Study Summary
This trial will help optimize a mobile mindfulness intervention by comparing eight different iterations across various domains.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 12 Secondary · Reporting Duration: 3 months post-randomization
1 month post-randomization
Client Satisfaction Questionnaire (CSQ)
Systems Usability Scale (SUS)
3 months post-randomization
Intervention adherence
Month 3
Change in EuroQOL scale
Change in Mindful Attention Awareness Scale (MAAS)
Change in Patient Health Questionnaire 10-item scale (PHQ-10)
Change in Patient Health Questionnaire-9 Item scale (PHQ-9)
Distress associated with PTSD symptom frequency
Distress associated with anxiety symptom frequency
Mental Depression
Month 1
Change in Generalized Anxiety Disorder 7-item scale (GAD-7)
Change in Post-Traumatic Stress Symptom inventory (PTSS)
Trial Safety
Safety Progress
Trial Design
8 Treatment Groups
Standard dose / therapist attention / introductory call
1 of 8
High dose / therapist attention / no introductory call
1 of 8
High dose / app attention / introductory call
1 of 8
Standard dose / therapist attention / no introductory call
1 of 8
Standard dose / app attention / no introductory call
1 of 8
High dose / therapist attention / introductory call
1 of 8
High dose / app attention / no introductory call
1 of 8
Standard dose / app attention / introductory call
1 of 8
Experimental Treatment
240 Total Participants · 8 Treatment Groups
Primary Treatment: Mobile mindfulness-based training · No Placebo Group · N/A
Standard dose / therapist attention / introductory call
Behavioral
Experimental Group · 1 Intervention: Mobile mindfulness-based training · Intervention Types: BehavioralHigh dose / therapist attention / no introductory call
Behavioral
Experimental Group · 1 Intervention: Mobile mindfulness-based training · Intervention Types: BehavioralHigh dose / app attention / introductory call
Behavioral
Experimental Group · 1 Intervention: Mobile mindfulness-based training · Intervention Types: BehavioralStandard dose / therapist attention / no introductory call
Behavioral
Experimental Group · 1 Intervention: Mobile mindfulness-based training · Intervention Types: BehavioralStandard dose / app attention / no introductory call
Behavioral
Experimental Group · 1 Intervention: Mobile mindfulness-based training · Intervention Types: BehavioralHigh dose / therapist attention / introductory call
Behavioral
Experimental Group · 1 Intervention: Mobile mindfulness-based training · Intervention Types: BehavioralHigh dose / app attention / no introductory call
Behavioral
Experimental Group · 1 Intervention: Mobile mindfulness-based training · Intervention Types: BehavioralStandard dose / app attention / introductory call
Behavioral
Experimental Group · 1 Intervention: Mobile mindfulness-based training · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post-randomization
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,209 Previous Clinical Trials
3,220,806 Total Patients Enrolled
2 Trials studying Cardiorespiratory Failure
101 Patients Enrolled for Cardiorespiratory Failure
University of Colorado, DenverOTHER
1,608 Previous Clinical Trials
1,633,784 Total Patients Enrolled
University of WashingtonOTHER
1,612 Previous Clinical Trials
1,573,277 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
787 Previous Clinical Trials
657,219 Total Patients Enrolled
1 Trials studying Cardiorespiratory Failure
56 Patients Enrolled for Cardiorespiratory Failure
Christopher E Cox, MDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
191 Total Patients Enrolled
2 Trials studying Cardiorespiratory Failure
101 Patients Enrolled for Cardiorespiratory Failure
Eligibility Criteria
Age 18+ · All Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have normal cognitive function.
You are able to understand and make informed decisions about participating in the study.
You do not have a serious and ongoing mental illness.
References
- Cox, Christopher E., Maren K. Olsen, John A. Gallis, Laura S. Porter, Jeffrey M. Greeson, Tina Gremore, Allie Frear, et al.. 2020. “Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress (LIFT2): Design and Rationale of a Randomized Factorial Experimental Clinical Trial”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2020.106119.
- Cox, Christopher E, Catherine L Hough, Derek M Jones, Anna Ungar, Wen Reagan, Mary D Key, Tina Gremore, et al.. 2018. “Effects of Mindfulness Training Programmes Delivered by a Self-directed Mobile App and by Telephone Compared with an Education Programme for Survivors of Critical Illness: A Pilot Randomised Clinical Trial”. Thorax. BMJ. doi:10.1136/thoraxjnl-2017-211264.
- Cox, Christopher E., Laura S. Porter, Pamela J. Buck, Mary Hoffa, Derek Jones, Brenda Walton, Catherine L. Hough, and Jeffrey M. Greeson. 2014. “Development and Preliminary Evaluation of a Telephone-based Mindfulness Training Intervention for Survivors of Critical Illness”. Annals of the American Thoracic Society. American Thoracic Society. doi:10.1513/annalsats.201308-283oc.
- 2019. "Optimizing a Mobile Mindfulness Intervention for ICU Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038567.
Frequently Asked Questions
What is the scope of the research participants in this clinical investigation?
"This clinical trial requires a total of 240 individuals that match the criteria for participation. Patients from University of Washington in Seattle and University of Colorado - Denver in Aurora are eligible to join." - Anonymous Online Contributor
Unverified Answer
Is this research endeavor currently recruiting participants?
"The data hosted on clinicaltrials.gov confirms that this study is currently recruiting participants. The trial was unveiled on August 15th 2019 and the information has been kept up to date since February 8th 2022." - Anonymous Online Contributor
Unverified Answer