NCT02701361

Mobile Mindfulness to Improve Psychological Distress After Critical Illness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Many survivors of the intensive care unit (ICU) suffer from persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). In this study, the investigators will test the impact of mindfulness to address this distress.

Detailed description

A majority of the \>1 million people who require life support in an intensive care unit (ICU) now survive. As survival has improved however, growing numbers suffer not only from subsequent physical disability, but also persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). Few interventions address ICU survivors' psychological distress. Fewer still address the physical, geographical, and logistical barriers to receiving post-discharge support that medically ill populations encounter. Consequently, this population suffers with an unmet need of great public health importance. Mindfulness is an adaptable self-regulation practice that alleviates psychological distress symptoms using a variety of meditative techniques, typically taught face-to face over months. As an extension of standard mindfulness practices, the investigators developed a telephone-/web-delivered mobile mindfulness-based training (mMBT) system informed by ICU survivors' input that could address medically ill patients' delivery barriers. The investigators' recent pilot study demonstrated early support for mMBT's feasibility and acceptability, now with enhanced content and electronic patient-reported outcomes capability. The investigators' early work on mMBT, while promising, identified key knowledge gaps in population targeting, plausible ranges of psychological distress estimates relevant to study design, and assurance of acceptability that must be addressed before a definitive clinical trial is conducted. Therefore, the study team proposes a 2-year pilot study in which 90 ICU survivors are randomized to an education control, 'standard' telephone sessions of mMBT, or self-directed / app-based mMBT. A mixed methods approach will be used to determine treatment effect.

Conditions

• Psychological Distress
• Depression
• Anxiety
• Post-traumatic Stress Disorder
• Informal Caregivers
• Family Members

Interventions

Type	Name	Description
BEHAVIORAL	mobile mindfulness	Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.
BEHAVIORAL	standard mindfulness	Receives weekly calls from mindfulness expert for 4 weeks.
BEHAVIORAL	education	Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-05-01
• Completion: 2017-07-05
• First posted: 2016-03-08
• Last updated: 2018-02-07
• Results posted: 2018-01-10

Locations

2 sites across 1 country: United States