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Effectiveness of Stress Free Now: an Internet-based Mindfulness Program for Stress Management

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ClinicalTrials.gov Identifier: NCT01595555
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : August 8, 2012
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 10, 2012
Last Update Posted Date August 8, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
  • Effect of SFN on stress [ Time Frame: End of intervention at week 8 ]
    Assess whether SFN reduces stress as measured by the Perceived Stress Scale (PSS)
  • Effect of SFN on mindfulness [ Time Frame: End of intervention at week 8 ]
    Assess whether SFN improves mindfulness as measured by the Mindfulness Attention Awareness Scale (MAAS)
  • Effect of SFN on self acceptance [ Time Frame: End of intervention at week 8 ]
    Assess whether SFN improves self-acceptance as measured by the Psychological Well-being - Self-Acceptance Subscale (PWb-SA)
  • Effect of SFN on vitality [ Time Frame: End of intervention at week 8 ]
    Assess whether SFN improves vitality as measured by the Subjective Vitality Scale (SVS)
  • Effect of SFN on spirituality [ Time Frame: End of intervention at week 8 ]
    Assess whether SFN improves transcendence as measured by the Adult Self-Transcendence Inventory (ASTI)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
  • SFN effect on physical and mental health [ Time Frame: End of intervention at week 8 ]
    Assess whether psycho-emotional improvement was accompanied with physical and mental health improvement as measured by SF36
  • Effect maintained at week 12 follow up [ Time Frame: Week 12 ]
    To assess whether outcome improvements are maintained at week 12
  • Assess whether adding Social Media to SFN improves engagement and outcome [ Time Frame: Week 8 and 12 ]
    To explore whether adding a message board component would enhance the effectiveness and experience of the program for participants
  • Assess program engagement and adherence [ Time Frame: Through the 8-week program ]
    Assess program engagement and adherence by collecting Stress Free Now and Social Media self report weekly practice data and Website usage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Stress Free Now: an Internet-based Mindfulness Program for Stress Management
Official Title  ICMJE Effectiveness of an Internet-based Mindfulness Program for Stress Management
Brief Summary This research will examine whether an Internet-based mindfulness program for stress management produced positive outcomes for participants and is technologically feasible
Detailed Description

Chronic, severe stress, a risk factor for premature aging and myocardial infarction, affects 35% of North Americans. Stress management programs, while effective, may be prohibitively resource intensive or difficult to access by broad populations.

This research is examining whether an online stress management program - Stress Free Now© (SFN) - can achieve meaningful improvements in measures of stress and wellbeing. We are also examining whether improvements in wellbeing and stress can be enhanced through an online, internet based support group which share experiences as they go through the Stress Free Now program. This program is modeled after an intensive group program, called Mindfulness Based Stress Reduction (MBSR), which has shown benefits across a broad array of medical issues in addition to more specific stress related problems.

This is a three arm randomized controlled trial which will last for 12 weeks. Participants will be randomized into one of the study arms: Non intervention Control, Stress Free Now and Stress Free Now + Message Board. We aim at enrolling 600 participants, with the expectation that 50% will complete the study (100 per group).

A series of questionnaires will be collected at baseline, at the end of the 8-week program and at follow up at week 12. Outcome measured are stress, mindfulness, vitality, physical, social and emotional health, transcendence and self-acceptance. We will also ask participants to complete a weekly log to measure program adherence and usage.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Individuals With Perceived Stress
Intervention  ICMJE Behavioral: Stress Free Now
8 week mindfulness online program with the following content: 8 Weekly lesson of the week (audio), 8 Weekly mindfulness practice (audio), Daily articles on concepts and information about stress, relaxation and mindfulness, Daily motivational quotes and tips, Biweekly email reminder to participate in the program.
Study Arms  ICMJE
  • No Intervention: Wait-list control
    Group with no intervention. Only complete questionnaires at baseline, week 8 and 12 and activity logs through the first 8 weeks
  • Experimental: Stress Free Now
    Participate in the 8 week online stress management program Stress Free Now. Complete questionnaires at baseline, week 8 and 12 and activity logs through the first 8 weeks
    Intervention: Behavioral: Stress Free Now
  • Experimental: Stress Free Now + Social Media
    Participate in the 8-week Stress Free Now program and a discussion board that provides peer and moderator support. Complete questionnaires at baseline, week 8 and 12 and activity logs through the first 8 weeks
    Intervention: Behavioral: Stress Free Now
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2012)
684
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • Sign-up for SFN (if in one of the intervention groups)
  • Agree to participate in the research
  • Have regular access to the internet
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595555
Other Study ID Numbers  ICMJE 10-278
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE General Electric
Investigators  ICMJE
Principal Investigator: Didier Allexandre, Ph.D. The Cleveland Clinic
Principal Investigator: Tom Morledge, M.D. Revati Wellness
PRS Account The Cleveland Clinic
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP