Stress Reduction for Busy Professionals

Stress Clinical Trial

Official title:

Pilot Study of a Brief Mind/Body Meditation Intervention for Allina Health Employees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194478
• Other study ID #: S091301
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: August 31, 2016
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week mind-body/meditation intervention on self-reported quality of life in individuals employed by Allina Health. Outcomes will include validated questionnaires for depressive symptomology, perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes of salivary cortisol for a sub-sample of employees.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men and women aged 18 to 65 years

• Actively-working healthcare professional employed by Allina Health.

Exclusion Criteria:

• Previous participation in an Allina Health stress reduction program

• Non-English speaking

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Meditation
30 minute, 8 week meditation

Locations

Country	Name	City	State
United States	Allina Health	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived stress change from baseline at week 8	Perceived stress will be measured through the Perceived Stress Scale at baseline and week 8.	Baseline, Week 8	No
Secondary	Salivary Cortisol Levels Change from baseline at week 8	Salivary samples will be obtained at baseline and week 8.	Baseline, Week 8	No
Secondary	Lifestyle Profile change from baseline at week 8	The Lifestyle Profile questionnaire measures self actualization, health responsibility, exercise, nutrition, interpersonal support, and stress management. It will be administered at baseline and week 8.	Baseline, Week 8	No
Secondary	Work productivity and activity impairment change from baseline at week 8	Work productivity and activity impairment will be measured through the WPAI:GH and will be administered at baseline and week 8.	Baseline, Week 8	No
Secondary	Promis-29 score change from baseline at week 8	The Promis-29 is a 29 item questionnaire measuring physical function, fatigue, pain, depression, anxiety, and social role participation. The questionnaire will be administered at baseline and week 8.	Baseline, Week 8	No