Efficacy of Family Constellations in the General Population

Study Overview
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Brief Summary
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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.

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

Conditions
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Mild to Moderate Psychopathological Symptoms

Intervention / Treatment
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* Behavioral: Family / systemic constellation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Study participants participating in family constellation therapy between assessment 1 and 2. | Behavioral: Family / systemic constellation therapy<br>* 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.<br>|
| No Intervention: Wait-list control group<br>Study participants participating in family constellation therapy only after all 3 assessment points. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Symptom Inventory scores | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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. | 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 | 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 |