- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01331577
Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention (IKSIT)
Psychoneuroendocrinological Efficacy Study of an Integrative-kinesiological to a Cognitive-behavioural Intervention With Healthy Individuals
Stress is a common problem with significant consequences for health. It can be a trigger for somatic diseases as well as psychological disorders and leads through missed working days and healthcare cost to a high economic loss. It is for health and economic reasons essential to develop and evaluate effective interventions that can inoculate against stress and build inner strength.
A cognitive-behavioural training for groups that is well evaluated and has shown to be effective is the Stress-Inoculation-Training by Meichenbaum. As the public utilization of methods of the complementary and alternative medicine is increasing a rigorous evaluation is needed. Integrative Kinesiology is a popular method that has been said to be effective against stress and its symptoms.
The investigators propose a randomized controlled evaluation and comparison of the interventions to each other and to a waiting-list control group. Hypothesis: Healthy volunteers attending a two dayseminar will show significantly reduced psychobiological reactivity, decreased stress perception and less anxiety to a standardized psychosocial stress test compared to the waiting list group. A total of 64 healthy volunteers will be randomly assigned to one of the three groups. The efficacy of the interventions will be measured through the Trier Social Stress Test (TSST) to measure the psychobiological stress reactivity.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Zurich, Schweiz, 8032
- University of Zurich
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Ready to participate in randomly one of the three groups
- mentally and physically healthy
- Sufficient German-speaking abilities to participate in the training
Exclusion Criteria:
- previous experience with Integrative Kinesiology or cognitive-behavioural therapy
- previous experience with the Trier Social Stress Test
- daily alcohol consumption: > two alcoholic drinks
- daily tobacco consumption: > 5 cigarettes per day
- any kind of drug abuse
- pregnancy, after the second trimenon
- intake ofe hormonal compounds (birth control pill and hormon replacement therapy)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Cognitive behavioural Intervention
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Two day seminar
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Experimental: Integrative Kinesiology Intervention
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Two day seminar
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Kein Eingriff: Waiting-List control group
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Area under curve with respect to increase of salivary cortisol titer
Zeitfenster: 8x during TSST
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TSST evaluation day will take place between 2 weeks and one month on average after the treatments are finished. Trier Social Stress Tests procedure will last close to two hours. Samples are collected at: T + 02; +25; +38; +48; +58; + 1:08; +1:23; + 1.38 |
8x during TSST
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Salivary alpha amylase reactivity to the TSST
Zeitfenster: 8x during TSST
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TSST evaluation day will take place between 2 weeks and one month on average after the treatments are finished. Trier Social Stress Tests procedure will last close to two hours. Samples are collected at: T + 02; +25; +38; +48; +58; + 1:08; +1:23; + 1.38 |
8x during TSST
|
Sense of Coherence
Zeitfenster: Baseline, post intervention and follow up
|
Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Sense of Coherence questionnaire (SOC-L9) |
Baseline, post intervention and follow up
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Perceived Stress
Zeitfenster: Baseline, post intervention and follow up
|
Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Perceived Stress Scale (PSS) |
Baseline, post intervention and follow up
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self efficacy expectancy
Zeitfenster: Baseline, post intervention and follow up
|
Baseline: After recruitment and acceptance to the study Post: One week after the training is fulfilled Follow-up: One week after the TSST Measured by: Self-efficacy-expectancy questionnaire (SWE) |
Baseline, post intervention and follow up
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Lars B. Sonderegger, University of Zurich
- Studienstuhl: Reinhard Saller, Prof., University of Zurich
- Studienstuhl: Ulrike Ehlert, Prof., University of Zurich
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- IKSIT_2011
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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