Mobile Mindfulness to Improve Psychological Distress After Critical Illness

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02701361

Enrollment

Registered

2016-03-08

Start date

2016-03-31

Completion date

2017-07-05

Last updated

2018-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

mindfulness, critical illness, intensive care unit, mindfulness-based stress reduction

Brief 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.

Interventions

BEHAVIORALmobile mindfulness

Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.

BEHAVIORALstandard mindfulness

Receives weekly calls from mindfulness expert for 4 weeks.

BEHAVIORALeducation

Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participant Clicks on Study Website	baseline, end of study (approx. 4 months)	A usability measure obtained using Google Analytics.
Client Satisfaction Questionnaire (CSQ) Score	1 month post-randomization	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.
System Usability Scale (SUS)	1 month post-randomization	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.
Percent of Randomized Participants Who Drop Out of Study	baseline, end of study (approx. 4 months)	A feasibility measure. Target is 20% or less.
Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews	baseline, end of study (approx. 4 months)	Percent of participants who have neither dropped out nor died who complete telephone interviews. A feasibility measure. Target is 75%.
Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys	baseline, end of study (approx. 4 months)	A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.
Percentage of Self-directed MBT Sessions Attended by Eligible Participants	baseline, end of study (approx. 4 months)	A feasibility measure. Target is 50% among those who neither dropped out nor died.
Visual Analog Satisfaction Scale	after intervention completion, up to 8 weeks post-randomization	A measure of acceptability of the intervention. Target mean score is 75% or greater.
Percent of Eligible Participants Who Provided Consent	pre-randomization	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%.
Percent of Eligible Participants Who Provide Informed Consent and Were Randomized	randomization	Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.

Secondary

Measure	Time frame	Description
Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale	Between randomization and 3 months post-randomization	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).
Change in Distress Associated With Physical Symptoms	Between randomization and 3 months post-randomization	The PHQ-10 (Patient Health Questionnaire) was used to measure distress associated with physical symptoms (range 0 \[none\] to 30 \[very troublesome\]).
Change in Mindfulness Skills	Between randomization and 3 months post-randomization	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 \[highest ability\]).
Change in Psychological Distress Symptoms as Measured by the GAD-7	Between randomization and 3 months post-randomization	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).
Change in Psychological Distress Symptoms as Measured by the PTSS	Between randomization and 3 months post-randomization	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.
Change in the Avoidance Domain of the Brief COPE Scale	Between randomization and 3 months post-randomization	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.

Other

Measure	Time frame	Description
Usability Themes Developed From Semi-structured Participant Interviews	end of study	A usability measure. Open-ended feedback questions will be arranged in themes.

Countries

United States

Participant flow

Recruitment details

90 participants signed consent; 2 participants who signed consent were later found not to be eligible(88 eligible). 80 participants were randomized

Participants by arm

Arm	Count
Mobile Mindfulness 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. mobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.	31
Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert. standard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks.	31
Education Group 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. education: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.	18
Total	80

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	incarceration	0	0	1
Overall Study	Lost to Follow-up	5	2	1
Overall Study	timed out in rehab center	0	1	0
Overall Study	Withdrawal by Subject	4	0	0

Baseline characteristics

Characteristic	Mobile Mindfulness	Standard Mindfulness	Education Group	Total
Age, Continuous	48.7 years STANDARD_DEVIATION 15.3	48.1 years STANDARD_DEVIATION 16.1	53.3 years STANDARD_DEVIATION 12.6	49.5 years STANDARD_DEVIATION 15.1
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants	30 Participants	18 Participants	79 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	0 Participants	2 Participants	4 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	4 Participants	9 Participants	5 Participants	18 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	1 Participants	3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	23 Participants	20 Participants	10 Participants	53 Participants
Sex: Female, Male Female	12 Participants	15 Participants	8 Participants	35 Participants
Sex: Female, Male Male	19 Participants	16 Participants	10 Participants	45 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 31	0 / 31	0 / 18
other Total, other adverse events	0 / 31	0 / 31	0 / 18
serious Total, serious adverse events	0 / 31	0 / 31	0 / 18

Outcome results

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.

Time frame: 1 month post-randomization

Arm	Measure	Value (MEAN)	Dispersion
All Eligible Subjects Approached to Participate in the Study	Client Satisfaction Questionnaire (CSQ) Score	27.6 units on a scale	Standard Deviation 3.8
Standard Mindfulness	Client Satisfaction Questionnaire (CSQ) Score	29.4 units on a scale	Standard Deviation 3.3
Education Group	Client Satisfaction Questionnaire (CSQ) Score	25.7 units on a scale	Standard Deviation 3.2

Primary

Number of Participant Clicks on Study Website

A usability measure obtained using Google Analytics.

Time frame: baseline, end of study (approx. 4 months)

Arm	Measure	Value (MEAN)	Dispersion
All Eligible Subjects Approached to Participate in the Study	Number of Participant Clicks on Study Website	188.4 clicks	Standard Deviation 220.8

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.

Time frame: baseline, end of study (approx. 4 months)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Eligible Subjects Approached to Participate in the Study	Percentage of Self-directed MBT Sessions Attended by Eligible Participants	22 Participants

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%.

Time frame: pre-randomization

Population: 121, not 90 subjects, are analyzed because this outcome measure applies to a pre-consent and pre-randomization time period.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Eligible Subjects Approached to Participate in the Study	Percent of Eligible Participants Who Provided Consent	90 Participants

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%.

Time frame: randomization

Population: Following consent, two participants were found to be ineligible.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Eligible Subjects Approached to Participate in the Study	Percent of Eligible Participants Who Provide Informed Consent and Were Randomized	80 Participants

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.

Time frame: baseline, end of study (approx. 4 months)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Eligible Subjects Approached to Participate in the Study	Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys	17 Participants

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%.

Time frame: baseline, end of study (approx. 4 months)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
All Eligible Subjects Approached to Participate in the Study	Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews	22 Participants
Standard Mindfulness	Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews	28 Participants
Education Group	Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews	16 Participants

Primary

Percent of Randomized Participants Who Drop Out of Study

A feasibility measure. Target is 20% or less.

Time frame: baseline, end of study (approx. 4 months)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
All Eligible Subjects Approached to Participate in the Study	Percent of Randomized Participants Who Drop Out of Study	before intervention initiated	7 Participants
All Eligible Subjects Approached to Participate in the Study	Percent of Randomized Participants Who Drop Out of Study	after intervention initiated	2 Participants
Standard Mindfulness	Percent of Randomized Participants Who Drop Out of Study	before intervention initiated	2 Participants
Standard Mindfulness	Percent of Randomized Participants Who Drop Out of Study	after intervention initiated	1 Participants
Education Group	Percent of Randomized Participants Who Drop Out of Study	before intervention initiated	0 Participants
Education Group	Percent of Randomized Participants Who Drop Out of Study	after intervention initiated	2 Participants

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.

Time frame: 1 month post-randomization

Arm	Measure	Value (MEDIAN)	Dispersion
All Eligible Subjects Approached to Participate in the Study	System Usability Scale (SUS)	86.5 units on a scale	Standard Deviation 13.3

Primary

Visual Analog Satisfaction Scale

A measure of acceptability of the intervention. Target mean score is 75% or greater.

Time frame: after intervention completion, up to 8 weeks post-randomization

Population: measure was mistakenly omitted from study CRF and therefore data not collected.

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 \[very troublesome\]).