Mild to Moderate Psychopathological Symptoms
Conditions
Brief summary
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.
Detailed description
Family/systemic constellation therapy is a system-oriented, short-term group counseling intervention aiming to help clients better understand and resolve their conflicts within their intra- or interpersonal systems, which in turn might lead to a decrease in psychopathological and functional somatic symptoms as well as improvement in overall quality of life. This intervention modality was developed in Germany in the early 1990s integrating elements of - among others - psychodrama, family sculptures, contextual therapy, and certain South-African aboriginal traditions. Compared to its widespread use by therapists of various theoretical and professional backgrounds all over the world, little effort has been made to generate empirical data regarding the efficacy and safety of this intervention and the overall quality and quantity of the extant evidence is low. Authors of the only (although high-quality) previous randomized controlled trial to date into the efficacy of systemic constellations reported that the intervention was efficacious in reducing general, non-diagnosis-specific psychopathology and psychological distress both in the short- as well as middle- and long term. A recent systematic review summarizing both the peer-reviewed and the grey literature on the mental health effects of systemic constellation therapy concluded that further studies into its efficacy and effectiveness are greatly needed, especially if employing 1) a controlled, ideally randomized-controlled design, 2) at least mid-term follow-up (≥6 months) to evaluate client outcomes and 3) active monitoring of potential iatrogenic effects. In line with these recommendations, the aim of the present study - when designed - was to collect and analyze further data on the efficacy of systemic constellation therapy in its traditional format in improving mental health. However, the COVID pandemic required the intervention providers to make substantial changes to the usual treatment protocol; therefore, the study in its final form rather serves the purpose of investigating the efficacy of a pandemic-adjusted version of family/systemic constellation workshops than that of the intervention in general.
Interventions
BEHAVIORALFamily / systemic constellation therapy
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.
Sponsors
University of Toronto
Károli Gáspár University of the Reformed Church in Hungary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Symptom Inventory Scores | 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 includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items, which is used here. The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G | 1 month post-intervention | The SSBA-G (Generalised version of the Screener for Substance and Behavioural Addictions) is comprised of 8 items (4 items assessing substance-related and 4 assessing behavioral addictions). Items reflect a distinct sign or symptom of potentially problematic involvement into an addictive behavior (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 8 and 56 with higher scores indicative of higher problem severity. |
| Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers) | 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. |
| Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ) | 1 month post-intervention | The Presence of Meaning Subscale of the MLQ assesses perceived level of meaningfulness in a respondent's life. The subscale consists of 5 items, and the total scores range between 5 and 35. Higher scores are indicative of better functioning and quality of life. |
| Change in Eating Disorder Risk Assessed by the SCOFF Screening Test | 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. |
| Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5) | 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. |
| Perceived Negative Effects of the Intervention Using ad Hoc Questions | 1 month post-intervention | Two questions were asked from respondents: 1. On the constellation seminar you participated in one month ago or since then, have you experienced any unfavorable change in your family life, your relationships with others or your interpersonal style in general that you attribute to the constellation seminar or can imagine that it is related to your participation in it? 2. On the constellation seminar you participated in one month ago or since then, have you experienced any unfavorable mental or physical change in your personal life that you attribute to the constellation seminar or can imagine that it is related to your participation in it? The number of participants who answered affirmatively to one or both questions above are reported here. Please note that the wording above is a hypersensitive approach to gather data on iatrogenic effects (cf. can imagine that it is related to your participation). |
| Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS) | 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. |
Countries
Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Study participants participating in family constellation therapy between assessment 1 and 2.
Family / systemic constellation therapy: 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. | 36 |
| Wait-list Control Group Study participants participating in family constellation therapy only after all 3 assessment points. | 43 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 8 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention Group | Wait-list Control Group | Total |
|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 8.2 | 42.0 years STANDARD_DEVIATION 9.9 | 42.2 years STANDARD_DEVIATION 9.1 |
| Eating disorder risk assessed by the SCOFF Screening Test | 0.64 scores on a scale STANDARD_DEVIATION 0.93 | 0.75 scores on a scale STANDARD_DEVIATION 1.13 | 0.72 scores on a scale STANDARD_DEVIATION 1.05 |
| General Severity Index of the Brief Symptom Inventory | 0.79 scores on a scale STANDARD_DEVIATION 0.49 | 0.87 scores on a scale STANDARD_DEVIATION 0.68 | 0.83 scores on a scale STANDARD_DEVIATION 0.6 |
| General well-being assessed by the 5-item Version of the WHO Wellbeing Index (WBI-5) | 8.33 scores on a scale STANDARD_DEVIATION 3.13 | 8.98 scores on a scale STANDARD_DEVIATION 3.24 | 8.59 scores on a scale STANDARD_DEVIATION 3.21 |
| Life satisfaction assessed by the Satisfaction With Life Scale (SWLS) | 20.33 scores on a scale STANDARD_DEVIATION 5.17 | 21.33 scores on a scale STANDARD_DEVIATION 7.49 | 21.01 scores on a scale STANDARD_DEVIATION 6.41 |
| Perceived level of meaning in life assessed by the Meaning in Life Questionnaire (MLQ) | 21.03 scores on a scale STANDARD_DEVIATION 7.93 | 24.73 scores on a scale STANDARD_DEVIATION 8.6 | 23.16 scores on a scale STANDARD_DEVIATION 8.35 |
| Quality of life specific to interpersonal relationships assessed by the EXIS.pers | 4.06 scores on a scale STANDARD_DEVIATION 0.77 | 4.24 scores on a scale STANDARD_DEVIATION 0.87 | 4.12 scores on a scale STANDARD_DEVIATION 0.82 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Hungary | 36 participants | 43 participants | 79 participants |
| Sex: Female, Male Female | 24 Participants | 30 Participants | 54 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
| Substance- and behavioral addiction severity assessed by the SSBA-G | 12.97 scores on a scale STANDARD_DEVIATION 5.76 | 16.98 scores on a scale STANDARD_DEVIATION 11.43 | 15.33 scores on a scale STANDARD_DEVIATION 9.73 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 13 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
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 includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items, which is used here. The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity.
Time frame: 1 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Brief Symptom Inventory Scores | 0.61 score on a scale | Standard Deviation 0.36 |
| Wait-list Control Group | Change in Brief Symptom Inventory Scores | 0.71 score on a scale | Standard Deviation 0.68 |
Primary
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, which is used here. The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity.
Time frame: 6 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Brief Symptom Inventory Scores | 0.65 score on a scale | Standard Deviation 0.4 |
| Wait-list Control Group | Change in Brief Symptom Inventory Scores | 0.77 score on a scale | Standard Deviation 0.7 |
Secondary
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.
Time frame: 1 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Eating Disorder Risk Assessed by the SCOFF Screening Test | 0.66 score on a scale | Standard Deviation 0.87 |
| Wait-list Control Group | Change in Eating Disorder Risk Assessed by the SCOFF Screening Test | 0.56 score on a scale | Standard Deviation 0.89 |
Secondary
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.
Time frame: 6 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Eating Disorder Risk Assessed by the SCOFF Screening Test | 0.66 score on a scale | Standard Deviation 0.76 |
| Wait-list Control Group | Change in Eating Disorder Risk Assessed by the SCOFF Screening Test | 0.55 score on a scale | Standard Deviation 0.9 |
Secondary
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.
Time frame: 6 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5) | 8.63 score on a scale | Standard Deviation 2.7 |
| Wait-list Control Group | Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5) | 9.27 score on a scale | Standard Deviation 3.2 |
Secondary
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.
Time frame: 1 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5) | 8.26 score on a scale | Standard Deviation 2.88 |
| Wait-list Control Group | Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5) | 8.62 score on a scale | Standard Deviation 2.58 |
Secondary
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.
Time frame: 6 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS) | 20.83 score on a scale | Standard Deviation 6.85 |
| Wait-list Control Group | Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS) | 23.12 score on a scale | Standard Deviation 7.69 |
Secondary
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.
Time frame: 1 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS) | 20.83 score on a scale | Standard Deviation 5.6 |
| Wait-list Control Group | Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS) | 21.94 score on a scale | Standard Deviation 6.9 |
Secondary
Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)
The Presence of Meaning Subscale of the MLQ assesses perceived level of meaningfulness in a respondent's life. The subscale consists of 5 items, and the total scores range between 5 and 35. Higher scores are indicative of better functioning and quality of life.
Time frame: 1 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ) | 22.51 score on a scale | Standard Deviation 7.28 |
| Wait-list Control Group | Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ) | 26.15 score on a scale | Standard Deviation 8.78 |
Secondary
Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)
The Presence of Meaning Subscale of the MLQ assesses perceived level of meaningfulness in a respondent's life. The subscale consists of 5 items, and the total scores range between 5 and 35. Higher scores are indicative of better functioning and quality of life.
Time frame: 6 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ) | 22.83 score on a scale | Standard Deviation 9.03 |
| Wait-list Control Group | Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ) | 25.55 score on a scale | Standard Deviation 8.48 |
Secondary
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.
Time frame: 6 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers) | 4.20 score on a scale | Standard Deviation 0.84 |
| Wait-list Control Group | Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers) | 4.33 score on a scale | Standard Deviation 0.99 |
Secondary
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.
Time frame: 1 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers) | 4.13 score on a scale | Standard Deviation 0.72 |
| Wait-list Control Group | Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers) | 4.29 score on a scale | Standard Deviation 0.84 |
Secondary
Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G
The SSBA-G (Generalised version of the Screener for Substance and Behavioural Addictions) is comprised of 8 items (4 items assessing substance-related and 4 assessing behavioral addictions). Items reflect a distinct sign or symptom of potentially problematic involvement into an addictive behavior (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 8 and 56 with higher scores indicative of higher problem severity.
Time frame: 6 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G | 12.71 score on a scale | Standard Deviation 7.83 |
| Wait-list Control Group | Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G | 16.39 score on a scale | Standard Deviation 10.97 |
Secondary
Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G
The SSBA-G (Generalised version of the Screener for Substance and Behavioural Addictions) is comprised of 8 items (4 items assessing substance-related and 4 assessing behavioral addictions). Items reflect a distinct sign or symptom of potentially problematic involvement into an addictive behavior (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 8 and 56 with higher scores indicative of higher problem severity.
Time frame: 1 month post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G | 13.83 score on a scale | Standard Deviation 6.48 |
| Wait-list Control Group | Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G | 14.06 score on a scale | Standard Deviation 7.92 |
Secondary
Perceived Negative Effects of the Intervention Using ad Hoc Questions
Two questions were asked from respondents: 1. On the constellation seminar you participated in one month ago or since then, have you experienced any unfavorable change in your family life, your relationships with others or your interpersonal style in general that you attribute to the constellation seminar or can imagine that it is related to your participation in it? 2. On the constellation seminar you participated in one month ago or since then, have you experienced any unfavorable mental or physical change in your personal life that you attribute to the constellation seminar or can imagine that it is related to your participation in it? The number of participants who answered affirmatively to one or both questions above are reported here. Please note that the wording above is a hypersensitive approach to gather data on iatrogenic effects (cf. can imagine that it is related to your participation).
Time frame: 1 month post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Perceived Negative Effects of the Intervention Using ad Hoc Questions | 13 Participants |
Secondary
Perceived Negative Effects of the Intervention Using ad Hoc Questions
Two questions were asked from respondents: 1. In the past 5 months (since the completion of the first follow-up questionnaire of this study), have you experienced any unfavorable change in your family life, your relationships with others or your interpersonal style in general that you attribute to the constellation seminar or can imagine that it is related to your participation in it? 2. In the past 5 months (since the completion of the first follow-up questionnaire of this study), have you experienced any unfavorable mental or physical change in your personal life that you attribute to the constellation seminar or can imagine that it is related to your participation in it? The number of participants who answered affirmatively to one or both questions above are reported here. Please note that the wording above is a hypersensitive approach to gather data on iatrogenic effects (cf. can imagine that it is related to your participation).
Time frame: 6 month post-intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Perceived Negative Effects of the Intervention Using ad Hoc Questions | 9 Participants |