NCT01595555

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

May 8, 2012

Last Update Submit

May 6, 2022

Conditions

Keywords

stressrelaxationmindfulnessweb-basedonlinesocial mediadiscussion board

Outcome Measures

Primary Outcomes (5)

  • Effect of SFN on stress

    Assess whether SFN reduces stress as measured by the Perceived Stress Scale (PSS)

    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)

    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)

    End of intervention at week 8

  • Effect of SFN on vitality

    Assess whether SFN improves vitality as measured by the Subjective Vitality Scale (SVS)

    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)

    End of intervention at week 8

Secondary Outcomes (4)

  • SFN effect on physical and mental health

    End of intervention at week 8

  • Effect maintained at week 12 follow up

    Week 12

  • Assess whether adding Social Media to SFN improves engagement and outcome

    Week 8 and 12

  • Assess program engagement and adherence

    Through the 8-week program

Study Arms (3)

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

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

Behavioral: Stress Free Now

Interventions

Stress Free NowBEHAVIORAL

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.

Stress Free NowStress Free Now + Social Media

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, United States

Location

Related Links

Study Officials

  • Didier Allexandre, Ph.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
  • Tom Morledge, M.D.

    Revati Wellness

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 10, 2012

Study Start

September 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations