Comparative Intervention Study of Stress Reduction in Corporate Health Management

NCT ID: NCT02709551

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-07-31

Brief Summary

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Aim of the study is the evaluation of the effects (psychological and physiological) of an hrv-biofeedback training, a mindfulness training and a combination of both training methods for stress reduction.

Detailed Description

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Conditions

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Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRV-Bfb

HRV biofeedback, training about 30 minutes/day

Group Type EXPERIMENTAL

HRV_Bfb

Intervention Type BEHAVIORAL

MBI

Mindfulness based intervention, training about 30 minutes/day

Group Type EXPERIMENTAL

MBI

Intervention Type BEHAVIORAL

MBI_HRV-Bfb

Mindfulness based HRV biofeedback. Wait list control group for the interventions HRV-Bfb and MBI, after the main phase intervention with combined method.

Group Type OTHER

MBI_HRV_Bfb

Intervention Type BEHAVIORAL

Interventions

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HRV_Bfb

Intervention Type BEHAVIORAL

MBI

Intervention Type BEHAVIORAL

MBI_HRV_Bfb

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy adults
* Working in the business in which the study is conducted

Exclusion Criteria

* Cardiac disease
* Thyroid disease (intake of glucocorticoids)
* Actual psychological illness
* Intake of psychotropic drugs
* Intake of other medication changing HRV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität Tübingen

OTHER

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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STM_04

Identifier Type: -

Identifier Source: org_study_id

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