Mobile Mindfulness to Improve Psychological Distress After Critical Illness

Depression Clinical Trial

Official title:

Mobile Mindfulness to Improve Psychological Distress After Critical Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701361
• Other study ID #: Pro00064250
• Secondary ID: R34AT008819
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: January 11, 2018
• Start date: March 2016
• Est. completion date: July 5, 2017

Study information

• Verified date: January 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 5, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Critical Illness
• Depression
• Family Members
• Informal Caregivers
• Post-traumatic Stress Disorder
• Psychological Distress
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	National Center for Complementary and Integrative Health (NCCIH), University of Pennsylvania, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cox CE, Porter LS, Buck PJ, Hoffa M, Jones D, Walton B, Hough CL, Greeson JM. Development and preliminary evaluation of a telephone-based mindfulness training intervention for survivors of critical illness. Ann Am Thorac Soc. 2014 Feb;11(2):173-81. doi: 10.1513/AnnalsATS.201308-283OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability Themes Developed From Semi-structured Participant Interviews	A usability measure. Open-ended feedback questions will be arranged in themes.	end of study
Primary	Percent of Eligible Participants Who Provided Consent	Percent of eligible participants who provided consent. Because this includes eligible yet not-as-yet randomized participants, there are no study arm differences analyzed. This is a feasibility measure. Target is 70%.	pre-randomization
Primary	Percent of Eligible Participants Who Provide Informed Consent and Were Randomized	Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.	randomization
Primary	Client Satisfaction Questionnaire (CSQ) Score	Acceptability was measured with the adapted Client Satisfaction Questionnaire (CSQ), which assesses credibility and satisfaction (range 9 [low, a worse outcome] to 36 [highest, a better outcome]). Target is mean score >10.	1 month post-randomization
Primary	System Usability Scale (SUS)	Usability of the mobile app was assessed with open-ended participant feedback and with the 10-item System Usability Scale (SUS; 0 [lowest] to 100 [highest]). A SUS score above a 68 would be considered above average and anything below 68 is below average.	1 month post-randomization
Primary	Percent of Randomized Participants Who Drop Out of Study	A feasibility measure. Target is 20% or less.	baseline, end of study (approx. 4 months)
Primary	Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews	Percent of participants who have neither dropped out nor died who complete telephone interviews. A feasibility measure. Target is 75%.	baseline, end of study (approx. 4 months)
Primary	Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys	A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.	baseline, end of study (approx. 4 months)
Primary	Percentage of Self-directed MBT Sessions Attended by Eligible Participants	A feasibility measure. Target is 50% among those who neither dropped out nor died.	baseline, end of study (approx. 4 months)
Primary	Visual Analog Satisfaction Scale	A measure of acceptability of the intervention. Target mean score is 75% or greater.	after intervention completion, up to 8 weeks post-randomization
Primary	Number of Participant Clicks on Study Website	A usability measure obtained using Google Analytics.	baseline, end of study (approx. 4 months)
Secondary	Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale	Depression symptoms were assessed with the PHQ-9, a 9-item scale (range 0 [no distress] to 27 [high distress]); symptom severity is interpreted as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).	Between randomization and 3 months post-randomization
Secondary	Change in Distress Associated With Physical Symptoms	The PHQ-10 (Patient Health Questionnaire) was used to measure distress associated with physical symptoms (range 0 [none] to 30 [very troublesome]).	Between randomization and 3 months post-randomization
Secondary	Change in Mindfulness Skills	Mindfulness skills were measured with the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), a 12-item measure of mindful qualities (range 12 [low ability] to 48 [highest ability]).	Between randomization and 3 months post-randomization
Secondary	Change in Psychological Distress Symptoms as Measured by the GAD-7	Anxiety symptoms were measured using the Generalized Anxiety Disorder 7-item scale (GAD-7; range 0 [no distress] to 21 [high distress]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21).	Between randomization and 3 months post-randomization
Secondary	Change in Psychological Distress Symptoms as Measured by the PTSS	The Post Traumatic Stress Scale (PTSS), a 10-item scale (range 10 [no symptoms] to 70 [high burden of symptoms]), was used to assess PTSD symptoms; >20 represents clinically important symptoms.	Between randomization and 3 months post-randomization
Secondary	Change in the Avoidance Domain of the Brief COPE Scale	Coping skills were measured with the Brief COPE scale (range 10 [low use] to 40 [highest use]). The Brief COPE is a self-report questionnaire used to assess a number of different coping behaviors and thoughts a person may have in response to a specific situation.	Between randomization and 3 months post-randomization