Comparison of the Efficacy of an Integrative-kinesiological to a Cognitive-behavioural Intervention (IKSIT)
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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. But it has not yet been thoroughly evaluated in a one to one setting which is more common in a counseling setting. 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 weekly training during 7 weeks for one hour 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Behavioral: Cognitive Behavioural Training Behavioral: Integrative Kinesiology Intervention |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Psychoneuroendocrinological Efficacy Study of an Integrative-kinesiological to a Cognitive-behavioural Intervention With Healthy Individuals |
- Area under curve with respect to increase of salivary cortisol titer [ Time Frame: 8x during TSST ] [ Designated as safety issue: No ]
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
- Salivary alpha amylase reactivity to the TSST [ Time Frame: 8x during TSST ] [ Designated as safety issue: No ]
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
- Sense of Coherence [ Time Frame: Baseline, post intervention and follow up ] [ Designated as safety issue: No ]
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)
- Perceived Stress [ Time Frame: Baseline, post intervention and follow up ] [ Designated as safety issue: No ]
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)
- self efficacy expectancy [ Time Frame: Baseline, post intervention and follow up ] [ Designated as safety issue: No ]
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)
| Estimated Enrollment: | 64 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cognitive behavioural Intervention |
Behavioral: Cognitive Behavioural Training
For 7 weeks, once per week for one hour
|
| Experimental: Integrative Kinesiology Intervention |
Behavioral: Integrative Kinesiology Intervention
For 7 weeks, once per week for one hour
|
| No Intervention: Waiting-List control group |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| Contact: Lars B. Sonderegger | +41796424515 | lars@access.uzh.ch |
| Switzerland | |
| University of Zurich | Not yet recruiting |
| Zurich, Switzerland, 8032 | |
| Contact: Dorentina Hoti +41444474515 info@ikamed.ch | |
| Contact: Lars Sonderegger +41796424515 lars.sonderegger@ikamed.ch | |
| Principal Investigator: Lars B. Sonderegger | |
| Principal Investigator: | Lars B. Sonderegger | University of Zurich |
| Study Chair: | Reinhard Saller, Prof. | University of Zurich |
| Study Chair: | Ulrike Ehlert, Prof. | University of Zurich |
More Information
No publications provided
| Responsible Party: | Lars Sonderegger, University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01331577 History of Changes |
| Other Study ID Numbers: | IKSIT_2011 |
| Study First Received: | April 4, 2011 |
| Last Updated: | April 6, 2011 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University of Zurich:
|
Healthy Primary Prevention Stress |
Kinesiology cognitive behavioural therapy Prevention |
ClinicalTrials.gov processed this record on May 22, 2013