Healthy Individuals With Perceived StressNCT01595555
Effectiveness of Stress Free Now: an Internet-based Mindfulness Program for Stress Management
A study testing Stress Free Now in people with Healthy Individuals With Perceived Stress, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This research will examine whether an Internet-based mindfulness program for stress management produced positive outcomes for participants and is technologically feasible Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals With Perceived Stress
- What is being tested?
- Stress Free Now
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of 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
Read the 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.
- Being tested
- Stress Free Now
- Keywords
- stress, relaxation, mindfulness, web-based, online, social media, discussion board
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Free NowBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Wait-list control | No intervention | 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 | 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 Receives: Behavioral: Stress Free Now |
| Stress Free Now + Social Media | Experimental | 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 Receives: Behavioral: Stress Free Now |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of SFN on stress
Assess whether SFN reduces stress as measured by the Perceived Stress Scale (PSS)
Measured: End of intervention at week 8
Effect of SFN on mindfulness
Assess whether SFN improves mindfulness as measured by the Mindfulness Attention Awareness Scale (MAAS)
Measured: End of intervention at week 8
Effect of SFN on self acceptance
Assess whether SFN improves self-acceptance as measured by the Psychological Well-being - Self-Acceptance Subscale (PWb-SA)
Measured: End of intervention at week 8
Effect of SFN on vitality
Assess whether SFN improves vitality as measured by the Subjective Vitality Scale (SVS)
Measured: End of intervention at week 8
Effect of SFN on spirituality
Assess whether SFN improves transcendence as measured by the Adult Self-Transcendence Inventory (ASTI)
Measured: End of intervention at week 8
Secondary outcomes (4)
SFN effect on physical and mental health
Assess whether psycho-emotional improvement was accompanied with physical and mental health improvement as measured by SF36
Measured: End of intervention at week 8
Effect maintained at week 12 follow up
To assess whether outcome improvements are maintained at week 12
Measured: Week 12
Assess whether adding Social Media to SFN improves engagement and outcome
To explore whether adding a message board component would enhance the effectiveness and experience of the program for participants
Measured: Week 8 and 12
Assess program engagement and adherence
Assess program engagement and adherence by collecting Stress Free Now and Social Media self report weekly practice data and Website usage
Measured: Through the 8-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Individuals With Perceived StressStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Principal investigator, Linda Libertini, The Cleveland Clinic
- Investigators
- Didier Allexandre, Ph.D., Principal investigator, The Cleveland ClinicTom Morledge, M.D., Principal investigator, Revati Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595555
- Sponsor's protocol ID
- 10-278
- Status last verified
- May 2022
- First submitted
- 8 May 2012
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Internet-based Mindfulness Program for Stress Management
- ClinicalTrials.gov ID
- NCT01595555
- Acronym / sponsor ID
- 10-278
- Keywords
- stress, relaxation, mindfulness, web-based, online, social media, discussion board
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wait-list control | No intervention | –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 | Behavioral: Stress Free NowParticipate 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 |
| Stress Free Now + Social Media | Experimental | Behavioral: Stress Free NowParticipate 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Free Now8 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. | Behavioural | Stress Free Now, Stress Free Now + Social Media |
Primary outcome
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 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 spirituality
Time frame: End of intervention at week 8
Assess whether SFN improves transcendence as measured by the Adult Self-Transcendence Inventory (ASTI)
4 secondary outcomes
SFN effect on physical and mental health
Time frame: End of intervention at week 8
Effect maintained at week 12 follow up
Time frame: Week 12
Assess whether adding Social Media to SFN improves engagement and outcome
Time frame: Week 8 and 12
Assess program engagement and adherence
Time frame: Through the 8-week program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Link to the Stress Free Now online programLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Allexandre, Ph.D. principal investigator
The Cleveland Clinic
Tom Morledge, M.D. principal investigator
Revati Wellness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Free Now in people with Healthy Individuals With Perceived Stress, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of SFN on stress (time frame: End of intervention at week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.