- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05051462
Efficacy of Family Constellations in the General Population
Efficacy of Family / Systemic Constellation Therapy in the General Population. A Randomized Wait-list Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Family/systemic constellation therapy is a system-oriented, short-term group counseling intervention aiming to help clients better understand and resolve their conflicts within their intra- or interpersonal systems, which in turn might lead to a decrease in psychopathological and functional somatic symptoms as well as improvement in overall quality of life. This intervention modality was developed in Germany in the early 1990s integrating elements of - among others - psychodrama, family sculptures, contextual therapy, and certain South-African aboriginal traditions.
Compared to its widespread use by therapists of various theoretical and professional backgrounds all over the world, little effort has been made to generate empirical data regarding the efficacy and safety of this intervention and the overall quality and quantity of the extant evidence is low. Authors of the only (although high-quality) previous randomized controlled trial to date into the efficacy of systemic constellations reported that the intervention was efficacious in reducing general, non-diagnosis-specific psychopathology and psychological distress both in the short- as well as middle- and long term. A recent systematic review summarizing both the peer-reviewed and the grey literature on the mental health effects of systemic constellation therapy concluded that further studies into its efficacy and effectiveness are greatly needed, especially if employing 1) a controlled, ideally randomized-controlled design, 2) at least mid-term follow-up (≥6 months) to evaluate client outcomes and 3) active monitoring of potential iatrogenic effects.
In line with these recommendations, the aim of the present study - when designed - was to collect and analyze further data on the efficacy of systemic constellation therapy in its traditional format in improving mental health. However, the COVID pandemic required the intervention providers to make substantial changes to the usual treatment protocol; therefore, the study in its final form rather serves the purpose of investigating the efficacy of a pandemic-adjusted version of family/systemic constellation workshops than that of the intervention in general.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Budapest, Hungary
- Károli Gáspár University of the Reformed Church in Hungary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ability to participate in the in-person intervention on the date randomly assigned to them
Exclusion Criteria:
- Participation in family / systemic constellation therapy within the 12 months prior to study launch
- Current mental disorder diagnosed by an eligible health care professional
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
Study participants participating in family constellation therapy between assessment 1 and 2.
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Family / systemic constellation therapy is a short-term group counseling intervention 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.
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No Intervention: Wait-list control group
Study participants participating in family constellation therapy only after all 3 assessment points.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Brief Symptom Inventory Scores
Time Frame: 1 month post-intervention
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The Brief Symptom Inventory is a a broad-spectrum measure of psychopathology covering 9 symptom dimensions: Somatization, Obsessive-compulsive symptoms, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism.
The BSI includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items, which is used here.
The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity.
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1 month post-intervention
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Change in Brief Symptom Inventory Scores
Time Frame: 6 month post-intervention
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The Brief Symptom Inventory is a a broad-spectrum measure of psychopathology covering 9 symptom dimensions: Somatization, Obsessive-compulsive symptoms, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism.
The BSI also includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items, which is used here.
The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity.
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6 month post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Eating Disorder Risk Assessed by the SCOFF Screening Test
Time Frame: 1 month post-intervention
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The SCOFF consists of five yes-or-no type questions assessing eating disorder symptoms or risk factors.
Higher scores (ranging between 0 and 5) are indicative of greater risk.
At least two positive answers (score of 2) indicate a high likelihood of an eating disorder.
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1 month post-intervention
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Change in Eating Disorder Risk Assessed by the SCOFF Screening Test
Time Frame: 6 month post-intervention
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The SCOFF consists of five yes-or-no type questions assessing eating disorder symptoms or risk factors.
Higher scores (ranging between 0 and 5) are indicative of greater risk.
At least two positive answers (score of 2) indicate a high likelihood of an eating disorder.
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6 month post-intervention
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Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G
Time Frame: 1 month post-intervention
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The SSBA-G (Generalised version of the Screener for Substance and Behavioural Addictions) is comprised of 8 items (4 items assessing substance-related and 4 assessing behavioral addictions).
Items reflect a distinct sign or symptom of potentially problematic involvement into an addictive behavior ("I did it too much;" "Once I started, I couldn't stop;" "I felt I had to do it in order to function;" and "I continued to do it, even though it caused problems").
Scores range between 8 and 56 with higher scores indicative of higher problem severity.
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1 month post-intervention
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Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G
Time Frame: 6 month post-intervention
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The SSBA-G (Generalised version of the Screener for Substance and Behavioural Addictions) is comprised of 8 items (4 items assessing substance-related and 4 assessing behavioral addictions).
Items reflect a distinct sign or symptom of potentially problematic involvement into an addictive behavior ("I did it too much;" "Once I started, I couldn't stop;" "I felt I had to do it in order to function;" and "I continued to do it, even though it caused problems").
Scores range between 8 and 56 with higher scores indicative of higher problem severity.
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6 month post-intervention
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Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers)
Time Frame: 1 month post-intervention
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The EXIS.pers assesses the subjective experiences of the individual in their personal social system (e.g.
family, circle of friends) covering four dimensions in relation to belonging, autonomy, accord, and confidence.
Scores range between 12 and 72 with higher scores are indicative of better functioning.
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1 month post-intervention
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Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers)
Time Frame: 6 month post-intervention
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The EXIS.pers assesses the subjective experiences of the individual in their personal social system (e.g.
family, circle of friends) covering four dimensions in relation to belonging, autonomy, accord, and confidence.
Scores range between 12 and 72 with higher scores are indicative of better functioning.
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6 month post-intervention
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Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)
Time Frame: 1 month post-intervention
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The Presence of Meaning Subscale of the MLQ assesses perceived level of meaningfulness in a respondent's life.
The subscale consists of 5 items, and the total scores range between 5 and 35.
Higher scores are indicative of better functioning and quality of life.
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1 month post-intervention
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Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)
Time Frame: 6 month post-intervention
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The Presence of Meaning Subscale of the MLQ assesses perceived level of meaningfulness in a respondent's life.
The subscale consists of 5 items, and the total scores range between 5 and 35.
Higher scores are indicative of better functioning and quality of life.
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6 month post-intervention
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Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS)
Time Frame: 1 month post-intervention
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The SWLS is a measure of general satisfaction with one's life.
Scores range from 5 to 35 with higher scores indicative of higher life satisfaction.
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1 month post-intervention
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Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS)
Time Frame: 6 month post-intervention
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The SWLS is a measure of general satisfaction with one's life.
Scores range from 5 to 35 with higher scores indicative of higher life satisfaction.
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6 month post-intervention
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Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5)
Time Frame: 1 month post-intervention
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The WBI-5 measures participants' overall subjective well-being.
Scores range between 0 and 15 with higher scores indicative of greater well-being.
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1 month post-intervention
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Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5)
Time Frame: 6 month post-intervention
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The WBI-5 measures participants' overall subjective well-being.
Scores range between 0 and 15 with higher scores indicative of greater well-being.
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6 month post-intervention
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Perceived Negative Effects of the Intervention Using ad Hoc Questions
Time Frame: 1 month post-intervention
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Two questions were asked from respondents:
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1 month post-intervention
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Perceived Negative Effects of the Intervention Using ad Hoc Questions
Time Frame: 6 month post-intervention
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Two questions were asked from respondents:
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6 month post-intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Barna Konkoly-Thege, PhD, University of Toronto
Publications and helpful links
General Publications
- 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.
- 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.
- Konkoly Thege B, Szabo GS. The efficacy of pandemic-adjusted family/systemic constellation therapy in improving psychopathological symptoms: A randomized controlled trial. J Psychiatr Res. 2024 Sep;177:271-278. doi: 10.1016/j.jpsychires.2024.07.027. Epub 2024 Jul 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BTK/591-1/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The authors are concerned that making individual participant data available to others would seriously jeopardize participants' willingness to participate in the study.
Therefore, the authors offer that they will conduct any alternative analyses on the data set other researchers are interested in and the authors will share the raw output of those analyses including the analytical syntaxes.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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