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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AT009974 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| University of Colorado, Denver | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. This will allow optimization of a mobile mindfulness intervention by comparing eight different iterations across domains including impact on symptoms, feasibility, acceptability, usability, scalability, and cost.
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of psychological distress including depression, anxiety, and post-traumatic stress disorder (PTSD). However, few targeted interventions exist that are relevant to patients' experiences and that accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, an innovative app-based mobile mindfulness training program twas developed hat promotes automated care delivery and self-management of symptom-related distress.
Subsequently, a pilot randomized clinical trial (RCT) called the LIFT study (R34 AT00819) compared mobile mindfulness to both a standard telephone mindfulness program and an ICU education control among survivors of cardiorespiratory failure. Key findings were that mobile mindfulness was feasibly delivered, acceptable, usable, and had a greater clinical impact on psychological distress than either comparator. This trial also highlighted opportunities to improve the intervention's impact related to its targeted population, content delivery, and system technology.
To address these gaps, this 5-year project is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. It will optimize mobile mindfulness with four specific aims as described in the following sections. At the conclusion of this factorial randomized clinical trial study involving 240 cardiorespiratory failure survivors, a mobile mindfulness system fully optimized for usability, efficiency, scalability, and clinical impact will be delivered that will be off-the-shelf ready for a next-step definitive RCT-and can serve as a model for distance-based mind and body interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App introduction to intervention | Other | Introduction to intervention via the mobile app itself. |
|
| Therapist introduction to intervention | Other | Introduction to intervention via a call from the study therapist. |
|
| Standard dose | Other | Standard dose of meditation time (once a day). |
|
| High dose | Other | High dose of meditation time (twice a day). |
|
| App response to symptoms | Other | Mobile app response to elevated psychological distress symptoms during intervention period. |
|
| Therapist response to symptoms | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile mindfulness-based training | Behavioral | The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 6 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 Item Scale (PHQ-9) | Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse) | 1 month post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse) | Between baseline 1 month post-randomization |
| Patient Health Questionnaire-9 Item Scale (PHQ-9) |
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INCLUSION CRITERIA
Adult (age ≥18)
Acute cardiorespiratory failure:
Managed in an adult medical cardiac, trauma, surgical, or neurological ICU, stepdown unit, or monitored ward unit for ≥24 hours during the time inclusion criterion #2 is met.
Cognitive status intact
Absence of severe and/or persistent mental illness
English fluency.
EXCLUSION CRITERIA (in hospital):
Hospitalized within the preceding 3 months with life-threatening illness or injury.
Patients may be enrolled into the study if they had a hospitalization within the preceding 3 months that is determined to be non-serious. Non-serious admissions are defined as those admissions that are non-life threatening and/or potentially impacting patient's well-being long-term or likely to precipitate additional future admissions. Examples of non-life-threatening hospitalizations could be, but may not be limited to, admission for a bronchoscopy, admission for deep vein thrombosis, or admission to ED resulting in overnight stay for cardiac work-up.
Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice)
Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
Unable to complete study procedures as determined by staff
Lack of reliable smartphone with cellular data plan or wifi access
EXCLUSION CRITERIA (at T1, post-discharge):
Low baseline psychological distress symptoms, defined as the absence of the following at T1: PHQ-9 score <5
Failure to randomize within 2 month (60 days) post-discharge.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher E Cox, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado - Denver | Aurora | Colorado | 80045 | United States | ||
| Duke University Medical Center |
| 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 | Background | 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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We will follow NIH/NCCIH guidelines for data access.
We will follow NIH and institutional guidelines.
We will follow NIH and institutional guidelines. Given the length of time that will elapse during the study, we will need to adhere to the rules present at that time.
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Note that this is a factorial experimental trial in which 3 factors were examined, each at 2 levels (i.e., a 2^3 design).
In this trial the 3 factors and 2 levels are as follows:
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| ID | Title | Description |
|---|---|---|
| FG000 | App Introduction to Intervention, High Dose, and Therapist Response | Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| FG001 | Therapist Introduction to Intervention, High Dose, and Therapist Response | Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| FG002 | App Introduction to Intervention, Standard Dose, and Therapist Response | Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| FG003 | Therapist Introduction to Intervention, Standard Dose, and Therapist Response | Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| FG004 | App Introduction to Intervention, High Dose, and App Response | Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period. |
| FG005 | Therapist Introduction to Intervention, High Dose, and App Response | Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period. |
| FG006 | App Introduction to Intervention, Standard Dose, and App Response | Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period. |
| FG007 | Therapist Introduction to Intervention, Standard Dose, and App Response | Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | App Introduction to Intervention, High Dose, and Therapist Response | Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| BG001 | Therapist Introduction to Intervention, High Dose, and Therapist Response |
| 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 | Patient Health Questionnaire-9 Item Scale (PHQ-9) | Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse) | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | 1 month post-randomization |
|
3 months
Adverse events:
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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 | App Introduction to Intervention, High Dose, and Therapist Response | Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation (per PHQ-9 item 9) | Psychiatric disorders | Systematic Assessment | Anyone responding to PHQ-9 item 9 with a response other than '0' to question regarding suicidal ideation. This survey was done 5-6 times on every participant during the trial, so it is a sum of all these events. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Cox | Duke University | 919-681-7232 | 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2020 | Nov 15, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2023 | Dec 7, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2021 | Mar 27, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design
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PIs and analysts blinded to allocation. Outcomes completed by participants using web-based interface and thus outcomes assessors as such are blinded.
Therapist call in response to elevated psychological distress symptoms during intervention period.
|
|
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
| Between baseline 3 months post-randomization |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse) | Between baseline 3 months post-randomization |
| Post-Traumatic Stress Symptom Inventory (PTSS) | Absolute values, not change scores. PTSD symptoms. Scores can range from 10 (best) to 70 (worst). | Between baseline 3 months post-randomization |
| Intervention Adherence: Activity in App During Final Week of Intervention | Quantified by number with activity (or not) in app during final week (4) of intervention | 1 month post-randomization |
| Intervention Adherence: Number of Views of Content | Quantified by mean (SD) number of intervention content (audio, video, text) views | 1 month post-randomization |
| Client Satisfaction Questionnaire (CSQ) | A measure of acceptability. Scores can range from 8 (worst) to 32 (best) | 3 months post-randomization |
| Systems Usability Scale (SUS) | A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best) | 3 months post-randomization |
| Mindful Attention Awareness Scale (MAAS) | This is the absolute value, not change score. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best). | Between baseline and 1 month post-randomization |
| Mindful Attention Awareness Scale (MAAS) | These are absolute values, not change scores. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best). | Between baseline 3 months post-randomization |
| Patient Health Questionnaire 10-item Scale (PHQ-10) | These are absolute values, not change scores. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst). | Between baseline and 1 month post-randomization |
| Patient Health Questionnaire 10-item Scale (PHQ-10) | This is an absolute value, not a change score. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst). | Between baseline 3 months post-randomization |
| EuroQOL Scale | This is an absolute, not change, value. the EuroQOL is a measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Between baseline and 1 month post-randomization |
| Change in EuroQOL Scale | A measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Between baseline 3 months post-randomization |
| Distress Associated With Depression Symptom Frequency | A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst) | Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED |
| Distress Associated With Depression Symptom Frequency | A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst) | At 1 month post-randomization |
| Distress Associated With Anxiety Symptom Frequency | A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst) | At 1 month post-randomization |
| Distress Associated With Anxiety Symptom Frequency | A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst) | Between baseline 3 months post-randomization |
| Distress Associated With PTSD Symptom Frequency | A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst) | At 1 month post-randomization |
| Distress Associated With PTSD Symptom Frequency | Absolute values, not change scores. A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst) | At 3 months post-randomization |
| Post-Traumatic Stress Symptom Inventory (PTSS) | Absolute values, not change scores. Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst). | Between baseline and 1 month post-randomization |
| Client Satisfaction Questionnaire (CSQ) | A measure of acceptability. Scores can range from 8 (worst) to 32 (best) | 1 month post-randomization |
| Systems Usability Scale (SUS) | A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best) | 1 month post-randomization |
| Durham |
| North Carolina |
| 27710 |
| United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| 32805434 | Background | Cox CE, Olsen MK, Gallis JA, Porter LS, Greeson JM, Gremore T, Frear A, Ungar A, McKeehan J, McDowell B, McDaniel H, Moss M, Hough CL. Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial. Contemp Clin Trials. 2020 Sep;96:106119. doi: 10.1016/j.cct.2020.106119. Epub 2020 Aug 15. |
| 38805199 | Derived | Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823. |
| Withdrawal by Subject |
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| missed survey window |
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| technical issues |
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| Medical issues (i.e., illness) |
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| Death |
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Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| BG002 | App Introduction to Intervention, Standard Dose, and Therapist Response | Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| BG003 | Therapist Introduction to Intervention, Standard Dose, and Therapist Response | Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period. |
| BG004 | App Introduction to Intervention, High Dose, and App Response | Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period. |
| BG005 | Therapist Introduction to Intervention, High Dose, and App Response | Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period. |
| BG006 | App Introduction to Intervention, Standard Dose, and App Response | Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period. |
| BG007 | Therapist Introduction to Intervention, Standard Dose, and App Response | Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period. |
| BG008 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Standard Dose |
Standard dose of meditation time (once a day). |
| OG003 | High Dose | High dose of meditation time (twice a day). |
| OG004 | App Response | Mobile app response to elevated psychological distress symptoms during intervention period. |
| OG005 | Therapist Response | Therapist call in response to elevated psychological distress symptoms during intervention period. |
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| Secondary | Generalized Anxiety Disorder 7-item Scale (GAD-7) | Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse) | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline 1 month post-randomization |
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| Secondary | Patient Health Questionnaire-9 Item Scale (PHQ-9) | Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse) | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline 3 months post-randomization |
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| Secondary | Generalized Anxiety Disorder 7-item Scale (GAD-7) | Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse) | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline 3 months post-randomization |
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| Secondary | Post-Traumatic Stress Symptom Inventory (PTSS) | Absolute values, not change scores. PTSD symptoms. Scores can range from 10 (best) to 70 (worst). | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline 3 months post-randomization |
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| Secondary | Intervention Adherence: Activity in App During Final Week of Intervention | Quantified by number with activity (or not) in app during final week (4) of intervention | Posted | Count of Participants | Participants | 1 month post-randomization |
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| Secondary | Intervention Adherence: Number of Views of Content | Quantified by mean (SD) number of intervention content (audio, video, text) views | Posted | Mean | Standard Deviation | mobile app content views | 1 month post-randomization |
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| Secondary | Client Satisfaction Questionnaire (CSQ) | A measure of acceptability. Scores can range from 8 (worst) to 32 (best) | Data not collected. | Posted | 3 months post-randomization |
|
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| Secondary | Systems Usability Scale (SUS) | A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best) | Data not collected. | Posted | 3 months post-randomization |
|
|
| Secondary | Mindful Attention Awareness Scale (MAAS) | This is the absolute value, not change score. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best). | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline and 1 month post-randomization |
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| Secondary | Mindful Attention Awareness Scale (MAAS) | These are absolute values, not change scores. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best). | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline 3 months post-randomization |
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| Secondary | Patient Health Questionnaire 10-item Scale (PHQ-10) | These are absolute values, not change scores. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst). | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline and 1 month post-randomization |
|
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| Secondary | Patient Health Questionnaire 10-item Scale (PHQ-10) | This is an absolute value, not a change score. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst). | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline 3 months post-randomization |
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|
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| Secondary | EuroQOL Scale | This is an absolute, not change, value. the EuroQOL is a measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline and 1 month post-randomization |
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| Secondary | Change in EuroQOL Scale | A measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline 3 months post-randomization |
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| Secondary | Distress Associated With Depression Symptom Frequency | A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst) | Data were not collected | Posted | Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED |
|
|
| Secondary | Distress Associated With Depression Symptom Frequency | A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst) | Posted | Mean | Standard Deviation | units on a scale | At 1 month post-randomization |
|
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| Secondary | Distress Associated With Anxiety Symptom Frequency | A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst) | Posted | Mean | Standard Deviation | units on a scale | At 1 month post-randomization |
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| Secondary | Distress Associated With Anxiety Symptom Frequency | A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst) | Data were not collected | Posted | Between baseline 3 months post-randomization |
|
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| Secondary | Distress Associated With PTSD Symptom Frequency | A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst) | Posted | Mean | Standard Deviation | units on a scale | At 1 month post-randomization |
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| Secondary | Distress Associated With PTSD Symptom Frequency | Absolute values, not change scores. A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst) | Data were not collected | Posted | At 3 months post-randomization |
|
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| Secondary | Post-Traumatic Stress Symptom Inventory (PTSS) | Absolute values, not change scores. Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst). | Participants who had data collected at both time points. | Posted | Mean | Standard Deviation | units on a scale | Between baseline and 1 month post-randomization |
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| Secondary | Client Satisfaction Questionnaire (CSQ) | A measure of acceptability. Scores can range from 8 (worst) to 32 (best) | Posted | Mean | Standard Deviation | units on a scale | 1 month post-randomization |
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| Secondary | Systems Usability Scale (SUS) | A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score. For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best) | Data not collected. | Posted | 1 month post-randomization |
|
|
| 0 |
| 30 |
| 6 |
| 30 |
| 0 |
| 30 |
| EG001 | Therapist Introduction to Intervention, High Dose, and Therapist Response | Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Therapist call in response to elevated psychological distress symptoms during intervention period. | 0 | 31 | 4 | 31 | 1 | 31 |
| EG002 | App Introduction to Intervention, Standard Dose, and Therapist Response | Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period. | 0 | 31 | 1 | 31 | 1 | 31 |
| EG003 | Therapist Introduction to Intervention, Standard Dose, and Therapist Response | Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Therapist call in response to elevated psychological distress symptoms during intervention period. | 1 | 32 | 2 | 32 | 1 | 32 |
| EG004 | App Introduction to Intervention, High Dose, and App Response | Introduction to intervention via the mobile app itself. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period. | 1 | 32 | 3 | 32 | 1 | 32 |
| EG005 | Therapist Introduction to Intervention, High Dose, and App Response | Introduction to intervention via a call from the study therapist. High dose of meditation time (twice a day). Mobile app response to elevated psychological distress symptoms during intervention period. | 0 | 31 | 5 | 31 | 1 | 31 |
| EG006 | App Introduction to Intervention, Standard Dose, and App Response | Introduction to intervention via the mobile app itself. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period. | 0 | 30 | 2 | 30 | 1 | 30 |
| EG007 | Therapist Introduction to Intervention, Standard Dose, and App Response | Introduction to intervention via a call from the study therapist. Standard dose of meditation time (once a day). Mobile app response to elevated psychological distress symptoms during intervention period. | 1 | 30 | 2 | 30 | 2 | 30 |
|
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Not provided
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| -0.82 |
| 2-Sided |
| 95 |
| -1.80 |
| 1.49 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | 0.51 | 2-Sided | 95 | -0.48 | 1.49 | Superiority |
Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| -1.47 |
| 2-Sided |
| 95 |
| -2.81 |
| -0.14 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response to symptoms. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | 0.82 | 2-Sided | 95 | -0.52 | 2.15 | Superiority |
| Mean Difference (Final Values) |
| -1.22 |
| 2-Sided |
| 95 |
| -2.29 |
| -0.15 |
| Superiority |
| Mean Difference (Final Values) | -0.70 | 2-Sided | 95 | -1.77 | 0.37 | Superiority |
Values are change in model-estimated means for hig vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| -0.42 |
| 2-Sided |
| 95 |
| -3.26 |
| 2.42 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | 1.49 | 2-Sided | 95 | -1.35 | 4.33 | Superiority |
Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| 0.73 |
| 2-Sided |
| 95 |
| -0.47 |
| 1.92 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | 0.19 | 2-Sided | 95 | -1.00 | 1.39 | Superiority |
Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| 0.02 |
| 2-Sided |
| 95 |
| -1.33 |
| 1.38 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | -0.36 | 2-Sided | 95 | -1.72 | 0.99 | Superiority |
Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| -0.53 |
| 2-Sided |
| 95 |
| -1.33 |
| 0.27 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | 0.25 | 2-Sided | 95 | -.55 | 1.05 | Superiority |
| Mean Difference (Final Values) |
| -0.36 |
| 2-Sided |
| 95 |
| -1.27 |
| 0.55 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | 0.51 | 2-Sided | 95 | -0.40 | 1.42 | Superiority |
Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| 4.82 |
| 2-Sided |
| 95 |
| -0.76 |
| 10.40 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | -0.02 | 2-Sided | 95 | -5.60 | 5.56 | Superiority |
Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| 1.28 |
| 2-Sided |
| 95 |
| -4.92 |
| 7.47 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | 0.11 | 2-Sided | 95 | -6.09 | 6.30 | Superiority |
Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). |
| Mean Difference (Final Values) |
| -1.89 |
| 2-Sided |
| 95 |
| -4.46 |
| 0.67 |
| Superiority |
| Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist [1] vs app [-1]), dose (high [1] vs low [-1]), and symptom management (therapist [1] vs app [-1]). | Mean Difference (Final Values) | -0.74 | 2-Sided | 95 | -3.31 | 1.83 | Superiority |