Psychological DistressNCT02701361
Mobile Mindfulness to Improve Psychological Distress After Critical Illness
A study testing mobile mindfulness, standard mindfulness and education in people with Psychological Distress and Depression, run by Duke University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Depression, Anxiety
- What is being tested?
- mobile mindfulness, standard mindfulness and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2016to 5 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27710
University of Washington
Seattle, Washington, 98195
About this study
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.
Read the 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
- Being tested
- mobile mindfulness, standard mindfulness, education
- Keywords
- mindfulness, critical illness, intensive care unit, mindfulness-based stress reduction
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile mindfulnessBehavioural
Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.
standard mindfulnessBehavioural
Receives weekly calls from mindfulness expert for 4 weeks.
educationBehavioural
Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.
| Study group | Role | What they receive |
|---|---|---|
| Education group | Active comparator | 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. Receives: Behavioral: education |
| Standard mindfulness | Experimental | Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert. Receives: Behavioral: standard mindfulness |
| Mobile mindfulness | Experimental | 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. Receives: Behavioral: mobile mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: pre-randomization
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%.
Measured: randomization
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.
Measured: 1 month post-randomization
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.
Measured: 1 month post-randomization
Percent of Randomized Participants Who Drop Out of Study
A feasibility measure. Target is 20% or less.
Measured: baseline, end of study (approx. 4 months)
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%.
Measured: baseline, end of study (approx. 4 months)
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.
Measured: baseline, end of study (approx. 4 months)
Percentage of Self-directed MBT Sessions Attended by Eligible Participants
A feasibility measure. Target is 50% among those who neither dropped out nor died.
Measured: baseline, end of study (approx. 4 months)
Visual Analog Satisfaction Scale
A measure of acceptability of the intervention. Target mean score is 75% or greater.
Measured: after intervention completion, up to 8 weeks post-randomization
Number of Participant Clicks on Study Website
A usability measure obtained using Google Analytics.
Measured: baseline, end of study (approx. 4 months)
Secondary outcomes (6)
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).
Measured: Between randomization and 3 months post-randomization
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]).
Measured: Between randomization and 3 months post-randomization
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]).
Measured: Between randomization and 3 months post-randomization
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).
Measured: Between randomization and 3 months post-randomization
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.
Measured: Between randomization and 3 months post-randomization
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.
Measured: Between randomization and 3 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion1 May 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Pennsylvania, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Christopher E Cox, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701361
- Sponsor's protocol ID
- Pro00064250
- Other IDs
- R34AT008819
- Status last verified
- Jan 2018
- First submitted
- 24 Feb 2016
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24303911Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. 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. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.
PubMed 29793970
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Mindfulness to Improve Psychological Distress After Critical Illness
- ClinicalTrials.gov ID
- NCT02701361
- Acronym / sponsor ID
- Pro00064250
- Conditions
- Psychological Distress, Depression, Anxiety, Post-traumatic Stress Disorder, Informal Caregivers, Family Members
- Keywords
- mindfulness, critical illness, intensive care unit, mindfulness-based stress reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Washington, University of Pennsylvania, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 10 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education group | Active comparator | Behavioral: educationA 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. |
| Standard mindfulness | Experimental | Behavioral: standard mindfulnessReceives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert. |
| Mobile mindfulness | Experimental | Behavioral: mobile mindfulnessReceives 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile mindfulnessReceives audiovisual mindfulness content via internet plus call depending on symptoms or request. | Behavioural | Mobile mindfulness |
| standard mindfulnessReceives weekly calls from mindfulness expert for 4 weeks. | Behavioural | Standard mindfulness |
| educationReceives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials. | Behavioural | Education group |
Primary outcome
Percent of Eligible Participants Who Provided Consent
Time frame: 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
Time frame: randomization
Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.
Client Satisfaction Questionnaire (CSQ) Score
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: after intervention completion, up to 8 weeks post-randomization
A measure of acceptability of the intervention. Target mean score is 75% or greater.
Number of Participant Clicks on Study Website
Time frame: baseline, end of study (approx. 4 months)
A usability measure obtained using Google Analytics.
6 secondary outcomes
Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale
Time frame: Between randomization and 3 months post-randomization
Change in Distress Associated With Physical Symptoms
Time frame: Between randomization and 3 months post-randomization
Change in Mindfulness Skills
Time frame: Between randomization and 3 months post-randomization
Change in Psychological Distress Symptoms as Measured by the GAD-7
Time frame: Between randomization and 3 months post-randomization
Change in Psychological Distress Symptoms as Measured by the PTSS
Time frame: Between randomization and 3 months post-randomization
Change in the Avoidance Domain of the Brief COPE Scale
Time frame: Between randomization and 3 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24303911Cox 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.
- Derived from this study: PubMed 29793970Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. 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. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Cox, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile mindfulness, standard mindfulness and education in people with Psychological Distress and Depression, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Eligible Participants Who Provided Consent (time frame: pre-randomization). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701361, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.