Cardiorespiratory Failure
Conditions
Keywords
cardiorespiratory failure, critical illness, psychological distress, depression, anxiety, post-traumatic stress disorder, intensive care units, adults, mechanical ventilation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMobile mindfulness-based training
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.
Sponsors
University of Washington
University of Colorado, Denver
National Center for Complementary and Integrative Health (NCCIH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
PIs and analysts blinded to allocation. Outcomes completed by participants using web-based interface and thus outcomes assessors as such are blinded.
Intervention model description
Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult (age ≥18) 2. Acute cardiorespiratory failure: * Acute respiratory failure, defined as ≥1 of the following: * 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 oxygen for ≥4 hours in a 24-hour period and / or * Acute cardiac / circulatory failure, defined as ≥1 of the following: * use of vasopressors for shock of any etiology for ≥1 hour * use of inotropes for shock of any etiology for ≥1 hour * use of pulmonary vascular vasoactive medications * use of aortic balloon pump for cardiogenic shock for ≥1 hour 3. 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. 4. Cognitive status intact * No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart * Absence of current significant cognitive impairment (impairment defined as ≥3 errors on the Callahan cognitive status screen) * Decisional capacity present 5. Absence of severe and/or persistent mental illness * Treatment for severe and/or persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia \[as per medical record\], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission * No endorsement of suicidality at time of admission or informed consent * No active substance abuse within the 3 months preceding the current admission serious enough to limit completion of study procedures in the opinion of the site investigator. 6. English fluency.
Exclusion criteria
(in hospital): 1. 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. 2. Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility) 3. 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) 4. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen) 5. Unable to complete study procedures as determined by staff 6. Lack of reliable smartphone with cellular data plan or wifi access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 Item Scale (PHQ-9) | 1 month post-randomization | Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 Item Scale (PHQ-9) | Between baseline 3 months post-randomization | Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse) |
| Post-Traumatic Stress Symptom Inventory (PTSS) | Between baseline 3 months post-randomization | Absolute values, not change scores. PTSD symptoms. Scores can range from 10 (best) to 70 (worst). |
| Intervention Adherence: Activity in App During Final Week of Intervention | 1 month post-randomization | Quantified by number with activity (or not) in app during final week (4) of intervention |
| Intervention Adherence: Number of Views of Content | 1 month post-randomization | Quantified by mean (SD) number of intervention content (audio, video, text) views |
| Client Satisfaction Questionnaire (CSQ) | 3 months post-randomization | A measure of acceptability. Scores can range from 8 (worst) to 32 (best) |
| Systems Usability Scale (SUS) | 3 months post-randomization | 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) |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | Between baseline 1 month post-randomization | Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse) |
| Patient Health Questionnaire 10-item Scale (PHQ-10) | Between baseline and 1 month post-randomization | 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). |
| EuroQOL Scale | Between baseline and 1 month post-randomization | 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) |
| Change in EuroQOL Scale | Between baseline 3 months post-randomization | A measure of quality of life. Scores can range from 0 (worst) to 100 (best) |
| Distress Associated With Depression Symptom Frequency | Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED | 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) |
| Distress Associated With Anxiety Symptom Frequency | At 1 month post-randomization | 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) |
| Distress Associated With PTSD Symptom Frequency | At 1 month post-randomization | 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) |
| Mindful Attention Awareness Scale (MAAS) | Between baseline and 1 month post-randomization | This is the absolute value, not change score. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best). |
Countries
United States
Participant flow
Recruitment details
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: 1. Introduction to intervention (app introduction vs. therapist introduction) 2. Dose (standard vs. high) 3. Response to depression symptoms that increase during the intervention period (app response vs. therapist response)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 31 |
| 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. | 31 |
| 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. | 32 |
| 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. | 32 |
| 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. | 31 |
| 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. | 30 |
| 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. | 30 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 6 | 4 | 5 | 4 | 6 | 4 | 4 | 1 |
| Overall Study | Medical issues (i.e., illness) | 0 | 1 | 2 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | missed survey window | 1 | 2 | 0 | 0 | 1 | 1 | 2 | 2 |
| Overall Study | technical issues | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 | 1 | 4 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Therapist Introduction to Intervention, High Dose, and Therapist Response | App Introduction to Intervention, Standard Dose, and Therapist Response | Therapist Introduction to Intervention, Standard Dose, and Therapist Response | App Introduction to Intervention, High Dose, and App Response | App Introduction to Intervention, High Dose, and Therapist Response | Therapist Introduction to Intervention, High Dose, and App Response | App Introduction to Intervention, Standard Dose, and App Response | Therapist Introduction to Intervention, Standard Dose, and App Response |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 50.22 years STANDARD_DEVIATION 15.38 | 51.6 years STANDARD_DEVIATION 14.6 | 48.2 years STANDARD_DEVIATION 15.7 | 48.8 years STANDARD_DEVIATION 14.8 | 47.4 years STANDARD_DEVIATION 16.4 | 55.3 years STANDARD_DEVIATION 15 | 49.4 years STANDARD_DEVIATION 17.1 | 51.3 years STANDARD_DEVIATION 14.4 | 49.4 years STANDARD_DEVIATION 15.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 217 Participants | 29 Participants | 29 Participants | 27 Participants | 30 Participants | 26 Participants | 26 Participants | 24 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 4 Participants | 4 Participants | 3 Participants | 8 Participants | 5 Participants | 6 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 179 Participants | 24 Participants | 24 Participants | 25 Participants | 17 Participants | 21 Participants | 24 Participants | 21 Participants | 23 Participants |
| Region of Enrollment United States | 247 participants | 31 participants | 31 participants | 32 participants | 32 participants | 30 participants | 31 participants | 30 participants | 30 participants |
| Sex: Female, Male Female | 104 Participants | 11 Participants | 13 Participants | 15 Participants | 10 Participants | 12 Participants | 16 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Male | 143 Participants | 20 Participants | 18 Participants | 17 Participants | 22 Participants | 18 Participants | 15 Participants | 14 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 | 0 / 31 | 1 / 32 | 1 / 32 | 0 / 31 | 0 / 30 | 1 / 30 |
| other Total, other adverse events | 0 / 30 | 1 / 31 | 1 / 31 | 1 / 32 | 1 / 32 | 1 / 31 | 1 / 30 | 2 / 30 |
| serious Total, serious adverse events | 6 / 30 | 4 / 31 | 1 / 31 | 2 / 32 | 3 / 32 | 5 / 31 | 2 / 30 | 2 / 30 |
Outcome results
Primary
Patient Health Questionnaire-9 Item Scale (PHQ-9)
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
Time frame: 1 month post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 6.2 units on a scale | Standard Deviation 4.7 |
| Therapist Introduction to Intervention | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 6.4 units on a scale | Standard Deviation 4.8 |
| Standard Dose | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 7.0 units on a scale | Standard Deviation 5.2 |
| High Dose | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 5.6 units on a scale | Standard Deviation 4.2 |
| App Response | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 6.2 units on a scale | Standard Deviation 5.3 |
| Therapist Response | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 6.4 units on a scale | Standard Deviation 4.3 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-1.14, 1.2]
Comparison: Values are change in model-estimated means for his 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 \[-1\]).95% CI: [-2.39, -0.04]
Comparison: 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 \[-1\]).95% CI: [-1.12, 1.23]
Secondary
Change in EuroQOL Scale
A measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Time frame: Between baseline 3 months post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Change in EuroQOL Scale | 62.07 units on a scale | Standard Deviation 22.23 |
| Therapist Introduction to Intervention | Change in EuroQOL Scale | 65.47 units on a scale | Standard Deviation 24.44 |
| Standard Dose | Change in EuroQOL Scale | 61.68 units on a scale | Standard Deviation 24.15 |
| High Dose | Change in EuroQOL Scale | 66.21 units on a scale | Standard Deviation 22.48 |
| App Response | Change in EuroQOL Scale | 65.02 units on a scale | Standard Deviation 24.87 |
| Therapist Response | Change in EuroQOL Scale | 62.74 units on a scale | Standard Deviation 22.03 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-3.01, 9.37]
Comparison: 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 \[-1\]).95% CI: [-4.92, 7.47]
Comparison: 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 \[-1\]).95% CI: [-6.09, 6.3]
Secondary
Client Satisfaction Questionnaire (CSQ)
A measure of acceptability. Scores can range from 8 (worst) to 32 (best)
Time frame: 3 months post-randomization
Population: Data not collected.
Secondary
Client Satisfaction Questionnaire (CSQ)
A measure of acceptability. Scores can range from 8 (worst) to 32 (best)
Time frame: 1 month post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Client Satisfaction Questionnaire (CSQ) | 25.27 units on a scale | Standard Deviation 4.46 |
| Therapist Introduction to Intervention | Client Satisfaction Questionnaire (CSQ) | 25.31 units on a scale | Standard Deviation 4.82 |
| Standard Dose | Client Satisfaction Questionnaire (CSQ) | 24.86 units on a scale | Standard Deviation 5.11 |
| High Dose | Client Satisfaction Questionnaire (CSQ) | 25.71 units on a scale | Standard Deviation 4.1 |
| App Response | Client Satisfaction Questionnaire (CSQ) | 25.81 units on a scale | Standard Deviation 4.58 |
| Therapist Response | Client Satisfaction Questionnaire (CSQ) | 24.79 units on a scale | Standard Deviation 4.67 |
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)
Time frame: Between baseline 3 months post-randomization
Population: Data were not collected
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)
Time frame: At 1 month post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Distress Associated With Anxiety Symptom Frequency | 45.31 units on a scale | Standard Deviation 26.5 |
| Therapist Introduction to Intervention | Distress Associated With Anxiety Symptom Frequency | 49.54 units on a scale | Standard Deviation 25.04 |
| Standard Dose | Distress Associated With Anxiety Symptom Frequency | 50.11 units on a scale | Standard Deviation 26.07 |
| High Dose | Distress Associated With Anxiety Symptom Frequency | 44.67 units on a scale | Standard Deviation 25.38 |
| App Response | Distress Associated With Anxiety Symptom Frequency | 48.57 units on a scale | Standard Deviation 24.47 |
| Therapist Response | Distress Associated With Anxiety Symptom Frequency | 46.24 units on a scale | Standard Deviation 27.15 |
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)
Time frame: At 1 month post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Distress Associated With Depression Symptom Frequency | 41.22 units on a scale | Standard Deviation 28.53 |
| Therapist Introduction to Intervention | Distress Associated With Depression Symptom Frequency | 37.40 units on a scale | Standard Deviation 26.65 |
| Standard Dose | Distress Associated With Depression Symptom Frequency | 44.26 units on a scale | Standard Deviation 28.96 |
| High Dose | Distress Associated With Depression Symptom Frequency | 34.02 units on a scale | Standard Deviation 25.14 |
| App Response | Distress Associated With Depression Symptom Frequency | 41.34 units on a scale | Standard Deviation 28.36 |
| Therapist Response | Distress Associated With Depression Symptom Frequency | 37.25 units on a scale | Standard Deviation 26.78 |
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)
Time frame: Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED
Population: Data were not collected
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)
Time frame: At 3 months post-randomization
Population: Data were not collected
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)
Time frame: At 1 month post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Distress Associated With PTSD Symptom Frequency | 44.60 units on a scale | Standard Deviation 30.52 |
| Therapist Introduction to Intervention | Distress Associated With PTSD Symptom Frequency | 47.04 units on a scale | Standard Deviation 29.04 |
| Standard Dose | Distress Associated With PTSD Symptom Frequency | 49.56 units on a scale | Standard Deviation 28.59 |
| High Dose | Distress Associated With PTSD Symptom Frequency | 42.02 units on a scale | Standard Deviation 30.54 |
| App Response | Distress Associated With PTSD Symptom Frequency | 47.69 units on a scale | Standard Deviation 28.63 |
| Therapist Response | Distress Associated With PTSD Symptom Frequency | 43.94 units on a scale | Standard Deviation 30.84 |
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)
Time frame: Between baseline and 1 month post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | EuroQOL Scale | 61.56 units on a scale | Standard Deviation 23.07 |
| Therapist Introduction to Intervention | EuroQOL Scale | 63.60 units on a scale | Standard Deviation 21.25 |
| Standard Dose | EuroQOL Scale | 58.87 units on a scale | Standard Deviation 21.98 |
| High Dose | EuroQOL Scale | 66.56 units on a scale | Standard Deviation 21.64 |
| App Response | EuroQOL Scale | 63.91 units on a scale | Standard Deviation 21.43 |
| Therapist Response | EuroQOL Scale | 61.43 units on a scale | Standard Deviation 22.75 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-3.25, 7.91]
Comparison: 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 \[-1\]).95% CI: [-0.76, 10.4]
Comparison: 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 \[-1\]).95% CI: [-5.6, 5.56]
Secondary
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Time frame: Between baseline 3 months post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 5.62 units on a scale | Standard Deviation 5.07 |
| Therapist Introduction to Intervention | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 5.69 units on a scale | Standard Deviation 5.28 |
| Standard Dose | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 6.83 units on a scale | Standard Deviation 5.74 |
| High Dose | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 4.38 units on a scale | Standard Deviation 4.12 |
| App Response | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 6.25 units on a scale | Standard Deviation 5.45 |
| Therapist Response | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 5.11 units on a scale | Standard Deviation 4.86 |
95% CI: [-1.23, 0.91]
95% CI: [-2.29, -0.15]
95% CI: [-1.77, 0.37]
Secondary
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Time frame: Between baseline 1 month post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 5.5 units on a scale | Standard Deviation 5.4 |
| Therapist Introduction to Intervention | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 4.9 units on a scale | Standard Deviation 4.5 |
| Standard Dose | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 6.2 units on a scale | Standard Deviation 5.3 |
| High Dose | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 4.2 units on a scale | Standard Deviation 4.3 |
| App Response | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 5.1 units on a scale | Standard Deviation 4.7 |
| Therapist Response | Generalized Anxiety Disorder 7-item Scale (GAD-7) | 5.3 units on a scale | Standard Deviation 5.1 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-2.12, -0.16]
Comparison: 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 \[-1\]).95% CI: [-1.8, 1.49]
Comparison: 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 \[-1\]).95% CI: [-0.48, 1.49]
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
Time frame: 1 month post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| App Introduction to Intervention | Intervention Adherence: Activity in App During Final Week of Intervention | 105 Participants |
| Therapist Introduction to Intervention | Intervention Adherence: Activity in App During Final Week of Intervention | 108 Participants |
| Standard Dose | Intervention Adherence: Activity in App During Final Week of Intervention | 112 Participants |
| High Dose | Intervention Adherence: Activity in App During Final Week of Intervention | 104 Participants |
| App Response | Intervention Adherence: Activity in App During Final Week of Intervention | 105 Participants |
| Therapist Response | Intervention Adherence: Activity in App During Final Week of Intervention | 111 Participants |
Secondary
Intervention Adherence: Number of Views of Content
Quantified by mean (SD) number of intervention content (audio, video, text) views
Time frame: 1 month post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Intervention Adherence: Number of Views of Content | 34.24 mobile app content views | Standard Deviation 31.37 |
| Therapist Introduction to Intervention | Intervention Adherence: Number of Views of Content | 40.03 mobile app content views | Standard Deviation 35.82 |
| Standard Dose | Intervention Adherence: Number of Views of Content | 34.88 mobile app content views | Standard Deviation 35.81 |
| High Dose | Intervention Adherence: Number of Views of Content | 39.38 mobile app content views | Standard Deviation 31.38 |
| App Response | Intervention Adherence: Number of Views of Content | 40.53 mobile app content views | Standard Deviation 38.31 |
| Therapist Response | Intervention Adherence: Number of Views of Content | 33.70 mobile app content views | Standard Deviation 28.14 |
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).
Time frame: Between baseline 3 months post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Mindful Attention Awareness Scale (MAAS) | 22.43 units on a scale | Standard Deviation 5.51 |
| Therapist Introduction to Intervention | Mindful Attention Awareness Scale (MAAS) | 23.03 units on a scale | Standard Deviation 6.17 |
| Standard Dose | Mindful Attention Awareness Scale (MAAS) | 22.43 units on a scale | Standard Deviation 5.79 |
| High Dose | Mindful Attention Awareness Scale (MAAS) | 23.08 units on a scale | Standard Deviation 5.94 |
| App Response | Mindful Attention Awareness Scale (MAAS) | 22.57 units on a scale | Standard Deviation 6.23 |
| Therapist Response | Mindful Attention Awareness Scale (MAAS) | 22.90 units on a scale | Standard Deviation 5.51 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-0.45, 2.27]
Comparison: 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 \[-1\]).95% CI: [-1.33, 1.38]
Comparison: 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 \[-1\]).95% CI: [-1.72, 0.99]
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).
Time frame: Between baseline and 1 month post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Mindful Attention Awareness Scale (MAAS) | 23.41 units on a scale | Standard Deviation 5.22 |
| Therapist Introduction to Intervention | Mindful Attention Awareness Scale (MAAS) | 23.49 units on a scale | Standard Deviation 5.61 |
| Standard Dose | Mindful Attention Awareness Scale (MAAS) | 22.86 units on a scale | Standard Deviation 5.06 |
| High Dose | Mindful Attention Awareness Scale (MAAS) | 24.04 units on a scale | Standard Deviation 5.71 |
| App Response | Mindful Attention Awareness Scale (MAAS) | 23.31 units on a scale | Standard Deviation 5.67 |
| Therapist Response | Mindful Attention Awareness Scale (MAAS) | 23.59 units on a scale | Standard Deviation 5.18 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-0.62, 1.78]
Comparison: 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 \[-1\]).95% CI: [-0.47, 1.92]
Comparison: 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 \[-1\]).95% CI: [-1, 1.39]
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).
Time frame: Between baseline 3 months post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Patient Health Questionnaire 10-item Scale (PHQ-10) | 6.21 units on a scale | Standard Deviation 3.44 |
| Therapist Introduction to Intervention | Patient Health Questionnaire 10-item Scale (PHQ-10) | 5.63 units on a scale | Standard Deviation 3.72 |
| Standard Dose | Patient Health Questionnaire 10-item Scale (PHQ-10) | 6.15 units on a scale | Standard Deviation 3.86 |
| High Dose | Patient Health Questionnaire 10-item Scale (PHQ-10) | 5.64 units on a scale | Standard Deviation 3.28 |
| App Response | Patient Health Questionnaire 10-item Scale (PHQ-10) | 5.85 units on a scale | Standard Deviation 3.58 |
| Therapist Response | Patient Health Questionnaire 10-item Scale (PHQ-10) | 5.96 units on a scale | Standard Deviation 3.62 |
95% CI: [-1.41, 0.41]
95% CI: [-1.27, 0.55]
Comparison: 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 \[-1\]).95% CI: [-0.4, 1.42]
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).
Time frame: Between baseline and 1 month post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Patient Health Questionnaire 10-item Scale (PHQ-10) | 6.50 units on a scale | Standard Deviation 3.16 |
| Therapist Introduction to Intervention | Patient Health Questionnaire 10-item Scale (PHQ-10) | 6.19 units on a scale | Standard Deviation 3.45 |
| Standard Dose | Patient Health Questionnaire 10-item Scale (PHQ-10) | 6.66 units on a scale | Standard Deviation 3.44 |
| High Dose | Patient Health Questionnaire 10-item Scale (PHQ-10) | 6.02 units on a scale | Standard Deviation 3.16 |
| App Response | Patient Health Questionnaire 10-item Scale (PHQ-10) | 6.31 units on a scale | Standard Deviation 3.32 |
| Therapist Response | Patient Health Questionnaire 10-item Scale (PHQ-10) | 6.37 units on a scale | Standard Deviation 3.32 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-1.3, 0.3]
Comparison: 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 \[-1\]).95% CI: [-1.33, 0.27]
Comparison: 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 \[-1\]).95% CI: [-0.55, 1.05]
Secondary
Patient Health Questionnaire-9 Item Scale (PHQ-9)
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
Time frame: Between baseline 3 months post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 7.28 units on a scale | Standard Deviation 5.76 |
| Therapist Introduction to Intervention | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 7.04 units on a scale | Standard Deviation 5.5 |
| Standard Dose | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 8.12 units on a scale | Standard Deviation 6.23 |
| High Dose | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 6.10 units on a scale | Standard Deviation 4.65 |
| App Response | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 6.73 units on a scale | Standard Deviation 5.69 |
| Therapist Response | Patient Health Questionnaire-9 Item Scale (PHQ-9) | 7.55 units on a scale | Standard Deviation 5.53 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-1.66, 1.01]
Comparison: 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 \[-1\]).95% CI: [-2.81, -0.14]
Comparison: 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 \[-1\]).95% CI: [-0.52, 2.15]
Secondary
Post-Traumatic Stress Symptom Inventory (PTSS)
Absolute values, not change scores. PTSD symptoms. Scores can range from 10 (best) to 70 (worst).
Time frame: Between baseline 3 months post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Post-Traumatic Stress Symptom Inventory (PTSS) | 29.94 units on a scale | Standard Deviation 23.88 |
| Therapist Introduction to Intervention | Post-Traumatic Stress Symptom Inventory (PTSS) | 27.83 units on a scale | Standard Deviation 15.1 |
| Standard Dose | Post-Traumatic Stress Symptom Inventory (PTSS) | 31.75 units on a scale | Standard Deviation 24.05 |
| High Dose | Post-Traumatic Stress Symptom Inventory (PTSS) | 25.67 units on a scale | Standard Deviation 13.05 |
| App Response | Post-Traumatic Stress Symptom Inventory (PTSS) | 29.75 units on a scale | Standard Deviation 23.95 |
| Therapist Response | Post-Traumatic Stress Symptom Inventory (PTSS) | 27.99 units on a scale | Standard Deviation 14.89 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-4.41, 1.25]
Comparison: 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 \[-1\]).95% CI: [-3.26, 2.42]
Comparison: 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 \[-1\]).95% CI: [-1.35, 4.33]
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).
Time frame: Between baseline and 1 month post-randomization
Population: Participants who had data collected at both time points.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| App Introduction to Intervention | Post-Traumatic Stress Symptom Inventory (PTSS) | 28.91 units on a scale | Standard Deviation 28.14 |
| Therapist Introduction to Intervention | Post-Traumatic Stress Symptom Inventory (PTSS) | 26.38 units on a scale | Standard Deviation 13.08 |
| Standard Dose | Post-Traumatic Stress Symptom Inventory (PTSS) | 31.53 units on a scale | Standard Deviation 28.04 |
| High Dose | Post-Traumatic Stress Symptom Inventory (PTSS) | 23.65 units on a scale | Standard Deviation 11.04 |
| App Response | Post-Traumatic Stress Symptom Inventory (PTSS) | 29.53 units on a scale | Standard Deviation 27.81 |
| Therapist Response | Post-Traumatic Stress Symptom Inventory (PTSS) | 25.77 units on a scale | Standard Deviation 13.36 |
Comparison: Values are change in model-estimated means for therapist vs. app introduction. 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 \[-1\]).95% CI: [-5.26, -0.13]
Comparison: 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 \[-1\]).95% CI: [-4.46, 0.67]
Comparison: 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 \[-1\]).95% CI: [-3.31, 1.83]
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)
Time frame: 3 months post-randomization
Population: Data not collected.
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)
Time frame: 1 month post-randomization
Population: Data not collected.