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NCT Number: NCT05051462

Efficacy of Family Constellations in the General Population

The purpose of this study is to investigate the efficacy of systemic / family constellation therapy in improving mild-moderate psychopathological symptoms and overall wellbeing in the general population. Given the limited amount of evidence on this therapeutic method, special attention will be given to monitor potential adverse outcomes to establish intervention safety. The study will use a randomized, wait-list controlled design and a 6-month follow-up time. This is the second study of this nature following a similar study from Germany.

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Key information

Conditions

Mild to Moderate Psychopathological Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Károli Gáspár University of the Reformed Church in Hungary

Budapest, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family / systemic constellation therapy

Behavioral

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.

Primary outcomes

  1. Change in Brief Symptom Inventory Scores

    Time frame: 1 month post-intervention

    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.

  2. Change in Brief Symptom Inventory Scores

    Time frame: 6 month post-intervention

    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.

Secondary outcomes

  1. Change in Eating Disorder Risk Assessed by the SCOFF Screening Test

    Time frame: 1 month post-intervention

    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.

  2. Change in Eating Disorder Risk Assessed by the SCOFF Screening Test

    Time frame: 6 month post-intervention

    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.

  3. Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G

    Time frame: 1 month post-intervention

    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.

  4. Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G

    Time frame: 6 month post-intervention

    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.

  5. 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

    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.

  6. 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

    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.

  7. Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)

    Time frame: 1 month post-intervention

    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.

  8. Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)

    Time frame: 6 month post-intervention

    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.

  9. Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS)

    Time frame: 1 month post-intervention

    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.

  10. Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS)

    Time frame: 6 month post-intervention

    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.

  11. Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5)

    Time frame: 1 month post-intervention

    The WBI-5 measures participants' overall subjective well-being. Scores range between 0 and 15 with higher scores indicative of greater well-being.

  12. Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5)

    Time frame: 6 month post-intervention

    The WBI-5 measures participants' overall subjective well-being. Scores range between 0 and 15 with higher scores indicative of greater well-being.

  13. Perceived Negative Effects of the Intervention Using ad Hoc Questions

    Time frame: 1 month post-intervention

    Two questions were asked from respondents:

    • "On the constellation seminar you participated in one month ago or since then, have you experienced any unfavorable change in your family life, your relationships with others or your interpersonal style in general that you attribute to the constellation seminar or can imagine that it is related to your participation in it?"
    • "On the constellation seminar you participated in one month ago or since then, have you experienced any unfavorable mental or physical change in your personal life that you attribute to the constellation seminar or can imagine that it is related to your participation in it?" The number of participants who answered affirmatively to one or both questions above are reported here. Please note that the wording above is a hypersensitive approach to gather data on iatrogenic effects (cf. "can imagine that it is related to your participation").

  14. Perceived Negative Effects of the Intervention Using ad Hoc Questions

    Time frame: 6 month post-intervention

    Two questions were asked from respondents:

    • "In the past 5 months (since the completion of the first follow-up questionnaire of this study), have you experienced any unfavorable change in your family life, your relationships with others or your interpersonal style in general that you attribute to the constellation seminar or can imagine that it is related to your participation in it?"
    • "In the past 5 months (since the completion of the first follow-up questionnaire of this study), have you experienced any unfavorable mental or physical change in your personal life that you attribute to the constellation seminar or can imagine that it is related to your participation in it?" The number of participants who answered affirmatively to one or both questions above are reported here. Please note that the wording above is a hypersensitive approach to gather data on iatrogenic effects (cf. "can imagine that it is related to your participation").

Sponsors and collaborators

Lead sponsor

Károli Gáspár University of the Reformed Church in Hungary

Other

Collaborators

  • University of Toronto

Registry information

Official study title

Efficacy of Family / Systemic Constellation Therapy in the General Population. A Randomized Wait-list Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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