Clinical trial NCT01595555: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Individuals With Perceived Stress
Keywords: stress
relaxation
mindfulness
web-based
online
social media
discussion board
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2012-05-10
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effect of SFN on stress
timeFrame: End of intervention at week 8
measure: Effect of SFN on mindfulness
timeFrame: End of intervention at week 8
measure: Effect of SFN on self acceptance
timeFrame: End of intervention at week 8
measure: Effect of SFN on vitality
timeFrame: End of intervention at week 8
measure: Effect of SFN on spirituality
timeFrame: End of intervention at week 8
Secondary outcomes:
measure: SFN effect on physical and mental health
timeFrame: End of intervention at week 8
measure: Effect maintained at week 12 follow up
timeFrame: Week 12
measure: Assess whether adding Social Media to SFN improves engagement and outcome
timeFrame: Week 8 and 12
measure: Assess program engagement and adherence
timeFrame: Through the 8-week program
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Didier Allexandre, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Revati Wellness
name: Tom Morledge, M.D.
role: PRINCIPAL_INVESTIGATOR
References: