Effectiveness of an Internet-based Mindfulness Program for Stress Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Individuals With Perceived Stress
- Sponsor
- The Cleveland Clinic
- Enrollment
- 684
- Locations
- 1
- Primary Endpoint
- Effect of SFN on vitality
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Linda Libertini
Research Coordinator
The Cleveland Clinic
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 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 spirituality
Time Frame: End of intervention at week 8
Assess whether SFN improves transcendence as measured by the Adult Self-Transcendence Inventory (ASTI)
Secondary Outcomes
- SFN effect on physical and mental health(End of intervention at week 8)
- Assess program engagement and adherence(Through the 8-week program)
- Assess whether adding Social Media to SFN improves engagement and outcome(Week 8 and 12)
- Effect maintained at week 12 follow up(Week 12)