Mild to Moderate Psychopathological Symptoms Clinical Trial
Official title:
Efficacy of Family / Systemic Constellation Therapy in the General Population. A Randomized Wait-list Controlled Trial
| Verified date | August 2022 |
| Source | Károli Gáspár University of the Reformed Church in Hungary |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | April 25, 2022 |
| Est. primary completion date | April 25, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Károli Gáspár University of the Reformed Church in Hungary | Budapest |
| Lead Sponsor | Collaborator |
|---|---|
| Károli Gáspár University of the Reformed Church in Hungary | University of Toronto |
Hungary,
Konkolÿ 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. — View Citation
Weinhold J, Hunger C, Bornhäuser 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 1 month post-intervention | |
| 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. | 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. | 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. | 6 month post-intervention | |
| Secondary | 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 | |
| Secondary | 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 | |
| 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. | 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. | 6 month post-intervention | |
| Secondary | 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 | |
| Secondary | 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 | |
| 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. | 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. | 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. | 1 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. | 6 month post-intervention | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03233958 -
The Psychosocial Effects of Systemic / Family Constellation
|