NCT02194478

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

July 16, 2014

Last Update Submit

August 31, 2016

Conditions

Stress

Keywords

StressMeditationMind body

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Salivary Cortisol Levels Change from baseline at week 8

    Baseline, Week 8

  • Lifestyle Profile change from baseline at week 8

    Baseline, Week 8

  • Work productivity and activity impairment change from baseline at week 8

    Baseline, Week 8

  • Promis-29 score change from baseline at week 8

    Baseline, Week 8

Study Arms (1)

8 Week Meditation

OTHER

Allina Health employees undergoing 8 week meditation intervention

Behavioral: Meditation

Interventions

MeditationBEHAVIORAL

30 minute, 8 week meditation

8 Week Meditation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged 18 to 65 years
  • Actively-working healthcare professional employed by Allina Health.

You may not qualify if:

  • Previous participation in an Allina Health stress reduction program
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allina Health

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jeffery Dusek, PhD

    Allina Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 18, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 1, 2016

Record last verified: 2016-08

Locations

US(1)