Mild to Moderate Psychopathological Symptoms Clinical Trial
Official title:
The Psychosocial Effects of Systemic / Family Constellation: An Observational Follow-up Study
NCT number | NCT03233958 |
Other study ID # | 325/2017/P |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | October 30, 2020 |
Verified date | February 2021 |
Source | Károli Gáspár University of the Reformed Church in Hungary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to investigate the psychosocial effects of systemic / family constellation. The method of systemic / family constellation refers to an approach which integrates ideas from family systems therapy with elements from psychodrama. The constellations are conducted in a group based seminar-setting, each seminar lasting two days. Considering the very limited amount of empirical data on this method, the study design is a simple pre-post one with a 6-months follow-up. The study will be observational: the researchers will not manipulate who receives the intervention; instead they invite all clients (individuals from the general population) attending these therapeutic workshops run independently of the research process. Given the limited amount of evidence on this therapeutic method, special attention will be given to monitor potential adverse outcomes to establish intervention safety. It is hypothesized that participation in a family constellation seminar might decrease potential psychological symptoms and will not result in adverse outcomes.
Status | Completed |
Enrollment | 182 |
Est. completion date | October 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Self-referred and registered for a family constellation workshop with one of the therapists (clinical psychologist / psychiatrist) who were willing to collaborate with the researchers of the present study Exclusion Criteria: - Age under 18 years - Currently suffers from a diagnosed mental disorder - Participated actively (not merely as a "representative") in a family constellation intervention in the 12 months preceding baseline assessment |
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,
Hunger C, Bornhäuser A, Link L, Schweitzer J, Weinhold J. Improving experience in personal social systems through family constellation seminars: results of a randomized controlled trial. Fam Process. 2014 Jun;53(2):288-306. doi: 10.1111/famp.12051. Epub 2013 Nov 19. — View Citation
Hunger C, Weinhold J, Bornhäuser A, Link L, Schweitzer J. Mid- and long-term effects of family constellation seminars in a general population sample: 8- and 12-month follow-up. Fam Process. 2015 Jun;54(2):344-58. doi: 10.1111/famp.12102. Epub 2014 Sep 29. — View Citation
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 Feb 2. doi: 10.1111/famp.12636. [Epub ahead of print] — 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 scores on the Brief Symptom Inventory | A broad spectrum of psychopathological symptoms including somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism | Before, 1 month after and 6 months after the intervention | |
Primary | Change in answers to ad hoc items developed for qualitative analysis | These items are developed by the study authors to 1) screen for any potential adverse outcomes as a result of the intervention, 2) better understand the treatment goals of individuals participating in this form of therapy and how these relate to what they perceive as the outcome of the intervention | 1 and 6 months after the intervention | |
Secondary | Change in scores on the Experience in Personal Social Systems Questionnaire | Assessment of how the members of a personal social system experience their situation within that system. | Before, 1 month after and 6 months after the intervention | |
Secondary | Change in scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15) | The PHQ-15 includes 15 somatic symptoms (headache, stomach pain, chest pain, dizziness, etc.) that account for more than 90% of symptoms seen in primary care (exclusive of upper respiratory symptoms) | Before, 1 month after and 6 months after the intervention | |
Secondary | Change in scores on the SCOFF | The SCOFF is a brief screener to detect increased risk for eating disorders | Before, 1 month after and 6 months after the intervention | |
Secondary | Change in scores on ad hoc items to assess behavioral and substance-related addictions | Items assess perceived problem severity with addictions | Before, 1 month after and 6 months after the intervention | |
Secondary | Change in scores on the Meaning in Life Questionnaire (MLQ) | The MLQ assesses the perceived level of the presence and search for meaning in an individual's life | Before, 1 month after and 6 months after the intervention | |
Secondary | Change in scores on the World Health Organization Wellbeing Index (WBI-5) | The WBI-5 captures the general well-being of the individuals | Before, 1 month after and 6 months after the intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05051462 -
Efficacy of Family Constellations in the General Population
|
N/A |