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

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

Tracking Information

• First Submitted Date: May 8, 2012
• First Posted Date: May 10, 2012
• Last Update Posted Date: August 8, 2012
• Study Start Date: September 2010
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Stress Free Now: an Internet-based Mindfulness Program for Stress Management
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy Individuals With Perceived Stress

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 9, 2012): 684
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01595555
• Other Study ID Numbers: 10-278
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: The Cleveland Clinic
• Study Sponsor: The Cleveland Clinic
• Collaborators: General Electric

Investigators

• 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