Trial Outcomes & Findings for The Psychosocial Effects of Systemic / Family Constellation (NCT NCT03233958)

NCT ID: NCT03233958

Last Updated: 2025-04-15

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 182 participants
• Primary outcome timeframe: Before, 1- and 6-month after the intervention
• Results posted on: 2025-04-15

Participant Flow

Participant milestones

Measure	Family Constellation Participants Participants of systemic / family constellation workshops
Overall Study STARTED	182
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	80

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Workshop Participants n=182 Participants Participants of systemic / family constellation workshops Systemic / 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 \[Hunger, Weinhold, Bornhäuser, Link, \& Schweitzer, 2015\].
Age, Continuous	39.9 years STANDARD_DEVIATION 9.5 • n=182 Participants
Sex: Female, Male Female	152 Participants n=182 Participants
Sex: Female, Male Male	30 Participants n=182 Participants
Region of Enrollment Hungary	182 Participants n=182 Participants
General Severity Index of the Brief Symptom Inventory	0.89 units on a scale STANDARD_DEVIATION 0.54 • n=182 Participants

PRIMARY outcome

Timeframe: Before, 1- and 6-month after the intervention

Population: Participants completing both the baseline and the one- and 6-month follow-up questionnaire.

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).

Outcome measures

Measure	Family Constellation Participants n=102 Participants Participants of systemic / family constellation workshops
Change in General Severity Index Scores on the Brief Symptom Inventory 6-month postintervention	0.58 score on a scale Standard Deviation 0.53
Change in General Severity Index Scores on the Brief Symptom Inventory Baseline	0.82 score on a scale Standard Deviation 0.51
Change in General Severity Index Scores on the Brief Symptom Inventory 1-month postintervention	0.56 score on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: Before, 1 month after and 6 months after the intervention

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.

Outcome measures

Measure	Family Constellation Participants n=102 Participants Participants of systemic / family constellation workshops
Change in Scores on the Experience in Personal Social Systems Questionnaire Baseline	44.97 score on a scale Standard Deviation 11.33
Change in Scores on the Experience in Personal Social Systems Questionnaire 1-month postintervention	49.67 score on a scale Standard Deviation 13.76
Change in Scores on the Experience in Personal Social Systems Questionnaire 6-month postintervention	50.52 score on a scale Standard Deviation 13.42

SECONDARY outcome

Timeframe: Before, 1 month after and 6 months after the intervention

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).

Outcome measures

Measure	Family Constellation Participants n=102 Participants Participants of systemic / family constellation workshops
Change in Scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15) Baseline	6.89 score on a scale Standard Deviation 4.26
Change in Scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15) 1-month postintervention	5.55 score on a scale Standard Deviation 4.33
Change in Scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15) 6-month postintervention	6.35 score on a scale Standard Deviation 4.71

SECONDARY outcome

Timeframe: Before, 1 month after and 6 months after the intervention

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.

Outcome measures

Measure	Family Constellation Participants n=102 Participants Participants of systemic / family constellation workshops
Change in Scores on the SCOFF Questionnaire Baseline	0.65 score on a scale Standard Deviation 1.00
Change in Scores on the SCOFF Questionnaire 1-month postintervention	0.55 score on a scale Standard Deviation 0.91
Change in Scores on the SCOFF Questionnaire 6-months postintervention	0.47 score on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: Before, 1 month after and 6 months after the intervention

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.

Outcome measures

Measure	Family Constellation Participants n=102 Participants Participants of systemic / family constellation workshops
Change in Scores on ad Hoc Items to Assess Behavioral and Substance-related Addictions 6-month postintervention	6.22 score on a scale Standard Deviation 2.65
Change in Scores on ad Hoc Items to Assess Behavioral and Substance-related Addictions Baseline	6.73 score on a scale Standard Deviation 3.10
Change in Scores on ad Hoc Items to Assess Behavioral and Substance-related Addictions 1-month postintervention	6.35 score on a scale Standard Deviation 2.43

SECONDARY outcome

Timeframe: Before, 1 month after and 6 months after the intervention

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).

Outcome measures

Measure	Family Constellation Participants n=102 Participants Participants of systemic / family constellation workshops
Change in Scores on the Meaning in Life Questionnaire / Presence of Meaning Subscale Baseline	22.87 score on a scale Standard Deviation 8.37
Change in Scores on the Meaning in Life Questionnaire / Presence of Meaning Subscale 1-month postintervention	23.79 score on a scale Standard Deviation 8.95
Change in Scores on the Meaning in Life Questionnaire / Presence of Meaning Subscale 6-month postintervention	23.94 score on a scale Standard Deviation 8.44

SECONDARY outcome

Timeframe: Before, 1 month after and 6 months after the intervention

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.

Outcome measures

Measure	Family Constellation Participants n=102 Participants Participants of systemic / family constellation workshops
Change in Scores on the World Health Organization Wellbeing Index (WBI-5) 6-months postintervention	9.26 score on a scale Standard Deviation 3.46
Change in Scores on the World Health Organization Wellbeing Index (WBI-5) Baseline	8.01 score on a scale Standard Deviation 3.27
Change in Scores on the World Health Organization Wellbeing Index (WBI-5) 1-month postintervention	9.10 score on a scale Standard Deviation 3.29

SECONDARY outcome

Timeframe: 1 month after and 6 months after the intervention

Qualitative responses on the perceived iatrogenic effects of the intervention were collected using-open ended, ad hoc questions.

Outcome measures

Measure	Family Constellation Participants n=102 Participants Participants of systemic / family constellation workshops
Participant-perceived Iatrogenic Effects 1 month	11 Participants
Participant-perceived Iatrogenic Effects 6 months	17 Participants

Adverse Events

Workshop Participants

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Workshop Participants n=102 participants at risk Participants of systemic / family constellation workshops
Psychiatric disorders Negative mental health outcomes	6.9% 7/102 • Number of events 7 • 6 months postintervention 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.
Endocrine disorders Negative physical health outcomes	7.8% 8/102 • Number of events 8 • 6 months postintervention 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.
Psychiatric disorders Combined mental and physical negative outcomes	2.0% 2/102 • Number of events 2 • 6 months postintervention 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.

Additional Information

Barna Konkoly-Thege

University of Toronto

Phone: +1 (705) 549 3181

Email: konkoly.thege.barna@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place