Psychological Well-beingPhase 2/3NCT01352325
Efficacy of System Constellations in a General Population
A Phase 2/3 study testing system constellations seminar in people with Psychological Well-being, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the efficacy of system constellations in a monocentric, single-masked randomized controlled trial. The method of system constellations refers to an approach which integrates ideas from family systems therapy with elements from psychodrama. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-being
- What is being tested?
- system constellations seminar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Dec 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- agreement to participate in a 3-day system constellations seminar
- agreement to be randomized into treatment group or control group (waiting condition)
- agreement not to participate in another system constellation seminar until completion of study
Who cannot join
- acute suicidal tendency
- acute psychotic episode
- acute drug or alcohol intoxication
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Psychology, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69115
About this study
Official title: Randomized Controlled Trial on the Efficacy of System Constellations on Psychological Well-being in a General Population Based Sample
The purpose of this study is to investigate the efficacy of system constellations in a monocentric, single-masked randomized controlled trial.
The method of system constellations 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 three days.
Based on the model of a general psychotherapy and the consistency theory, the effects of system constellations on psychological functioning are explored.
It is predicted that participation in a system constellation seminar changes the level of psychological functioning at 4 months.
- Conditions
- Psychological Well-being
- Being tested
- system constellations seminar
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
system constellations seminarBehavioural
individual-centered intervention in a group setting, duration 3 days
system constellations seminarBehavioural
individual-centered intervention in a group setting, duration 3 days
| Study group | Role | What they receive |
|---|---|---|
| system constellations seminar (exp. group) | Experimental | Study participants randomized to this group receive the intervention (system constellation seminar) 4 months prior to the control group Receives: Behavioral: system constellations seminar |
| system constellations seminar (control group) | Experimental | Study participants randomized to this group receive the intervention (system constellations seminar) 4 months after the experimental group. Receives: Behavioral: system constellations seminar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in psychological well-being at 2 weeks and four months
Psychological well-being will be assessed using the 'Outcome Questionnaire' in its German version (EB-45). The EB-45 is a brief 45-item self report outcome/tracking instrument designed for repeated measurement of client progress through the course of psychotherapy and following termination. The scales of the EB-45 measure symptom distress, interpersonal functioning, and social role.
Measured: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Secondary outcomes (4)
Change from Baseline in Psychological distress after 2 weeks and 4 months
The FEP-2, 40-item self report questionnaire, measures psychological distress according to the phase model of therapeutic change as well as the interpersonal model of psychological distress.
Measured: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Change from Baseline in Incongruence at 2 weeks and 4 months
Motivational incongruence is defined as the unsatisfactory realization of motivational goals and is based on the concept of General Psychotherapy by Klaus Grawe. The Incongruence Questionnaire (INK) is an instrument that assesses motivational incongruence, defined as the discrepancy between a person's motivational goals and his/her perception of reality. The short version of this questionnaire that will be used in our study (K-INK) comprises 23 items.
Measured: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Goal achievement at 2 weeks and 4 months
Goal achievement will be assessed using Goal Attainment Scaling as a method for the assimilation of achievement in a number of individually set goals into a single aggregated 'goal attainment score', providing a person-centred outcome, focused on that individual's priorities. Goal attainment scaling is operationalized by an open-ended question, in which study participants descriobe their individual goals. In a second step these goals will be coded according to the Bern inventory of psychotherapy goals (BIT-C).
Measured: day of treatment, 2 weeks after treatment, 4 months after treatment
Change from Baseline in 'Experiences in family and organisational systems' at 2 weeks and 4 months
The subjective quality of family and organizational systems will be assessed by the HFES (Heidelberger Fragebogen zum Erleben in Systemen: Heidelberg Questionnaire on experiences in systems), a self-constructed questionnaire comprising 24 items.
Measured: day of treatment, 2 weeks after treatment, 4 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jochen Schweitzer-Rothers, Heidelberg University
- Investigators
- Jochen Schweitzer-Rothers, Professor, Study director, Institute of Medical Psychology, University Hospital Heidelberg/Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352325
- Sponsor's protocol ID
- SFBC11
- Other IDs
- SFB 619 project C11
- Status last verified
- Feb 2012
- First submitted
- 4 May 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hunger C, Bornhauser 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.
PubMed 24251855
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Efficacy of System Constellations on Psychological Well-being in a General Population Based Sample
- ClinicalTrials.gov ID
- NCT01352325
- Acronym / sponsor ID
- SFBC11
- Conditions
- Psychological Well-being
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of system constellations in a monocentric, single-masked randomized controlled trial.
The method of system constellations 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 three days.
Based on the model of a general psychotherapy and the consistency theory, the effects of system constellations on psychological functioning are explored.
It is predicted that participation in a system constellation seminar changes the level of psychological functioning at 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| system constellations seminar (exp. group) | Experimental | Behavioral: system constellations seminarStudy participants randomized to this group receive the intervention (system constellation seminar) 4 months prior to the control group |
| system constellations seminar (control group) | Experimental | Behavioral: system constellations seminarStudy participants randomized to this group receive the intervention (system constellations seminar) 4 months after the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- agreement to participate in a 3-day system constellations seminar
- agreement to be randomized into treatment group or control group (waiting condition)
- agreement not to participate in another system constellation seminar until completion of study
Key exclusion criteria (3 listed)
- acute suicidal tendency
- acute psychotic episode
- acute drug or alcohol intoxication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| system constellations seminarindividual-centered intervention in a group setting, duration 3 days | Behavioural | system constellations seminar (exp. group) |
| system constellations seminarindividual-centered intervention in a group setting, duration 3 days | Behavioural | system constellations seminar (control group) |
Primary outcome
Change from Baseline in psychological well-being at 2 weeks and four months
Time frame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Psychological well-being will be assessed using the 'Outcome Questionnaire' in its German version (EB-45). The EB-45 is a brief 45-item self report outcome/tracking instrument designed for repeated measurement of client progress through the course of psychotherapy and following termination. The scales of the EB-45 measure symptom distress, interpersonal functioning, and social role.
4 secondary outcomes
Change from Baseline in Psychological distress after 2 weeks and 4 months
Time frame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Change from Baseline in Incongruence at 2 weeks and 4 months
Time frame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment
Goal achievement at 2 weeks and 4 months
Time frame: day of treatment, 2 weeks after treatment, 4 months after treatment
Change from Baseline in 'Experiences in family and organisational systems' at 2 weeks and 4 months
Time frame: day of treatment, 2 weeks after treatment, 4 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- Derived from this study: PubMed 24251855Hunger C, Bornhauser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Schweitzer-Rothers, Professor study director
Institute of Medical Psychology, University Hospital Heidelberg/Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing system constellations seminar in people with Psychological Well-being, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in psychological well-being at 2 weeks and four months (time frame: Baseline, day of treatment, 2 weeks after treatment, 4 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01352325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.