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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Zurich, Sveits, 8032
- University of Zurich
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Cognitive behavioural Intervention
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Two day seminar
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Eksperimentell: Integrative Kinesiology Intervention
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Two day seminar
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Ingen inngripen: Waiting-List control group
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Area under curve with respect to increase of salivary cortisol titer
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Salivary alpha amylase reactivity to the TSST
Tidsramme: 8x during TSST
|
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
Tidsramme: Baseline, post intervention and follow up
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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
Tidsramme: Baseline, post intervention and follow up
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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
Tidsramme: Baseline, post intervention and follow up
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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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Lars B. Sonderegger, University of Zurich
- Studiestol: Reinhard Saller, Prof., University of Zurich
- Studiestol: Ulrike Ehlert, Prof., University of Zurich
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IKSIT_2011
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