Online Mindfulness Program for Stress Management

NCT03753360 | Completed

• 1 other identifier: 18-681
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective parallel non-blinded randomized study with two arms, an intervention group and an active control group. Sixty healthy, but stressed nurses will be randomly assigned to either participate in a 6-week internet-based mindfulness meditation program produced by the Cleveland Clinic called Stress Free Now for Healers or to listen to relaxing music for at least 5 minutes a day for 6 weeks, and pre-post comparisons will be made for RNA expression profiles, plasma cytokine concentrations, telomerase activity, 6-point salivary cortisol and several self-reported assessments of physical and mental health.

Conditions

Stress, Psychological; Burnout, Professional

Keywords

Stress; Mindfulness; Meditation; Gene expression; Immune; Online; Healthcare workers; Burnout; Cytokines; Cortisol

Outcome Measures

Primary Outcomes (7)

• Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group.

  Next Generation Sequencing (NGS) will be used to measure whole transcriptome RNA expression in peripheral blood mononuclear cells (PBMCs) of subjects before and after participation in Stress Free Now or the control intervention. This data will then be used to create a pre-post differential expression signature to identify genes that were significantly up- or downregulated across the entire group. The within group changes will then be compared between the intervention and the control group and analyzed for significant differences.

  6 weeks

• Pre-/post-intervention changes in IL-6

  Measure plasma concentrations of IL-6 before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  6 weeks

• Pre-/post-intervention changes in IL-8

  Measure plasma concentrations of IL-8 before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  6 weeks

• Pre-/post-intervention changes in IL-10

  Measure plasma concentrations of IL-10 before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  6 weeks

• Pre-/post-intervention changes in TNF-α

  Measure plasma concentrations of TNF-α before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  6 weeks

• Pre-/post-intervention changes in IFN-γ

  Measure plasma concentrations of IFN-γ before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  6 weeks

• Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity

  Measure telomerase activity in PBMCs before and after participation in Stress Free Now for Healers or the control intervention and compare the change over time between groups.

  6 weeks

Secondary Outcomes (12)

• Pre-/post-intervention changes in salivary cortisol awakening response

  6 weeks

• Pre-/post-intervention changes in evening salivary cortisol

  6 weeks

• Pre-/post-intervention changes in diurnal cortisol slope

  6 weeks

• Pre-/post-intervention changes in perceived stress

  6 and 12 weeks

• Pre-/post-intervention changes in resilience

  6 and 12 weeks

Study Arms (2)

Intervention Group

OTHER

internet-based mindfulness meditation program

Behavioral: Internet-Based Mindfulness Program - Stress Free Now for Healers

Active Control Group

OTHER

relaxing music

Behavioral: Active Control Group - Relaxing Music

Interventions

Internet-Based Mindfulness Program - Stress Free Now for Healers BEHAVIORAL

Stress Free Now for Healers is an online stress management program developed at Cleveland. It's delivered in 4 components:1Weekly introductions to the concepts and meditation theme are delivered via Web page views or a 5to10-min audio clip2Weekly guided meditations 5-20 min ea.available as embedded/downloadable mp3 on the website or via the Stress Free Now for Healers phone app,which participants are invited to practice at least 4 times each week and to record those practices3Daily articles provide the scientific underpinnings and merits of each week's theme or discuss various cognitive and behavioral strategies,activities,and concepts supporting or related to mindfulness4Daily tips suggesting how to manage stress or incorporate mindfulness in daily activities,including motivational quotes.Participants will have access to a smartphone app with recordings of the 11 guided meditations.Ea. participant will be assigned an e-coach that will communicate with the participant at least weekly.

Intervention Group

Active Control Group - Relaxing Music BEHAVIORAL

The control group will be given a flash drive and a link to a website where they can download several digital recordings of relaxing music and will be instructed to quietly listen to one or more of the recordings for at least 5 minutes every day for 6 weeks.

Active Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female CCF nurses
• Abbreviated perceived stress scale (PSS-4) ≥ 7
• English speaking
• No history of major chronic medical conditions and/or diseases
• Able to provide informed consent and comply with study protocol

You may not qualify if:

• Significant chronic medical condition and/or disease
• Smoking
• Pregnancy
• Current use of antidepressants or any other psychiatric medication
• Current diagnosis of anxiety and/or depression
• History of any psychiatric diagnosis other than anxiety or depression
• Estrogen or hormone replacement therapy use
• Diagnosis of post-traumatic stress disorder
• Current use of any immunosuppressive medication
• No current or past meditation practice

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.

  PMID: 32627860 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Burnout, Professional; Burnout, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Occupational Stress; Occupational Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the RJ Fasenmyer Center for Clinical Immunology

Model Details: Prospective Parallel non-blinded randomized two arms, intervention group and active control group

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 27, 2018
• Study Start: November 27, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)