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| Name | Class |
|---|---|
| University of Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Study participants participating in family constellation therapy between assessment 1 and 2. |
|
| Wait-list control group | No Intervention | Study participants participating in family constellation therapy only after all 3 assessment points. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family / systemic constellation therapy | Behavioral | 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. |
| 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 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. | 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, which is used here. The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity. | 6 month post-intervention |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barna Konkoly-Thege, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Károli Gáspár University of the Reformed Church in Hungary | Budapest | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33528854 | Background | 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. | |
| 23957767 | Background | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Wait-list Control Group | Study participants participating in family constellation therapy only after all 3 assessment points. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month post-intervention |
|
1 month post-intervention
Data on adverse events in the waitlist control group were unfortunately not collected due to a design flaw of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Interpersonal relationships | Social circumstances | Non-systematic Assessment | Any unfavorable change in family life, relationships with others or interpersonal style in general |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barna Konkoly-Thege | University of Toronto | +1 (705) 549 3181 | 2614 | konkoly.thege.barna@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 25, 2021 | Dec 5, 2024 | Prot_SAP_ICF_000.pdf |
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|
| 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 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. | 1 month post-intervention |
| 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. | 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 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. | 1 month post-intervention |
| 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. | 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 |
| Perceived Negative Effects of the Intervention Using ad Hoc Questions | Two questions were asked from respondents:
| 1 month post-intervention |
| Perceived Negative Effects of the Intervention Using ad Hoc Questions | Two questions were asked from respondents:
| 6 month post-intervention |
| 39053295 | Result | Konkoly Thege B, Szabo GS. The efficacy of pandemic-adjusted family/systemic constellation therapy in improving psychopathological symptoms: A randomized controlled trial. J Psychiatr Res. 2024 Sep;177:271-278. doi: 10.1016/j.jpsychires.2024.07.027. Epub 2024 Jul 18. |
| Protocol Violation |
|
| BG001 | Wait-list Control Group | Study participants participating in family constellation therapy only after all 3 assessment points. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| General Severity Index of the Brief Symptom Inventory | 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. | Mean | Standard Deviation | scores on a scale |
|
| 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. | Mean | Standard Deviation | scores on a scale |
|
| 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. | Mean | Standard Deviation | scores on a scale |
|
| Quality of life specific to interpersonal relationships assessed by the 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. | Mean | Standard Deviation | scores on a scale |
|
| Perceived level of meaning in life assessed by 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. | Mean | Standard Deviation | scores on a scale |
|
| Life satisfaction assessed by 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. | Mean | Standard Deviation | scores on a scale |
|
| General well-being assessed by 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. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | Wait-list Control Group | Study participants participating in family constellation therapy only after all 3 assessment points. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month post-intervention |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month post-intervention |
|
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month post-intervention |
|
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| Secondary | Perceived Negative Effects of the Intervention Using ad Hoc Questions | Two questions were asked from respondents:
| Posted | Count of Participants | Participants | 1 month post-intervention |
|
|
|
| Secondary | Perceived Negative Effects of the Intervention Using ad Hoc Questions | Two questions were asked from respondents:
| Posted | Count of Participants | Participants | 6 month post-intervention |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 13 |
| 35 |
|
| Any mild physical or mental health concern | General disorders | Non-systematic Assessment | Unfavorable mental or physical health change |
|
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