Efficacy of Family Constellations in the General Population

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Budapest, Hungary
        • Károli Gáspár University of the Reformed Church in Hungary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
No Intervention: Wait-list control group
Study participants participating in family constellation therapy only after all 3 assessment points.

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.
1 month post-intervention
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.
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
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.
6 month post-intervention
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
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.
1 month post-intervention
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.
6 month post-intervention
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.
1 month post-intervention
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.
6 month post-intervention
Change in perceived level of meaning in life using the Meaning in Life Questionnaire (MLQ)
Time Frame: 1 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.
1 month post-intervention
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.
6 month post-intervention
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.
1 month post-intervention
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.
6 month post-intervention
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.
1 month post-intervention
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.
6 month post-intervention
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
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.
1 month post-intervention
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.
6 month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Actual)

April 25, 2022

Study Completion (Actual)

April 25, 2022

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

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)?

NO

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

No

Studies a U.S. FDA-regulated device product

No

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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