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

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

Detailed Description
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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.

Official Title
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Effectiveness of an Internet-based Mindfulness Program for Stress Management

Conditions
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Healthy Individuals With Perceived Stress

Intervention / Treatment
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* Behavioral: Stress Free Now


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait-list control<br>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<br>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<br>* 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.<br>|
| Experimental: Stress Free Now + Social Media<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relaxation, mindfulness, web-based, online, social media, discussion board, stress