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The Psychosocial Effects of Systemic / Family Constellation

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ClinicalTrials.gov Identifier: NCT03233958
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Gergely Sándor Szabó, PhD, Károli Gáspár University of the Reformed Church in Hungary

Tracking Information
First Submitted Date July 25, 2017
First Posted Date July 31, 2017
Last Update Posted Date February 25, 2020
Actual Study Start Date July 1, 2017
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2017)
  • Change in scores on the Brief Symptom Inventory [ Time Frame: Before, 1 month after and 6 months after the intervention ]
    A broad spectrum of psychopathological symptoms including somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism
  • Change in answers to ad hoc items developed for qualitative analysis [ Time Frame: 1 and 6 months after the intervention ]
    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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 27, 2017)
  • Change in scores on the Experience in Personal Social Systems Questionnaire [ Time Frame: Before, 1 month after and 6 months after the intervention ]
    Assessment of how the members of a personal social system experience their situation within that system.
  • Change in scores on the Patient Health Questionnaire Somatic Symptom Severity Scale (PHQ-15) [ Time Frame: Before, 1 month after and 6 months after the intervention ]
    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)
  • Change in scores on the SCOFF [ Time Frame: Before, 1 month after and 6 months after the intervention ]
    The SCOFF is a brief screener to detect increased risk for eating disorders
  • Change in scores on ad hoc items to assess behavioral and substance-related addictions [ Time Frame: Before, 1 month after and 6 months after the intervention ]
    Items assess perceived problem severity with addictions
  • Change in scores on the Meaning in Life Questionnaire (MLQ) [ Time Frame: Before, 1 month after and 6 months after the intervention ]
    The MLQ assesses the perceived level of the presence and search for meaning in an individual's life
  • Change in scores on the World Health Organization Wellbeing Index (WBI-5) [ Time Frame: Before, 1 month after and 6 months after the intervention ]
    The WBI-5 captures the general well-being of the individuals
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Psychosocial Effects of Systemic / Family Constellation
Official Title The Psychosocial Effects of Systemic / Family Constellation: An Observational Follow-up Study
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals from the general population who seek help through family constellation seminars for various mild to moderate psychological symptoms.
Condition Mild to Moderate Psychopathological Symptoms
Intervention Behavioral: Systemic / family constellation
Systemic / family constellation integrates elements from psychodrama, family sculpture, and spontaneous dramatizations of intra- and interpersonal processes, while spatially visualizing family dynamics. Family constellations stimulate change through the following ways: 1) making visible the spatial arrangement of relationships within a conflictual system; 2) providing access to the insights of unrelated third parties regarding the sensations, feelings, and thoughts they experienced while representing family members within the constellation; and 3) making observable (from the outside) and experienceable (from within) the transformation of the problem constellation into the solution constellation [Hunger, Weinhold, Bornhäuser, Link, & Schweitzer, 2015].
Study Groups/Cohorts Workshop participants
Participants of systemic / family constellation workshops
Intervention: Behavioral: Systemic / family constellation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 27, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Gergely S Szabó, PhD +36(30)558-1857 gergely.szabo.psy@gmail.com
Contact: Barna Konkoly Thege, PhD +1(705)549-3181 ext 2614 konkoly.thege.barna@gmail.com
Listed Location Countries Hungary
Removed Location Countries  
 
Administrative Information
NCT Number NCT03233958
Other Study ID Numbers 325/2017/P
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: The investigators have not requested permission from their study participants to make their data available to others to increase participants' sense of confidentiality and so willingness to participate in the study. As a consequence, in case of a data sharing request, the investigators would have to seek for additional explicit permission from the participants. As the investigators have committed to destroy participant contact data after finishing the study, the chances of such data sharing seem slim. However, the investigators are more than happy to conduct alternative analyses based on interested colleagues' suggestions / inquiry and share the raw output (including analytic syntax) of such analyses with those making the inquiry.
Responsible Party Gergely Sándor Szabó, PhD, Károli Gáspár University of the Reformed Church in Hungary
Study Sponsor Károli Gáspár University of the Reformed Church in Hungary
Collaborators University of Toronto
Investigators
Study Director: Barna Konkoly Thege, PhD Department of Psychiatry, Univeristy of Toronto
PRS Account Károli Gáspár University of the Reformed Church in Hungary
Verification Date February 2020