Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention (IKSIT)

4. november 2015 opdateret af: University of Zurich

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
      • Zurich, Schweiz, 8032
        • University of Zurich

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cognitive behavioural Intervention
Adfærdsmæssigt: Cognitive Behavioural Training
Two day seminar
Eksperimentel: Integrative Kinesiology Intervention
Adfærdsmæssigt: Integrative Kinesiology Intervention
Two day seminar
Ingen indgriben: Waiting-List control group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under curve with respect to increase of salivary cortisol titer
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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

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
Perceived Stress
Tidsramme: 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
self efficacy expectancy
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Zurich

Efterforskere

  • Ledende efterforsker: Lars B. Sonderegger, University of Zurich
  • Studiestol: Reinhard Saller, Prof., University of Zurich
  • Studiestol: Ulrike Ehlert, Prof., University of Zurich

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2013

Primær færdiggørelse (Faktiske)

1. juli 2014

Studieafslutning (Faktiske)

1. september 2014

Datoer for studieregistrering

Først indsendt

4. april 2011

Først indsendt, der opfyldte QC-kriterier

6. april 2011

Først opslået (Skøn)

8. april 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IKSIT_2011

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cognitive Behavioural Training

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cyprus

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner