Comparative Intervention Study of Stress Reduction in Corporate Health Management
NCT02709551, Not applicable, Completed, ARCIM Institute Academic Research in Complementary and Integrative Medicine
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Comparative Intervention Study of Stress Reduction in Corporate Health Management | ClinicalTrials.gov |
| NCT number | NCT02709551 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | ARCIM Institute Academic Research in Complementary and Integrative Medicine | ClinicalTrials.gov |
| Conditions | Stress, Psychological | ClinicalTrials.gov |
| Interventions | HRV_Bfb, MBI, MBI_HRV_Bfb | ClinicalTrials.gov |
| First posted | 2016-03-16 | ClinicalTrials.gov |
| Last updated | 2016-03-16 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Alteration in psychological parameters of stress perception after training | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | We assessed psychological parameters of stress perception with the following questionnaire: TICS ("Trierer Inventar zum chronischen Stress"; Schulz, Schlotz \& Becker, 2004). Alteration in data will be statistically compared. | ClinicalTrials.gov |
| Primary | Alteration in psychological parameters of stress coping (behavioral skills) after training | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | We assessed psychological parameters of stress coping with the following questionnaire: SVF 120 ("Stressverarbeitungsfragebogen; Janke \& Erdmann, 1997). Alteration in data will be statistically compared. | ClinicalTrials.gov |
| Primary | Alteration in psychological parameters of stress coping (behavior pattern) after training | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | We assessed psychological parameters of stress coping with the following questionnaire: AVEM ("Arbeitsbezogene Verhaltens- und Erlebensmuster"; Schaarschmidt \& Fischer, 2008). Alteration in data will be statistically compared. | ClinicalTrials.gov |
| Primary | Alteration in physiological parameters of stress: HRV parameters | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | For the physiological assessment of HRV we used the HRV-Scanner from BioSign GmbH which gathers different HRV parameters like RMSSD and pNN50. HRV was assessed before and after a stressor (Stroop Color-Word Task (based on findings by Stroop, 1935) and D2-R Concentration and Endurance test (Brickenkamp et al., 2010). Alteration in data will be statistically compared. | ClinicalTrials.gov |
| Primary | Alteration in physiological parameters of stress: Salivary cortisol | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | Cortisol was assessed as salivary cortisol (one sample per subject per assessment point). Alteration in data will be statistically compared. | ClinicalTrials.gov |
| Secondary | Alteration in psychological parameters of psychological wellbeing after training | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | We assessed psychological wellbeing with the following questionnaire: HEALTH-49 ("Kurzversion der Hamburger Module zur Erfassung allgemeiner Aspekte psychosozialer Gesundheit für die therapeutische Praxis"; Rabung, Harfst, Koch \& Schulz, 2007). Alteration in data will be statistically compared. | ClinicalTrials.gov |
| Secondary | Alteration in psychological parameters of depression after training | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | We assessed depressive symptoms with the following questionnaire: Beck Depressions-Inventar (BDI-II; Hautzinger, Keller \& Kühner; 2006). Alteration in data will be statistically compared. | ClinicalTrials.gov |
| Secondary | Alteration in psychological parameters of mindfulness after training | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | We assessed mindfulness with the following questionnaire: FFA 14 ("Kurzversion des Freiburger Fragebogens zur Achtsamkeit"; Walach et al., 2006). Alteration in data will be statistically compared. | ClinicalTrials.gov |
| Secondary | Alteration in psychological parameters of self-compassion after training | H0: Baseline time point of assessment prior to training H1: Post training time point of assessment (6 weeks after H0) H2: Follow-up (12 weeks after H0) H3: Post training time point of assessment for former wait-list control group (18 weeks after H0) | We assessed self-compassion with the following questionnaire: SCS-D-Kurzform ("Self-Compassion Scale"; Hupfeld \& Ruffieux, 2011). Alteration in data will be statistically compared. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)