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

Effectiveness of an Internet-based Mindfulness Program for Stress Management

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

Study Overview

• Status: Completed
• Conditions: Healthy Individuals With Perceived Stress
• Intervention / Treatment: Behavioral: Stress Free Now

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
• Enrollment (Actual): 684
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of SFN on stress	Assess whether SFN reduces stress as measured by the Perceived Stress Scale (PSS)	End of intervention at week 8
Effect of SFN on mindfulness	Assess whether SFN improves mindfulness as measured by the Mindfulness Attention Awareness Scale (MAAS)	End of intervention at week 8
Effect of SFN on self acceptance	Assess whether SFN improves self-acceptance as measured by the Psychological Well-being - Self-Acceptance Subscale (PWb-SA)	End of intervention at week 8
Effect of SFN on vitality	Assess whether SFN improves vitality as measured by the Subjective Vitality Scale (SVS)	End of intervention at week 8
Effect of SFN on spirituality	Assess whether SFN improves transcendence as measured by the Adult Self-Transcendence Inventory (ASTI)	End of intervention at week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SFN effect on physical and mental health	Assess whether psycho-emotional improvement was accompanied with physical and mental health improvement as measured by SF36	End of intervention at week 8
Effect maintained at week 12 follow up	To assess whether outcome improvements are maintained at week 12	Week 12
Assess whether adding Social Media to SFN improves engagement and outcome	To explore whether adding a message board component would enhance the effectiveness and experience of the program for participants	Week 8 and 12
Assess program engagement and adherence	Assess program engagement and adherence by collecting Stress Free Now and Social Media self report weekly practice data and Website usage	Through the 8-week program

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: mindfulness; stress; relaxation; social media; online; web-based; discussion board
• Other Study ID Numbers: 10-278