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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

Study Description
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Brief Summary:
This research will examine whether an Internet-based mindfulness program for stress management produced positive outcomes for participants and is technologically feasible

Condition or disease Intervention/treatment Phase
Healthy Individuals With Perceived Stress Behavioral: Stress Free Now Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of an Internet-based Mindfulness Program for Stress Management
Study Start Date : September 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011
Arms and Interventions
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Arm Intervention/treatment
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
 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.
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)


Secondary Outcome Measures :
  1. 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

  2. Effect maintained at week 12 follow up [ Time Frame: Week 12 ]
    To assess whether outcome improvements are maintained at week 12

  3. 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

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595555


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States
Sponsors and Collaborators
The Cleveland Clinic
General Electric
Investigators
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Principal Investigator: Didier Allexandre, Ph.D. The Cleveland Clinic
Principal Investigator: Tom Morledge, M.D. Revati Wellness
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01595555    
Other Study ID Numbers: 10-278
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012
Keywords provided by The Cleveland Clinic:
stress
relaxation
mindfulness
web-based
 online
social media
discussion board