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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT008819 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| University of Pennsylvania | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard mindfulness | Experimental | Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile mindfulness | Behavioral | Receives audiovisual mindfulness content via internet plus call depending on symptoms or request. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Percent of Randomized Participants Who Drop Out of Study | A feasibility measure. Target is 20% or less. | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability Themes Developed From Semi-structured Participant Interviews | A usability measure. Open-ended feedback questions will be arranged in themes. | end of study |
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)
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
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:
Other issues relevant to the consent process:
Patient exclusion criteria present after consent but before randomization:
After providing informed consent, patients will become ineligible if any of the following are present:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher E Cox, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24303911 | Background | 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. | |
| 29793970 | Derived | Cox 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. |
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90 participants signed consent; 2 participants who signed consent were later found not to be eligible(88 eligible). 80 participants were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | 121, not 90 subjects, are analyzed because this outcome measure applies to a pre-consent and pre-randomization time period. | Posted | Count of Participants | Participants | pre-randomization |
|
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Cox | Duke University Health System | 9196817232 | christopher.cox@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 9, 2016 | Oct 30, 2017 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 14, 2016 | Oct 30, 2017 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2016 | Jan 11, 2018 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| standard mindfulness | Behavioral | Receives weekly calls from mindfulness expert for 4 weeks. |
|
| education | Behavioral | Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials. |
|
| 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. | 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. | 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. | after intervention completion, up to 8 weeks post-randomization |
| Number of Participant Clicks on Study Website | A usability measure obtained using Google Analytics. | baseline, end of study (approx. 4 months) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Seattle |
| Washington |
| 98195 |
| United States |
| timed out in rehab center |
|
| incarceration |
|
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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%. | Following consent, two participants were found to be ineligible. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Median | Standard Deviation | units on a scale | 1 month post-randomization |
|
|
|
| Primary | Percent of Randomized Participants Who Drop Out of Study | A feasibility measure. Target is 20% or less. | Posted | Count of Participants | Participants | 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%. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | measure was mistakenly omitted from study CRF and therefore data not collected. | Posted | after intervention completion, up to 8 weeks post-randomization |
|
|
| Primary | Number of Participant Clicks on Study Website | A usability measure obtained using Google Analytics. | Posted | Mean | Standard Deviation | clicks | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 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]). | Posted | Mean | 95% Confidence Interval | units on a scale | 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]). | Posted | Mean | 95% Confidence Interval | units on a scale | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Between randomization and 3 months post-randomization |
|
|
|
| Other Pre-specified | Usability Themes Developed From Semi-structured Participant Interviews | A usability measure. Open-ended feedback questions will be arranged in themes. | Not Posted | end of study | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Standard Mindfulness | Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D000068099 |
| Trauma and Stressor Related Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|