Mild to Moderate Psychopathological SymptomsNCT03233958
The Psychosocial Effects of Systemic / Family Constellation
An observational study of Mild to Moderate Psychopathological Symptoms, run by Károli Gáspár University of the Reformed Church in Hungary at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Psychopathological Symptoms
- What is being tested?
- Systemic / family constellation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 182 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jul 2017to 30 Oct 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals from the general population who seek help through family constellation seminars for various mild to moderate psychological symptoms.
Who may be able to join
- 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
Who cannot join
- Age under 18 years
- Currently suffers from a diagnosed mental disorder
- Participated actively (not merely as a "representative") in a family constellation intervention in the 12 months preceding baseline assessment
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Károli Gáspár University of the Reformed Church in Hungary
Budapest, 1037
About this study
Official title: The Psychosocial Effects of Systemic / Family Constellation: An Observational Follow-up Study
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.
Read the detailed description
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.
We 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.
The 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).
Regardless 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).
The 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.
- Being tested
- Systemic / family constellation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic / family constellationBehavioural
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].
| Study group | Role | What they receive |
|---|---|---|
| Workshop participants | Participants of systemic / family constellation workshops Receives: Behavioral: Systemic / family constellation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General Severity Index Scores on the Brief Symptom Inventory
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).
Measured: Before, 1- and 6-month after the intervention
Secondary outcomes (7)
Change in Scores on the Experience in Personal Social Systems Questionnaire
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.
Measured: Before, 1 month after and 6 months after the intervention
Change in Scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15)
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).
Measured: Before, 1 month after and 6 months after the intervention
Change in Scores on the SCOFF Questionnaire
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.
Measured: Before, 1 month after and 6 months after the intervention
Change in Scores on ad Hoc Items to Assess Behavioral and Substance-related Addictions
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.
Measured: Before, 1 month after and 6 months after the intervention
Change in Scores on the Meaning in Life Questionnaire / Presence of Meaning Subscale
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).
Measured: Before, 1 month after and 6 months after the intervention
Change in Scores on the World Health Organization Wellbeing Index (WBI-5)
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.
Measured: Before, 1 month after and 6 months after the intervention
Participant-perceived Iatrogenic Effects
Qualitative responses on the perceived iatrogenic effects of the intervention were collected using-open ended, ad hoc questions.
Measured: 1 month after and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Jul 2017
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Psychopathological SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Károli Gáspár University of the Reformed Church in Hungary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Gergely Sándor Szabó, PhD, Károli Gáspár University of the Reformed Church in Hungary
- Investigators
- Barna Konkoly Thege, PhD, Study director, Department of Psychiatry, Univeristy of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233958
- Sponsor's protocol ID
- 325/2017/P
- Status last verified
- Apr 2025
- First submitted
- 25 Jul 2017
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 23957767Hunger 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.
PubMed 25264190Hunger 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.
PubMed 24251855Konkoly 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.
PubMed 33528854Konkoly 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.
PubMed 36256988
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychosocial Effects of Systemic / Family Constellation: An Observational Follow-up Study
- ClinicalTrials.gov ID
- NCT03233958
- Acronym / sponsor ID
- 325/2017/P
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Károli Gáspár University of the Reformed Church in HungaryUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
We 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.
The 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).
Regardless 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).
The 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Workshop participants | – | Behavioral: Systemic / family constellationParticipants of systemic / family constellation workshops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals from the general population who seek help through family constellation seminars for various mild to moderate psychological symptoms.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 18 years
- Currently suffers from a diagnosed mental disorder
- Participated actively (not merely as a "representative") in a family constellation intervention in the 12 months preceding baseline assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic / family constellationSystemic / 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]. | Behavioural | Workshop participants |
Primary outcome
Change in General Severity Index Scores on the Brief Symptom Inventory
Time frame: Before, 1- and 6-month after the intervention
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).
7 secondary outcomes
Change in Scores on the Experience in Personal Social Systems Questionnaire
Time frame: Before, 1 month after and 6 months after the intervention
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
Change in Scores on the SCOFF Questionnaire
Time frame: Before, 1 month after and 6 months after the intervention
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
Change in Scores on the Meaning in Life Questionnaire / Presence of Meaning Subscale
Time frame: Before, 1 month after and 6 months after the intervention
Change in Scores on the World Health Organization Wellbeing Index (WBI-5)
Time frame: Before, 1 month after and 6 months after the intervention
Participant-perceived Iatrogenic Effects
Time frame: 1 month after and 6 months after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23957767Weinhold 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.
- Background: PubMed 25264190Hunger 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.
- Background: PubMed 24251855Hunger 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.
- Background: PubMed 33528854Konkoly 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.
- Results publication: PubMed 36256988Konkoly 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.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barna Konkoly Thege, PhD study director
Department of Psychiatry, Univeristy of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild to Moderate Psychopathological Symptoms, run by Károli Gáspár University of the Reformed Church in Hungary at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in General Severity Index Scores on the Brief Symptom Inventory (time frame: Before, 1- and 6-month after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03233958, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.