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Mobile Mindfulness to Improve Psychological Distress After Critical Illness

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ClinicalTrials.gov Identifier: NCT02701361
Recruitment Status : Completed
First Posted : March 8, 2016
Results First Posted : January 10, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
University of Washington
University of Pennsylvania
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Psychological Distress Depression Anxiety Post-traumatic Stress Disorder Informal Caregivers Family Members Behavioral: mobile mindfulness Behavioral: standard mindfulness Behavioral: education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mobile Mindfulness to Improve Psychological Distress After Critical Illness
Actual Study Start Date : March 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : July 5, 2017

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: education
Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.

Experimental: Standard mindfulness
Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
Behavioral: standard mindfulness
Receives weekly calls from mindfulness expert for 4 weeks.

Experimental: 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.
Behavioral: mobile mindfulness
Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.




Primary Outcome Measures :
  1. 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%.

  2. 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%.

  3. 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.

  4. 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.

  5. 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.

  6. 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%.

  7. 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.

  8. 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.

  9. 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.

  10. Number of Participant Clicks on Study Website [ Time Frame: baseline, end of study (approx. 4 months) ]
    A usability measure obtained using Google Analytics.


Secondary Outcome Measures :
  1. Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale [ Time Frame: 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).

  2. Change in Distress Associated With Physical Symptoms [ Time Frame: 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]).

  3. Change in Mindfulness Skills [ Time Frame: 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]).

  4. Change in Psychological Distress Symptoms as Measured by the GAD-7 [ Time Frame: 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).

  5. Change in Psychological Distress Symptoms as Measured by the PTSS [ Time Frame: 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.

  6. Change in the Avoidance Domain of the Brief COPE Scale [ Time Frame: 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 Outcome Measures:
  1. Usability Themes Developed From Semi-structured Participant Interviews [ Time Frame: end of study ]
    A usability measure. Open-ended feedback questions will be arranged in themes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701361


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Duke University
University of Washington
University of Pennsylvania
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Christopher E Cox, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Informed Consent Form  [PDF] May 9, 2016
Study Protocol  [PDF] October 14, 2016
Statistical Analysis Plan  [PDF] May 9, 2016

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02701361    
Other Study ID Numbers: Pro00064250
R34AT008819 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2016    Key Record Dates
Results First Posted: January 10, 2018
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Duke University:
mindfulness
critical illness
intensive care unit
mindfulness-based stress reduction
Additional relevant MeSH terms:
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Critical Illness
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Disease Attributes
Pathologic Processes