Mobile Mindfulness to Improve Psychological Distress After Critical Illness

Duke University

Status: Completed

Conditions: Family Members; Post-traumatic Stress Disorder; Depression; Anxiety; Informal Caregivers; Psychological Distress

Treatments: Behavioral: standard mindfulness; Behavioral: education; Behavioral: mobile mindfulness

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02701361

R34AT008819 (U.S. NIH Grant/Contract)

Pro00064250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (the investigators will target patients at high risk for psychological distress):

• age ≥18 years

• acute cardiorespiratory failure managed in an intensive care unit

• reside at home before hospital admission (i.e., not in a facility)

  • Respiratory failure, ≥1 of these:

• mechanical ventilation via endotracheal tube for ≥ 12 hours

• non-invasive ventilation (CPAP, BiPAP) for > 4 hours in a 24 hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)

• high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours

  • Cardiac / circulatory failure, ≥1 of these:

• use of vasopressors for shock of any etiology for > 1 hour

• use of inotropes for shock of any etiology for > 1 hour

• use of aortic balloon pump for cardiogenic shock

Exclusion Criteria (present before consent): Patients will be excluded if they have characteristics that would prohibit adequate participation including:

• pre-existing significant cognitive impairment (e.g., dementia)
• treated for severe or unstable mental illness within 6 months preceding current admission (e.g., depression with psychosis, suicidality, schizophrenia as per medical record)
• hospital inpatient within 3 months before current admission
• active substance abuse at the time of admission
• lack of decisional capacity [*'Decisional capacity' is defined as the ability to participate in effective decision making and provide informed consent. That is, in the judgment of the examiner, the patient, after reading the IRB approved patient consent document (or having it read to them) can (a) generally understand the terms of participation in the study: the purpose of the study, what will be required of study participants; the potential risks, benefits and alternatives of study participation; pros & cons of study involvement and (b) can communicate a choice in his/her own words (or write on a communication board)]
• current significant cognitive impairment (≥3 errors on the Callahan cognitive status screen; see below)
• need for a translator because of poor English fluency [many study instruments are not validated in other languages]
• expected survival <6 months per attending physician
• ICU length of stay >30 days
• lack of either:
• reliable or sufficient smartphone with cellular data plan or
• reliable computer online access plus telephone access
• unable to complete study procedures as determined by study staff
• discharge to a location other than a home setting
• complex medical care expected soon after discharge (e.g., multiple planned surgeries, transplantation evaluation (including outpatient daily cardiopulmonary rehabilitation), extensive travel needs for hemodialysis, disruptive chemotherapy or XRT regimen, etc)

Other issues relevant to the consent process:

• unable to approach patient for logistical reasons (e.g., off ward in test at time of approach, etc)
• patient discharged before consent could be obtained
• patient dies before consent obtained

Patient exclusion criteria present after consent but before randomization:

After providing informed consent, patients will become ineligible if any of the following are present:

• they become too ill to participate (or die)
• they exhibit significant cognitive disability
• they exhibit suicidality
• patient was unexpectedly discharged to location other than a home setting and then did not arrive home within 1 month from hospital discharge

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Education group

Active Comparator group

Description:

A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.

Treatment:

Behavioral: education

Standard mindfulness

Experimental group

Description:

Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.

Treatment:

Behavioral: standard mindfulness

Mobile mindfulness

Experimental group

Description:

Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.

Treatment:

Behavioral: mobile mindfulness