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

Effectiveness of an Internet-based Mindfulness Program for Stress Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01595555
Enrollment
684
Registered
2012-05-10
Start date
2010-09-30
Completion date
2011-11-30
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Individuals With Perceived Stress

Keywords

stress, relaxation, mindfulness, web-based, online, social media, discussion board

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.

Interventions

BEHAVIORALStress 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.

Sponsors

General Electric
CollaboratorINDUSTRY
The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of SFN on spiritualityEnd of intervention at week 8Assess whether SFN improves transcendence as measured by the Adult Self-Transcendence Inventory (ASTI)
Effect of SFN on stressEnd of intervention at week 8Assess whether SFN reduces stress as measured by the Perceived Stress Scale (PSS)
Effect of SFN on mindfulnessEnd of intervention at week 8Assess whether SFN improves mindfulness as measured by the Mindfulness Attention Awareness Scale (MAAS)
Effect of SFN on self acceptanceEnd of intervention at week 8Assess whether SFN improves self-acceptance as measured by the Psychological Well-being - Self-Acceptance Subscale (PWb-SA)
Effect of SFN on vitalityEnd of intervention at week 8Assess whether SFN improves vitality as measured by the Subjective Vitality Scale (SVS)

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026