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SNCTP000001562 | ISRCTN11198115

Psychologische Mechanismen zur Lösung von Annäherungs-Vermeidungs-Konflikt - eine Verhaltensstudie

Data source: BASEC (Imported from 26.04.2024), WHO (Imported from 25.04.2024)
Changed: Oct 13, 2019, 2:00 AM
Disease category: Other

Brief description of trial (Data source: BASEC)

Angst ist ein häufiges Symptom psychiatrischer Erkrankungen. Heutige pharmakologische Behandlungen beruhen auf Tiermodellen zum Annäherungs-Vermeidungs-Konflikt, die beim Menschen bisher nicht untersucht wurden. Mit Annäherungs-Vermeidungs-Konflikt bezeichnet man Situationen, in denen ein Tier oder Mensch eine bestimmte Situation gleichzeitig annähern und vermeiden sollte, zum Beispiel weil in der gleichen Situation sowohl Belohnung als auch Bestrafung möglich ist. In dieser Studie soll menschliches Verhalten in einem Computerspiel untersuchen werden, in denen ein Annäherungs-Vermeidungs-Konflikt besteht. Insgesamt dauert die Studie 4 Jahre, und es sollen in Zürich 600 Personen eingeschlossen werden. Die Studie wird nur in Zürich durchgeführt.  Wir machen diese Studie so, wie es die Gesetze in der Schweiz vorschreiben. Ausserdem beachten wir alle international anerkannten Richtlinien. Die zuständige Kantonale Ethikkommission hat die Studie geprüft und bewilligt.

Health conditions investigated(Data source: BASEC)

Wir untersuchen, wie der Annäherungs- Vermeidungs-Konflikt in einem Computerspiel gelöst wird. Dazu werden wir Reaktionszeiten und Entscheidungen aufzeichnen.

Health conditions (Data source: WHO)

Basic psychological mechanisms of resolving goal conflict
Mental and Behavioural Disorders
Basic psychological mechanisms of resolving goal conflict

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Hautleitreaktion, EKG, Gesichts-EMG, Atmung, elektrische Stimulation, Computerspiel.

Interventions (Data source: WHO)


Of the recruited 600 participants, 60 are selected to play the computer game in one of the ten experimental situations. Throughout the duration of the game psychophysiological control variables are monitored, as well as individual performance within the game.

Experiment 1: In Computer Game 1, participants have to catch diamonds on a grid (approach motivation). At the same time, there is a possibility that a virtual robber might wake up and take away all diamonds that the participant has collected (avoidance motivation). In each game round, one of three robbers representing different probabilities of waking up is present but inactive in a corner of the grid. The behavioural response to different levels of threat is investigated by allowing the probability of an attack to vary across trials. In the beginning of each trial the predator resides inactive in a corner of the grid, while the participant can either start in the same corner (active start) or from a safe place” – a corner where the participant cannot be caught (passive start).

Experiment 2: Computer Game 2 is similar to Computer Game 1, but the grid is reduced to four squares. This forces participants to perform individual actions for collecting diamonds. Individual actions in this game relate to simple Go and No Go responses.

Experiment 3: Computer Game 1 with an additional aversive components (mild electrical stimulation/loud noises).

Experiment 4: Computer Game 2 with an additional aversive components (mild electrical stimulation/loud noises).

Experiment 5: Computer Game 1 with an additional possibility of catching the robber, to assess fight/flight tendencies.

Experiment 6: Computer Game 2 with an additional possibility of catching the robber, to assess fight/flight tendencies.

Experiment 7: Computer Game 1 with an additional possibility of sampling information

Criteria for participation in trial (Data source: BASEC)

• Gesunden Personen zwischen 18 und 40 Jahren
• Normale oder korrigierte Sehstärke
• Rechtshänder

Exclusion criteria (Data source: BASEC)

• Medikamenten- oder Drogeneinnahme in den 2 Wochen vor der Studie ausser Antibabypille und gelegentlicher Gebrauch von Schmerzmitteln (vom Aspirintyp, oder Paracetamol)
• klinisch relevante aktuelle Erkrankung
• Erkrankungen der Seele, des Nervensystems, des Immunsystems, und alle Arten andauernder entzündlicher Erkrankungen
• bekannte oder vermutete Abhängigkeit von Alkohol oder Drogen
• Unfähigkeit, die Studienanweisungen zu verstehen oder zu befolgen
• Teilnahme in einer Medikamentenstudie in den 30 Tagen vor bzw. während dieser Studie
• vorherige Teilnahme in dieser Studie
• Verwandtschaft oder Abhängigkeit von einem Mitglied des Studienteams

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
1. Informed Consent as documented by signature
2. Aged between 18 and 40 years
3. Normal vision

Exclusion criteria:
1. Reported use of any drugs in the 2 weeks prior to the study with the exception of contraceptive drugs and incidental use of NSARs or paracetamol
2. Reported clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
3. Reported history of psychiatric, neurological, dependence or systemic/rheumatic disease
4. Reported or suspected non-compliance, drug or alcohol abuse
5. Inability to follow the procedures of the study, e.g. due to language problems
6. Participation in a study with investigational drug within the 30 days preceding and during the present study
7. Previous enrolment into the current study
8. Members of the study team and their family members and dependants

Further information on the trial in WHO primary registry

http://isrctn.com/ISRCTN11198115

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN11198115
Further information on trial

Date trial registered

Oct 13, 2015

Incorporation of the first participant

Dec 1, 2015

Recruitment status

Ongoing

Academic title (Data source: WHO)

Psychological mechanisms of resolving approach-avoidance conflict - a behavioural study

Type of trial (Data source: WHO)

Observational

Design of the trial (Data source: WHO)

Observational cross sectional study (Other)

Phase (Data source: WHO)

Not Applicable

Primary end point (Data source: WHO)

Game performance is measured by the number of tokens collected during the 1-2 hour computer game.

Secundary end point (Data source: WHO)

The following outcomes are measured continuously while the participant is playing the video game:
1. Skin conductance responses is measured via two electrodes that are placed on the hand
2. Heart rate is measured via electrocardiogramm (ECG)
3. Respiration rate is measured via a distension-sensitive belt around the chest
4. Pupil size is measured with an eye-tracking device
5. Facial EMG is measured via two electrodes below the left eye

Contact information (Data source: WHO)

University of Zürich (Switzerland)

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Bach Dominik
+41443842457
dominik.bach@uzh.ch

Contact for scientific information (Data source: WHO)

Dominik
Bach
Psychiatric University Hospital (Psychiatrische Universitätsklinik) Lenggstrasse 31 Postfach 1931

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Further trial identification numbers

Secondary ID (Data source: WHO)

AAAB
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