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OpenTrials
Completed

NCT Number: NCT01595555

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

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

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Key information

Conditions

Healthy Individuals With Perceived Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Free Now

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  1. SFN effect on physical and mental health

    Time frame: End of intervention at week 8

    Assess whether psycho-emotional improvement was accompanied with physical and mental health improvement as measured by SF36

  2. Effect maintained at week 12 follow up

    Time frame: Week 12

    To assess whether outcome improvements are maintained at week 12

  3. Assess whether adding Social Media to SFN improves engagement and outcome

    Time frame: Week 8 and 12

    To explore whether adding a message board component would enhance the effectiveness and experience of the program for participants

  4. Assess program engagement and adherence

    Time frame: Through the 8-week program

    Assess program engagement and adherence by collecting Stress Free Now and Social Media self report weekly practice data and Website usage

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • General Electric

Registry information

Official study title

Effectiveness of an Internet-based Mindfulness Program for Stress Management

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 10, 2012
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.