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

NeuroTherapia, Inc.

Status: Completed

Conditions: Healthy Individuals With Perceived Stress

Treatments: Behavioral: Stress Free Now

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01595555

10-278

Details and patient eligibility

About

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

Full 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.

Enrollment: 684 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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684 participants in 3 patient groups

Wait-list control

No Intervention group

Description:

Group with no intervention. Only complete questionnaires at baseline, week 8 and 12 and activity logs through the first 8 weeks

Stress Free Now

Experimental group

Description:

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

Treatment:

Behavioral: Stress Free Now

Stress Free Now + Social Media

Experimental group

Description:

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

Treatment:

Behavioral: Stress Free Now