- 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
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
Genders Eligible for Study
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 |
---|---|
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 |
---|---|---|
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 also includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items.
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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.
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6 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 using an abbreviated, 8-item version of the Screener for Substance and Behavioral Addictions (SSBA-S)
Time Frame: 1 month post-intervention
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The SSBA-S is a short screening instrument for measuring self-attributed addiction problems in the general population.
The SSBA-S is comprised of four self-report item stems, each reflecting a distinct sign or symptom of potentially problematic involvement in either substance-related or behavioral addictions ("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 4 and 28 both for substance-related and behavioral addictions 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 using an abbreviated, 8-item version of the Screener for Substance and Behavioral Addictions (SSBA-S)
Time Frame: 6 month post-intervention
|
The SSBA-S is a short screening instrument for measuring self-attributed addiction problems in the general population.
The SSBA-S is comprised of four self-report item stems, each reflecting a distinct sign or symptom of potentially problematic involvement in either substance-related or behavioral addictions ("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 4 and 28 both for substance-related and behavioral addictions 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 MLQ assesses both the presence of and search for meaning in a respondent's life.
The scale consists of 10 items (5 items measuring both subconstructs).
In both cases, scores range between 5 and 35 but while in the case of presence of meaning, higher scores indicate better functioning; in the case of search for meaning, higher scores are indicative of poorer mental health.
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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
|
The MLQ assesses both the presence of and search for meaning in a respondent's life.
The scale consists of 10 items (5 items measuring both subconstructs).
In both cases, scores range between 5 and 35 but while in the case of presence of meaning, higher scores indicate better functioning; in the case of search for meaning, higher scores are indicative of poorer mental health.
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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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Qualitative responses on the perceived effects of the intervention will also be collected both in terms of positive and negative perceived effects using open ended, ad hoc questions.
Time Frame: 1 month post-intervention
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Four open-ended questions will be asked from respondents, one covering each of the following domains: positive changes in interpersonal life, positive changes in health, negative changes in interpersonal life, and negative changes in health.
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1 month post-intervention
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Qualitative responses on the perceived effects of the intervention will also be collected both in terms of positive and negative perceived effects using open ended, ad hoc questions
Time Frame: 6 month post-intervention
|
Four open-ended questions will be asked from respondents, one covering each of the following domains: positive changes in interpersonal life, positive changes in health, negative changes in interpersonal life, and negative changes in health.
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6 month post-intervention
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Collaborators and Investigators
Collaborators
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.
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 (Actual)
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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