the Brief Symptom Inventory was used to measure an individual's overall psychopathology level. This tool consists of 53 items covering nine symptom dimensions: somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. Out of the three global measures of pathology and distress, the General Severity Index (GSI, mean of all items) was used in the present study. The range of this measure is 0-4, higher scores indicating worse mental health (more psychopathological symptoms). The range of this measure is 0-4, higher scores indicating worse mental health (more psychopathological symptoms).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing both the baseline and the one- and 6-month follow-up questionnaire.'}, {'type': 'SECONDARY', 'title': 'Change in Scores on the Experience in Personal Social Systems Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Family Constellation Participants', 'description': 'Participants of systemic / family constellation workshops'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '44.97', 'spread': '11.33', 'groupId': 'OG000'}]}]}, {'title': '1-month postintervention', 'categories': [{'measurements': [{'value': '49.67', 'spread': '13.76', 'groupId': 'OG000'}]}]}, {'title': '6-month postintervention', 'categories': [{'measurements': [{'value': '50.52', 'spread': '13.42', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '5.55', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the single group, pre-post design, the analysis simply investigated the effect of time.'}], 'paramType': 'MEAN', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'The Experience in Personal Social Systems Questionnaire assesses social aspects of quality of life (how the respondent feels about their own personal social system). Total score is created by adding all 12 items and the range is 12-72, higher scores indicating better social quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Family Constellation Participants', 'description': 'Participants of systemic / family constellation workshops'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.89', 'spread': '4.26', 'groupId': 'OG000'}]}]}, {'title': '1-month postintervention', 'categories': [{'measurements': [{'value': '5.55', 'spread': '4.33', 'groupId': 'OG000'}]}]}, {'title': '6-month postintervention', 'categories': [{'measurements': [{'value': '6.35', 'spread': '4.71', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.54', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the single group, pre-post design, the analysis simply investigated the effect of time.'}], 'paramType': 'MEAN', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'The Patient Health Questionnaire Somatic Symptom Severity Scale 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). Total score is the sum of all items, range is 0-30, higher scores indicate more somatic symptoms (worse physical health).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Scores on the SCOFF Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Family Constellation Participants', 'description': 'Participants of systemic / family constellation workshops'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.65', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': '1-month postintervention', 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': '6-months postintervention', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.90', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.076', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.18', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the single group, pre-post design, the analysis simply investigated the effect of time.'}], 'paramType': 'MEAN', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'The SCOFF Questionnaire is a brief screener to detect increased risk for eating disorders. The total score is created by summing all five items, leading to a score range of 0-5. Higher scores indicate higher eating disorder risk.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Scores on ad Hoc Items to Assess Behavioral and Substance-related Addictions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Family Constellation Participants', 'description': 'Participants of systemic / family constellation workshops'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.73', 'spread': '3.10', 'groupId': 'OG000'}]}]}, {'title': '1-month postintervention', 'categories': [{'measurements': [{'value': '6.35', 'spread': '2.43', 'groupId': 'OG000'}]}]}, {'title': '6-month postintervention', 'categories': [{'measurements': [{'value': '6.22', 'spread': '2.65', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.147', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.51', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the single group, pre-post design, the analysis simply investigated the effect of time.'}], 'paramType': 'MEAN', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'Items assess perceived problem severity with behavioral and substance-related addictions. The total scores is created by summing all four items resulting in a score range of 4-28. Higher scores indicate more severe behavioral and substance-related addiction severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Scores on the Meaning in Life Questionnaire / Presence of Meaning Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Family Constellation Participants', 'description': 'Participants of systemic / family constellation workshops'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.87', 'spread': '8.37', 'groupId': 'OG000'}]}]}, {'title': '1-month postintervention', 'categories': [{'measurements': [{'value': '23.79', 'spread': '8.95', 'groupId': 'OG000'}]}]}, {'title': '6-month postintervention', 'categories': [{'measurements': [{'value': '23.94', 'spread': '8.44', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.197', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.07', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the single group, pre-post design, the analysis simply investigated the effect of time.'}], 'paramType': 'MEAN', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': "The Presence of Meaning Subscale of the Meaning in Life Questionnaire assesses the perceived level of meaning in an individual's life. Total score is created by summing all 5 subscale items resulting a score range of 5-35. Higher scores indicate a higher sense of meaning in life (better mental health).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Scores on the World Health Organization Wellbeing Index (WBI-5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Family Constellation Participants', 'description': 'Participants of systemic / family constellation workshops'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.01', 'spread': '3.27', 'groupId': 'OG000'}]}]}, {'title': '1-month postintervention', 'categories': [{'measurements': [{'value': '9.10', 'spread': '3.29', 'groupId': 'OG000'}]}]}, {'title': '6-months postintervention', 'categories': [{'measurements': [{'value': '9.26', 'spread': '3.46', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.25', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Due to the single group, pre-post design, the analysis simply investigated the effect of time.'}], 'paramType': 'MEAN', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'The World Health Organization Wellbeing Index captures the general well-being of the individual. Total score is created by summing all 5 items, resulting in a score range of 0-15. Higher scores indicate better overall well-being.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participant-perceived Iatrogenic Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Workshop Participants', 'description': 'Participants of systemic / family constellation workshops\n\nSystemic / family constellation: 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\\].'}], 'classes': [{'title': '1 month', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month after and 6 months after the intervention', 'description': 'Qualitative responses on the perceived iatrogenic effects of the intervention were collected using-open ended, ad hoc questions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Family Constellation Participants', 'description': 'Participants of systemic / family constellation workshops'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Workshop Participants', 'description': 'Participants of systemic / family constellation workshops\n\nSystemic / family constellation: 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\\].'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.9', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '152', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '182', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'General Severity Index of the Brief Symptom Inventory', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '0.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Hungarian version of the Brief Symptom Inventory was used to measure an individual's overall psychopathology level. This tool consists of 53 items covering nine symptom dimensions: somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. Out of the three global measures of pathology and distress, the General Severity Index (GSI, mean of all items) was used in the present study. The range of this measure is 0-4, higher scores indicating worse mental health (more psychopathological symptoms).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-19', 'size': 215072, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-04-11T10:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2017-07-25', 'resultsFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-11', 'studyFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in General Severity Index Scores on the Brief Symptom Inventory', 'timeFrame': 'Before, 1- and 6-month after the intervention', 'description': "The Hungarian version of the Brief Symptom Inventory was used to measure an individual's overall psychopathology level. This tool consists of 53 items covering nine symptom dimensions: somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. Out of the three global measures of pathology and distress, the General Severity Index (GSI, mean of all items) was used in the present study. The range of this measure is 0-4, higher scores indicating worse mental health (more psychopathological symptoms). The range of this measure is 0-4, higher scores indicating worse mental health (more psychopathological symptoms)."}], 'secondaryOutcomes': [{'measure': 'Change in Scores on the Experience in Personal Social Systems Questionnaire', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'The Experience in Personal Social Systems Questionnaire assesses social aspects of quality of life (how the respondent feels about their own personal social system). Total score is created by adding all 12 items and the range is 12-72, higher scores indicating better social quality of life.'}, {'measure': 'Change in Scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15)', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'The Patient Health Questionnaire Somatic Symptom Severity Scale 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). Total score is the sum of all items, range is 0-30, higher scores indicate more somatic symptoms (worse physical health).'}, {'measure': 'Change in Scores on the SCOFF Questionnaire', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'The SCOFF Questionnaire is a brief screener to detect increased risk for eating disorders. The total score is created by summing all five items, leading to a score range of 0-5. Higher scores indicate higher eating disorder risk.'}, {'measure': 'Change in Scores on ad Hoc Items to Assess Behavioral and Substance-related Addictions', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'Items assess perceived problem severity with behavioral and substance-related addictions. The total scores is created by summing all four items resulting in a score range of 4-28. Higher scores indicate more severe behavioral and substance-related addiction severity.'}, {'measure': 'Change in Scores on the Meaning in Life Questionnaire / Presence of Meaning Subscale', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': "The Presence of Meaning Subscale of the Meaning in Life Questionnaire assesses the perceived level of meaning in an individual's life. Total score is created by summing all 5 subscale items resulting a score range of 5-35. Higher scores indicate a higher sense of meaning in life (better mental health)."}, {'measure': 'Change in Scores on the World Health Organization Wellbeing Index (WBI-5)', 'timeFrame': 'Before, 1 month after and 6 months after the intervention', 'description': 'The World Health Organization Wellbeing Index captures the general well-being of the individual. Total score is created by summing all 5 items, resulting in a score range of 0-15. Higher scores indicate better overall well-being.'}, {'measure': 'Participant-perceived Iatrogenic Effects', 'timeFrame': '1 month after and 6 months after the intervention', 'description': 'Qualitative responses on the perceived iatrogenic effects of the intervention were collected using-open ended, ad hoc questions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild to Moderate Psychopathological Symptoms']}, 'referencesModule': {'references': [{'pmid': '23957767', 'type': 'BACKGROUND', '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': '25264190', 'type': 'BACKGROUND', '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': '24251855', 'type': 'BACKGROUND', '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': '33528854', 'type': 'BACKGROUND', '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': '36256988', 'type': 'RESULT', 'citation': 'Konkoly Thege B, Somogyi B, Szabo GS. The Effectiveness of Family Constellation Therapy in Reducing Psychopathological Symptoms in a Naturalistic Setting. Psychiatr Danub. 2022 Fall;34(3):497-505. doi: 10.24869/psyd.2022.497.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nConsidering 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.\n\nIt is hypothesized that participation in a family constellation seminar might decrease potential psychological symptoms and will not result in adverse outcomes.', 'detailedDescription': 'Family / systemic constellation therapy is a short-term group psychotherapy aiming to help clients better understand and resolve their conflicts within their personal systems, which in turn might lead to a decrease in psychopathological or functional somatic symptoms. The personal system addressed is most often the family but other inter- or intrapersonal systems (e.g., ego parts, victim-perpetrator dyads) can also be the target of the intervention; the term "family constellation therapy" is used throughout the manuscript in this broader sense. This therapeutic modality was developed in Germany in the early \'90s integrating elements of - among others - psychodrama, family sculptures, contextual therapy, and certain South-African aboriginal traditions and has become particularly popular in Europe and South America and even became part of the public health care system in certain countries. Compared to its use by thousands of therapists of various theoretical and professional backgrounds all over the world, little effort has been made to generate empirical data regarding the effectiveness and safety of this intervention.\n\nWe believe that the large discrepancy between the relatively high level of penetration into the practice of complementary and alternative medicine versus the low quantity of evidence on effectiveness stems largely from academic psychology\'s reluctance to engage with at least two metaphysical / anthropological postulates of family constellation therapy. Firstly, the theory of family constellation therapy assumes that an individual\'s mental and physical health might be significantly influenced by major life events of other members of the personal system even if they lived generations before (e.g., the death of a mother during childbirth might have an effect on her descendants\' anxiety level and reproductive success for several generations even if the original event has never been talked about in the descendant\'s life). While - due to recent developments in epigenetics and the better understanding of transgenerational trauma - this and similar concepts are less shocking to the academic community than they were 3-4 decades ago when family constellation therapy was developed, they are still in sharp contradiction with the common understanding that the etiological factors of any physical or mental illness are to be sought in bio-psycho-social events, situations, or conditions occurring or existing around and after the individual\'s conception.\n\nThe second distinctive feature is that the theory of family constellation therapy assumes that the life-altering, relevant pieces of information are \'stored\' and somehow can be \'downloaded\' not just automatically and unconsciously by the members of the same system but intentionally by outsiders as well. This accessibility of system-relevant information makes it possible that participants of the single-occasion intervention (who are unknown to each other) are able to perceive and verbalize thoughts, physical perceptions, emotions associated with the history of the system, often unknown even to the recipient of the given constellation. This somewhat \'mystical\' re-presentation of unknown facts and hidden dynamics makes it possible for the recipient of the constellation to better understand the etiology of their mental or physical symptoms and intentionally change these very same dynamics. How this storage and access of system-relevant information occurs is highly debated and uncertain; the most-widely held explanation of these processes use the morphic / morphogenic field and -resonance concepts (cf. storage) of the biologist Rupert Sheldrake in combination with the function of mirror neurons (cf. way of accessing stored information by non-members of the system).\n\nRegardless of whether we fully understand the exact mechanisms of action of a therapeutic modality and if its certain assumptions fit the contemporary paradigms of health sciences, we argue that collecting empirical data on an intervention\'s effectiveness and safety is a public health necessity, especially if it is so widely used as family constellation therapy (and it certainly could provide further impetus to the study of the mechanisms of action and the potential reconsideration of the accuracy of our paradigms).\n\nThe very limited number of previous prospective, peer-reviewed studies into family constellation therapy\'s therapeutic effectiveness reported that the intervention was effective in reducing general, non-diagnosis-specific psychopathology and psychological distress, decreasing the intensity of dermatological symptoms, as well as improving quality of life and functioning in interpersonal relationships. A recent systematic review summarizing both the peer-reviewed and the grey literature on family constellation therapy concluded that further studies into its effectiveness are greatly needed, especially if 1) using at least a mid-term time frame (≥6 months) to evaluate client outcomes, 2) employing active monitoring (not just passive surveillance) of potential iatrogenic effects, and 3) providing information on the presence or absence of therapist effects. The aim of the present study was to collect and analyze further data from the real life setting on family constellation therapy\'s effectiveness in improving mental health and its tolerability in line with these recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals from the general population who seek help through family constellation seminars for various mild to moderate psychological symptoms.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-referred and registered for a family constellation workshop with one of the therapists (clinical psychologist / psychiatrist) who were willing to collaborate with the researchers of the present study\n\nExclusion Criteria:\n\n* Age under 18 years\n* Currently suffers from a diagnosed mental disorder\n* Participated actively (not merely as a "representative") in a family constellation intervention in the 12 months preceding baseline assessment'}, 'identificationModule': {'nctId': 'NCT03233958', 'briefTitle': 'The Psychosocial Effects of Systemic / Family Constellation', 'organization': {'class': 'OTHER', 'fullName': 'Károli Gáspár University of the Reformed Church in Hungary'}, 'officialTitle': 'The Psychosocial Effects of Systemic / Family Constellation: An Observational Follow-up Study', 'orgStudyIdInfo': {'id': '325/2017/P'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Workshop participants', 'description': 'Participants of systemic / family constellation workshops', 'interventionNames': ['Behavioral: Systemic / family constellation']}], 'interventions': [{'name': 'Systemic / family constellation', 'type': 'BEHAVIORAL', '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\\].', 'armGroupLabels': ['Workshop participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1037', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Károli Gáspár University of the Reformed Church in Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Barna Konkoly Thege, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Psychiatry, Univeristy of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', '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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Károli Gáspár University of the Reformed Church in Hungary', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gergely Sándor Szabó, PhD', 'investigatorAffiliation': 'Károli Gáspár University of the Reformed Church in Hungary'}}}}