A Pilot, Feasibility Randomized Controlled Trial of a Behavioral Activation And Rehabilitation Intervention To Improve Psychological And Physical Impairments In Acute Respiratory Failure Survivors
Phase: NA
Conditions: Respiratory Insufficiency, Depression, Rehabilitation, Critical Care
Sponsor: Johns Hopkins University

Behavioral Activation-Rehabilitation to Improve Depressive 
Symptoms & Physical Function After Acute Respiratory 
Failure
NCT03431493
9/5/2020

 
 
 
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Date: 9/5/2020 
Principal Investigator: Ann M. Parker, MD 
Application Number: IRB00143231 
 
 
 
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1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
A growing number of Acute Respiratory Failure (ARF) survivors are burdened by depressive 
symptoms and physical impairments that last for years after intensive care unit discharge. 
Notably, depressive symptoms are independently associated with subsequent development of 
new impairments in physical functioning. There are no randomized controlled trials (RCT), in 
ARF survivors, evaluating any intervention for depression. To improve mental and physical 
health outcomes in ARF survivors, the following gaps within existing patient-oriented research 
must be addressed: 1) interventions to improve depressive symptoms and associated physical 
functioning impairments, 2) evaluation of modifiable psychosocial risk factors for depressive 
symptoms, and 3) validation of screening instruments to assess depressive symptoms. This K23 
application, by Ann Parker, MD, aims to address these gaps by designing and conducting a 
pilot RCT (Aim 1) of an intervention combining Behavioral Activation and physical 
rehabilitation (delivered via telephone and 2 home visits over 12-weeks) versus a “usual care” 
control group, and evaluating its feasibility (primary outcome) and efficacy to reduce 
depressive symptoms and improve physical functioning (secondary outcomes). Behavioral 
Activation, as proposed for this pilot RCT, is an evidence-based psychological treatment for 
depression, which increases adaptive behaviors to achieve patient-valued goals. This project 
will evaluate the feasibility and efficacy of the BA-R intervention both quantitatively and 
qualitatively, through semi-structured interviews. Using the combined patient cohort from the 
intervention and control groups of the RCT, Dr. Parker also will evaluate modifiable 
psychosocial risk factors for depressive symptoms in ARF survivors and the association 
between the intervention and these modifiable factors (Aim 2), and the measurement properties 
of two commonly used depression screening instruments in ARF survivors versus a “gold 
standard” clinician diagnostic interview that she will be trained to perform (Aim 3).   
 
 
 
 
 
 
 
 

 
 
 
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2. 
Objectives (include all primary and secondary objectives) 
 
Aim 1: To conduct a single-site, pilot RCT (N=54) evaluating the feasibility (primary objective) and 
efficacy (secondary objective) of a 12-week behavioral activation-rehabilitation (BA-R) intervention versus 
“usual care”, in acute respiratory failure (ARF) survivors. 
Hypothesis 1a: A 12-week BA-R intervention in ARF survivors will be feasible, as demonstrated  
by an average accrual rate of 1.5 patients per month, completion of >80% of the 12-week phone calls, and 
<15% of enrolled patients lost to follow-up at the end of the 12-week intervention. 
Hypothesis 1b: At the end of the 12-week BA-R intervention, ARF survivors in the BA-R versus “usual 
care” group will demonstrate decreased depressive symptoms, less impairments in physical function and 
quality of life, and reduced healthcare utilization 
Hypothesis 1c: We will conduct qualitative research, using thematic analysis, to identify key barriers and 
facilitators to engaging with the BA-R intervention, as well as perceived satisfaction, acceptability and 
feasibility of BA-R. 
 
Aim 2: To evaluate the association between resilience, coping and social engagement with depressive 
symptoms and the association between these factors and the BA-R intervention among at-risk ARF 
survivors from Aim 1. 
Hypothesis 2a: Increased resilience, adaptive coping, and social engagement are associated with fewer 
depressive symptoms using the combined patient cohort from the BA-R and control groups in Aim 1 
Hypothesis 2b: At the end of the 12-week intervention, ARF survivors in the BA-R versus “usual care” 
control group will demonstrate improvements in coping, resilience and social engagement. 
Hypothesis 2c: We will conduct qualitative research, using thematic analysis, to identify the role of 
resilience, coping, and social engagement in recovery from ARF. 
 
Aim 3: To evaluate measurement properties (e.g., sensitivity, specificity, positive/negative predictive 
values) of two commonly-used depression screening instruments (i.e., Hospital Anxiety and Depression 
Scale (HADS) and Personal Health Questionnaire Depression Scale-8 (PHQ-8)) for detecting depressive 
symptom severity using a “gold standard” depression measure (i.e., Structured Clinical Interview for the 
Diagnostic and Statistical Manual of Mental Disorders 5th Edition (SCID-5)), in at-risk ARF survivors from 
Aim 1. 
Hypothesis 3: The HADS and PHQ-8 will adequately discriminate depressive symptom severity compared 
to the SCID-5 “gold standard” using the combined patient cohort from the BA-R and control groups in  
Aim 1. 
 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
BACKGROUND AND SIGNIFICANCE: Annually, >750,000 Americans have acute respiratory failure 
(ARF) requiring mechanical ventilation.1-3 As the population ages, the incidence of ARF is increasing, with 
a projected 80% rise by 2026.4,5 At the same time, due to medical advances, ARF survival is improving,6 
leading to a growing number of survivors who frequently experience significant psychological sequelae 
(e.g., depression)7 and physical morbidities (e.g., impairments in physical functioning).8-12 After ARF, the 
cumulative incidences, over 2 years, of new depressive symptoms and impairment physical functioning are 
40% and 66%, respectively.10 Psychological and physical impairments may synergistically yield worse 
outcomes,13 with ARF research, conducted by my mentors, showing depressive symptoms are an 
independent risk factor for new onset of impaired physical functioning.10 
 
As part of the scientific premise for this proposal, prior work, conducted by co-mentor, Mark Hegel, 
PhD, showed that only treating depression in other medically ill populations with functional impairments is 
NOT sufficient to achieve optimal improvement in patient outcomes. With depressed, medically ill older 

 
 
 
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adult outpatients, there were improvements in emotional outcomes, without improvements in physical 
functioning.14 In a depression prevention study in older adults with low vision, depression incidence was 
halved at 2-month follow up, but the benefit was not maintained at 6 months.15 However, a depression 
prevention study that included BOTH a depression treatment (Behavioral Activation (BA)) and an 
occupational therapist (OT) rehabilitation intervention again halved the incidence of depression that was 
then sustained for 4 months AND improved physical function.16 These findings support including physical 
rehabilitation with psychological interventions for at-risk chronically ill populations. 
 
In ARF survivors, in addition to a paucity of efficacious interventions to address impairments in 
physical function and depressive symptoms, gaps remain in the existing literature regarding understanding 
and measuring depressive symptoms. First, while prior studies have identified risk factors for depressive 
symptoms in ARF survivors,7 few have evaluated important psychosocial factors, such as social 
engagament,17-20 resilience21-24 and coping,18,25-29 that may be important in designing interventions. 
Moreover, a “gold standard” depression diagnostic outcome measure is not feasible for large studies,7,30 
and no existing depression screening instruments have been evaluated against a “gold standard” clinician 
diagnostic interview in ARF survivors.31 
          The urgent need to identify modifiable risk factors for depressive symptoms and develop new 
strategies that address the multi-faceted nature of impairments after ARF has been recognized by the 
American Thoracic Society and Society of Critical Care Medicine.13,32 Further, as per the NHLBI’s new 
Strategic Vision, there is a need to develop interventions, within a multidisciplinary framework, to facilitate 
behavioral modification for disease treatment and incorporate such interventions into community-level 
patient care.33  
 
SCIENTIFIC PREMISE:  Gaps in Existing Literature on Risk Factors for Depressive Symptoms in ARF 
Survivors: Resilience,34,35 coping style36 and social support and engagement37,38 are inter-related 
psychosocial factors associated with depressive symptoms in other populations, but have been evaluated in 
only 2 studies in ARF survivors.7,39,40 Moreover, resilience and coping are important in mediating the 
positive effects of depression interventions in other populations,41-43 but have had little study in ARF 
survivors. Moreover, engaging social support networks may enhance interventions to address depressive 
symptoms.44 Hence, there are major gaps in existing literature for these factors. 
 
No Validation of Depression Screening Instruments against a “Gold Standard” in ARF Survivors: A recent 
Scoping Review of outcome measures in ARF research reported the Hospital Anxiety and Depression Scale 
(HADS)45 was the most common depression instrument (60% of ARF studies).30 The Personal Health 
Questionnaire-9 (PHQ-9), likewise, is widely used both clinically and in research studies.46 The PHQ-8 and 
PHQ-9 are highly correlated,47 differing only in omission of 1 question regarding self-harm, and for 
medicolegal reasons, the PHQ-8 is often preferred for research.48,49 While both the HADS and PHQ-8 are 
valid and reliable in other populations, their measurement properties have never been evaluated against a 
“gold standard” clinician diagnostic interview in ARF survivors. Importantly, ARF patients may differ 
from other populations in etiology and manifestations of depressive symptoms given the potential 
contribution of co-morbidities50 and the physiologic stress of critical illness (e.g., prolonged inflammatory 
state).7 Indeed, our systematic review demonstrated that traditional risk factors for depressive symptoms in 
the general population (e.g. sex) did not apply to ARF survivors, suggesting that other factors, such as 
neuro-inflammation, might play a larger role in these patients.7 These issues make validation51 of 
depressive screening instruments in this unique ARF survivor population essential to the validity of future 
research in the field.  
 
Strengths and weaknesses of Existing Research in ARF Survivors: Compared to the large number of studies 
describing impairments in ARF survivors, a systematic review reported that the number of interventional 
studies is modest, and interventions with proven effects are “rare.”52,53 Recent systematic reviews 
demonstrate there are no existing trials specifically evaluating evidence-based depression interventions and 
only one54 evaluating a combined psychological/physical intervention in ARF.7,52,53,55,56  

 
 
 
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Three randomized trials in ARF survivors offer insights. First, an 8-week, home-based exercise 
intervention with home visits and phone calls from a physical therapist (PT) versus usual care in 195 ARF 
survivors discharged to home found no significant effect on physical function, measured via 6-minute walk 
test (mean outcome: ~400 meters) and SF-36 survey (mean outcome: ~1.5 SD below norm) at the end of 
treatment (8 weeks), with little change at 26 weeks.57 The investigators hypothesized poor adherence to the 
exercise intervention influenced this null finding. Second, an exercise intervention in 150 ARF patients 
randomized to rehabilitation in-ICU and continued for 8 weeks as outpatient versus usual care showed no 
significant effects on 6-minute walk test (primary outcome) or quality of life at discharge, 3, 6, or 12 month 
follow-up.58 Adherence with the outpatient rehabilitation intervention was poor (41%) and investigators 
hypothesized that (1) a home-based (vs. clinic-based) intervention may be superior to improve adherence 
and (2) failure to address psychological problems contributed to null results. Finally, the authors suggested 
that future studies use outcome measures focused on participation restrictions in the home (e.g. patient-
reported physical function), which may demonstrate treatment effects beyond standardized performance-
based physical measures (e.g., 6-minute walk test). Third, a United Kingdom (UK) trial,54 which 
randomized patients to a rehabilitation manual vs usual care, demonstrated better quality of life scores (via 
SF-36 survey) at the end of the 6-week intervention. However, there was no difference in depressive 
symptoms between the two groups. Given vastly lower access to outpatient physical rehabilitation, as part 
of “usual care” in the UK vs. USA, these results are not generalizable to the USA setting. 
 
Lack of Clinical Trials Demonstrating Effective Interventions to Improve Depressive Symptoms in ARF: In 
a systematic review by our group, there was a paucity of clinical trials evaluating an intervention 
specifically to reduce depressive symptoms in ARF survivors,7  and there was preliminary evidence 
supporting post-ICU outpatient physical rehabilitation interventions to improve depressive symptoms in 
ARF survivors.  
 
Behavioral Activation is Effective & Accessible Treatment for Depression: For depression, behavioral 
activation (BA) is the primary behavioral treatment within the class of evidence-based psychotherapies 
known as Cognitive Behavioral Therapy.59,60 BA theory holds that inadequate environmental reinforcement 
(i.e., behaviors leading to positive or desired outcomes) and/or too much environmental punishment (i.e., 
behaviors leading to aversive or undesired outcomes), can contribute to depression via extinction of 
adaptive behaviors and avoidance of taking action.60,61 BA addresses these issues by “activating” depressed 
persons to re-engage with their environments. BA interventions for depression have shown large effect 
sizes (e.g., 0.87).62 BA is superior to cognitive therapy (the most widely studied psychotherapy for 
depression) with comparable effect to antidepressant medication, even for severely depressed patients.63 
Moreover, these positive effects of BA were retained 2 years later and comparable to continued medication 
treatment.64 Finally, BA is time-efficient, not requiring advanced skills or complex training, making BA 
suitable for wide-scale dissemination.62  For additional SCIENTIFIC PREMISE, see Section 3.1  
 
Summary of Significance: Given the increasing number of ARF survivors, and associated public health 
burden due to long-lasting mental and physical impairments, research evaluating modifiable psychosocial 
risk factors and establishing validated screening instruments for future research is a priority as per the 
American Thoracic Society, Society of Critical Care Medicine and NHLBI’s strategic vision. Moreover, 
designing effective interventions to address co-existing, long-lasting psychological and physical 
impairments is essential to enhancing recovery in ARF survivors as per existing literature. Existing studies 
are limited, focused primarily on physical interventions, and not demonstrating efficacy. Improving 
existing interventions by addressing depressive symptoms, physical functioning AND adaptation to ARF 
survivorship is a key component missing in prior studies; the proposed BA-R intervention addresses this 
gap. 
 
PRELIMINARY DATA: Depressive Symptoms and Physical Impairments are Very Common in ARF: Our 
research team has conducted seminal studies on the psychological and physical impairments of ARF 

 
 
 
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survivors. These papers, several of which were authored by Dr. Parker, include systematic and narrative 
reviews regarding post-ARF depression,7,56,65 PTSD,65-67 anxiety,65,68 neuromuscular abnormalities,69-71 and 
physical impairments.72-75 Importantly, our recent systematic and scoping reviews found limited prior 
research in ARF survivors regarding: 1) modifiable risk factors (e.g. resilience, coping) for depressive 
symptoms,7 2) consensus regarding depression screening instruments,30 and 3) comparison of any 
depression screening instrument against a “gold standard” diagnostic interview.31 Our research 
demonstrated high prevalences of depressive symptoms and physical impairments after ARF (40% and 
66%, respectively), and depressive symptoms are independently associated with new impairments in 
physical functioning (OR=2.7, P=0.02).10  
 
Behavioral Intervention Research in Medical Populations: Mark Hegel, PhD (co-mentor) previously 
designed a psychological intervention similar to the proposed BA intervention, called Problem Solving 
Therapy (PST), administered by nurses in primary care,76 for the largest geriatric depression treatment trial 
(N=1801): Project IMPACT.77 Participants receiving PST (vs. a community-based therapy control) showed 
significantly improved depressive symptoms at 12 months post-intervention.78 Thereafter, his group 
conducted RCTs to evaluate PST to prevent depression in older adults after stroke79 and with macular 
degeneration.15,16 PST was superior to usual care controls, and equivalent to antidepressant medication. 
More recently, Dr. Hegel evaluated delivery of PST via Skype (Tele-PST) to homebound elders with 
depression, showing that Tele-PST was highly acceptable.80-82 This evidence shows that this intervention, 
that is closely related to BA, is effective in adults with medical co-morbidities and functional impairment, 
when administered in-person, by phone or by Skype. These studies demonstrate our group’s proficiency 
with conducting RCTs of psychosocial, phone-assisted interventions. Drs. Hegel and Lyons (co-mentors) 
also conducted research integrating Behavioral Activation with PST and occupational therapy (OT) 
interventions (BA-Rehabilitation or BA-R) for cancer survivors83-86 and for older adults with macular 
degeneration.16 The following theories provide the foundation for the prior research: (1) OT, which 
emphasizes participation in daily activities, is synergistic with BA and PST, (2) having BA provided by OT 
and other non-mental health providers expands its accessibility (BA requires less psychotherapeutic 
expertise than PST), and (3) the unique treatment focus of OT may extend the effectiveness of BA for 
improving both psychological and physical functioning.  
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures (distinguish research 
procedures from those that are part of routine care). 
 
Overview of Research Methods for Aims 1, 2, & 3 
A single cohort of patients will be used for all 3 Aims (i.e. both intervention and control groups recruited 
into the randomized controlled trial (RCT) will form a single cohort for analyses in Aims 2 and 3). We will 
enroll 54 patients from all Johns Hopkins Hospital adult ICUs. If patients are lost to follow-up, we will 
enroll up to 10 additional patients to obtain 12-week outcomes assessments on a total of 54 patients (27 in 
each group). Oral informed consent will be obtained from all participants.  
 
Aim 1 Methods: We will conduct a single-site, pilot RCT (N=54) evaluating the feasibility (primary 
objective) and efficacy (secondary objective) of a 12-week behavioral activation-rehabilitation (BA-R) 
intervention versus “usual care”, in acute respiratory failure (ARF) survivors. We will evaluate the BA-R 
intervention via an RCT study design, with blinded outcome assessments. We will test the feasibility of this 
intervention (primary outcome) and its efficacy (secondary outcome) at the end of intervention. Figure 2 
shows study timeline.  
 
After return home, consented patients will be randomized to: (1) behavioral activation and rehabilitation 
(BA-R) intervention or usual care. Randomization will occur via web-based tool, using variable-sized 

 
 
 
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blocks from 2 to 4, and stratified by history of depression prior to ICU admission (based on chart review 
and patient interview). Baseline variables are detailed in Table 1 below. 
Table 1:  Baseline Variables 
Variable 
Collection 
Measurement Scale 
Patient Variables 
Age/sex/race 
Chart review 
Continuous/Binary/Categorical 
Education (number of years/highest attainment) 
Patient interview 
Continuous/Categorical 
Employment & Health Insurance status 
Patient interview 
Categorical 
Comorbidity indices: Charlson (CCI)a & Functional (FCI)b 
Chart review 
Ordinal 
Alcohol intake/misuse / Drug abuse 
chart review 
Categorical 
Physical function at baseline: AMPAC-CAT87,88 c 
Patient interview 
Continuous 
ICU and Hospital Variables 
ICU admission diagnosis (e.g., sepsis, renal failure)  
Chart review 
Categorical 
Severity of illness: APACHE IId 
Chart review 
Continuous 
Benzodiazepine use and dosing56,89,90  
Chart review 
Continuous 
Daily ICU Sedation Status: RASS91 
Chart review 
Ordinal 
Daily ICU Delirium Status: CAM-ICU92,93 
Chart review 
Categorical 
Daily Minimum Glucose90  
Chart review 
Continuous 
ICU and Hospital Length of Stay 
Chart review 
Continuous 
Before start of intervention, once participant at homec 
Depressive Symptoms: HADS45 
Patient interview 
Continuous 
Coping Style & Social Engagement: Brief Cope94  & BADS95  
Patient interview 
Continuous 
Resilience: CD RISC96 
Patient interview 
Continuous 
Abbreviations: AMPAC-CAT = Activity Measure for Post-Acute Care- Computer Adaptive Test, RASS = Richmond Agitation Sedation Scale, CAM-ICU = Confusion 
Assessment Method for the ICU, HADS= Hospital Anxiety and Depression Scale, PHQ= Personal Health Questionnaire, SCID-5= Structured Clinical Interview for DSM-5 
(Mood Disorders Section only), BADS= Behavioral Activation for Depression Scale, CD RISC= Connor Davidson Resilience Scale, SF-36= 36 item Short Form Survey 
a:Charlson index: a score derived from 19 comorbidities, with an increased score reflecting increased 1-year mortality97 
b:Functional Index: derived from 18 comorbidities using physical function as outcome; increased score predicts decreased function98  
c: See Section 3.3.8 for description of instruments 
d: APACHE II: severity score that accounts for age, medical conditions, and 12 acute physiologic variables in ICU99  
 
 
 
 
 
Physical and Occupational Therapy Initial Home Visits: Within about 2 weeks of arriving home, 
participants will receive an audiovisualvisit from a physical therapist (PT) and occupational therapist (OT). 
The PT will (1) assess home safety, (2) recommend environmental modifications (e.g., grab bars) and (3) 
when indicated, use standardized, validated and feasible tests for ICU survivors to assess strength (via 
manual muscle testing)9,73 and mobility (via 4 meter timed walk).100 Given current restrictions (as of March 

 
 
 
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13, 2020) due to the coronavirus pandemic, home visits have been converted to audiovisual visits. The PT 
will provide resources to obtain low cost equipment (e.g., walkers), if required. In both groups, acute need 
for PT/OT services will be as per standard of care (i.e., physician referral); study participation (in either 
randomized group) will not impact standard care. The OT will then assist the patient in identifying valued 
activities (i.e., activities performed for their intrinsic worth) in the participant’s life. The OT will guide and 
facilitate developing goals for completing valued activities, based on ratings of importance and satisfaction 
with performance on the COPM and performed in the participant’s home, by the end of the first week. The 
OT will then evaluate the participant's ability to perform the prioritized activities. The OT will work with 
the participant to set BA goals for these selected activities, by embedding physical exercise (as 
recommended by PT) into valued daily routines. Goals will be divided into step-by-step plans, which 
incorporate appropriate expectations for participant activity during recovery. If the necessary steps to 
achieve these goals are not readily apparent to the participant, the OT will implement standard problem-
solving strategies.16,83,85 The visit will end with the OT entering the identified goals for the valued activities 
into the participant’s Progress Worksheet (see below). 
 
BA-R Phone intervention: WEEKS 1-6: Approximately one week after the OT home visit, and weekly 
thereafter throughout the initial 6-week intervention period, the participant will receive a phone call from 
the OT. During each call, the OT will query participants’ success with BA-R goals and adherence barriers 
(e.g., need for assistance, lack of motivation). If goals are met, the OT will help the participant establish 
goals for the next week, and these goals along with an action plan will be delineated in a Progress 
Worksheet. If the goals are not met, the OT will assist the participant in addressing barriers as detailed 
above. WEEKS 7-12: At about 6 weeks, the PT will conduct a second audiovisual visit. Given current 
restrictions (as of March 13, 2020) due to the coronavirus pandemic, home visits have been converted to 
audiovisual visits. The PT will assess if the exercise level should be changed (e.g., increase or decrease 
intensity/duration). The OT will review progress on the action plan. Depending on achievement, participant 
preferences, and recovery trajectory, the OT and participant will develop new goals for participating in 
valued activities over the next 2 weeks. An action plan to achieve these goals will be entered into the 
Progress Worksheet. Phone calls will continue every 2 weeks during weeks 8-12. This will allow the OT to 
determine whether the participant has mastered the concept of goal setting and can stay on track with less 
contact.  
 
Usual Care Control Group:  Participants randomized to this arm will receive usual care only, in order to 
reflect a real-world comparator. This group is expected to include primary care, possibly outpatient 
physical therapy, mental health, and home health nurses. As per Table 2, these data will be collected to 
describe usual care received by the control group. These same data also will be collected for the 
intervention group to characterize usual care received outside of the BA-R intervention. These data will be 
recorded from the time of enrollment until end of the intervention. 
Table 2: Mental Health & Physical Rehabilitation “Usual Care” Data Collection (both Intervention & Control Group)  
Mental Health Care 
1.  Psychiatric pharmacotherapy (e.g., anti-depressant, anti-anxiety meds) 
a. Including drug name, dose, frequency & duration of use 
2. Provider Visits* (including psychotherapy, counselling and support) 
a. Number, frequency & duration  
b. Type,** frequency & duration of intervention 
Physical Rehabilitation Care 
1.  Provider Visits: Physical therapist, Occupational therapist, Physiatry/Rehabilitation Physician  
a. Number, frequency & duration 
b. Location (clinic vs. home-based) 
* categories for Psychiatrist, Psychologist, Social Worker, Counselor, Support Group, and Primary Care Physician (if mental health services provided) 
** including goal setting, homework, problem solving, family meetings, discussion of personal relationships, group interactions and relaxation techniques 
 
Methods for Aims 1c & 2c: Using thematic analysis, semi-structured telephone interviews will be 
conducted by Dr. Parker and a trained research assistant using a written interview guide. The guide will be 

 
 
 
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developed by Dr. Parker with input from Drs. Eakin and Needham (co-mentor & primary mentor, 
respectively) and the questions will be iteratively refined throughout the study period in order to optimize 
information gained about themes as they arise. The interviews will begin with open-ended questions about 
patient experiences in recovery after ARF. Broad questions will then be followed by more specific 
questions about: 1) resilience, coping and social engagement; 2) key barriers and facilitators to engaging 
with the BA-R intervention; and 3) perceived satisfaction, acceptability and feasibility of BA-R. The 
anticipated duration is 25-30 minutes per interview.  
 
Methods for Aim 3: The 3 instruments required for Aim 3 are described in Table 4 and under Secondary 
Outcomes below – all instruments are measured at the end of the 12-week intervention. The SCID-5 will be 
administered by Dr. Parker blinded to results of HADS and PHQ-8. The HADS and PHQ-8 will be 
administered by a research assistant blinded to the SCID-5. 
  
b. Study duration and number of study visits required of research participants. 
 
As described above, the intervention will start within approximately 2 weeks of hospital discharge and last 
about 12 weeks. After the 12 week intervention period, all participants will be contacted for outcomes 
assessments via telephone. This will take place as soon as possible after the end of the intervention. They 
will also be contacted by phone weekly for weeks 2-5 and then every other week for weeks 8-12.  
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Participants cannot be blinded to the intervention. Treatment allocation will be concealed, except to staff 
performing the intervention. Research staff performing all outcome assessments will be blinded (except Dr. 
Parker who will not be masked to treatment assignment and will administer the SCID). Patients will be 
instructed (using standard language, as per prior research)101-103 not to discuss treatment allocation with 
staff prior to each assessment. Adequacy of blinding will be assessed by asking assessors to indicate if they 
were un-blinded and for their “best guess” of patients’ treatment allocation.103 
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
 
All study participants in the usual care group will receive routine care. Participants in the intervention 
group will receive the intervention in addition to routine care. 
 
e. Justification for inclusion of a placebo or non-treatment group. 
 
We chose to compare our intervention against a “usual care”, rather than a sham control that would attempt 
to control for extra attention but does not represent real-world usual care. We will measure usual care for 
both control and intervention groups (Table 2). Participants in the usual care group will not be deprived of 
any known potential benefits by not being included in the intervention group (no proven benefit yet in the 
ARF population). 
 
f. Definition of treatment failure or participant removal criteria. 
 
Participants will only be removed from the study if they withdraw consent. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 

 
 
 
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If a participation in the study ends prematurely, the participant will continue to receive usual care. Ending 
the intervention prematurely does not pose any harm to the participant. 
 
5. 
Inclusion/Exclusion Criteria 
 
 
6. 
Drugs/ Substances/ Devices 
 
N/A 
 
7. 
Study Statistics 
a. Primary outcome variable. 
 
The primary outcome variable is feasibility. We will assess the total number of intervention phone calls 
completed per patient as a proportion of the number of intervention phone calls each patient is intended to 
complete (i.e., 9 intervention calls – weekly during first 6 weeks and bi-weekly for second 6 weeks of the 
12-week protocol). We also will assess total number of intervention phone calls completed by all study 
participants as a proportion of total intervention phone calls expected in the study (i.e., 9 calls/patient x 27 
intervention patients = 243 calls). We will calculate the number of patients completing the 12-week follow-
up session as a proportion of the number of patients enrolled to measure of loss to follow-up. 
 
b. Secondary outcome variables. 
 
Hospital Anxiety and Depression Scale (HADS)45: The HADS (Tables 1 and 4), separately assesses 
depressive and anxiety symptoms in a wide variety of patients, is valid, reliable45,56,65,105,106 and highly 
correlated with psychiatric evaluation in other populations,107 but never validated in ARF survivors. A 
HADS score ≥8 indicates clinically important depressive symptoms. Scores of 8-10 indicates “mild” 
symptoms, 11-14 “moderate”, and ≥15 “severe”. HADS is the most commonly used measure of depressive 
symptoms in ARF survivors10,56,108 and is considered to be particularly appropriate in ARF patients because 
 
Table 3. Eligibility Criteria 
Inclusion Criteria: 
≥18 years old 
Living at home before the current admission (not in a facility) 
Acute respiratory failure  managed in the ICU ≥ 24hrs  (≥1 of the following): 
1) 
Mechanical ventilation via an endotracheal tube or tracheostomy > 12hrs (and not ventilator-dependent before admission) OR 
2) 
Non-invasive ventilation (CPAP, BiPAP) > 4 hours in a 24 hour period provided for acute respiratory failure (not for OSA or other 
stable use) OR 
3) 
High flow nasal cannula with FiO2 ≥ 0.5 for ≥4 hours in a 24hr period 
At least mild depressive symptoms (score ≥2 on PHQ-2 scale46)  
Exclusion Criteria: 
Pre-existing cognitive impairment (based on review of medical records, or proxy-administered IQ-CODE104 score >3.3)  
Declines informed consent or not capable of providing informed consent  
Non-English speaking 
Homelessness  
Bedbound prior to the current admission 
Expected survival < 6 months according to ICU attending 
ICU LOS > 30 days 
Not discharged home from the hospital 
Complex medical care expected soon after discharge (e.g. multiple planned surgeries, transplantation evaluation, extensive travel needs for 
hemodialysis, chemotherapy or radiation therapy, etc) 
Active substance abuse or psychosis   
Pregnancy 
Suicidality 
Incarcerated 
Lack of access to telephone or inability to use telephone independently 
Pregnancy 
Suicidality 

 
 
 
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HADS does not emphasize the physical symptoms of depression that may be confounded by post-ARF 
physical morbidity.  
Personal Health Questionnaire (PHQ-8)46: The PHQ-8 uses a 4-point Likert scale to assess depressive 
symptoms (Scores 5-9 indicate “mild” symptoms, 10-14 “moderate”, and ≥20 “severe” depressive 
symptoms). While PHQ-9 has been validated for diagnostic accuracy in many other populations, it has not 
been evaluated against a “gold standard” clinician diagnostic interview in ARF survivors. As commonly 
done for medicolegal reasons in research, the PHQ-8, rather than PHQ-9, is used since it removes a 
question regarding suicidal ideation.48 
Structured Clinical Interview for the DSM-5 (SCID-5) – Mood Disorders Section109: is a semi-
structured, clinician-based psychiatric interview for making diagnoses according to Diagnostic and 
Statistical Manual of Mental Disorders-5 (DSM-5).110  Prior versions are validated143;144 and demonstrate 
high inter-rater reliability for the diagnosis of major depression.111-114  
Activity Measure for Post-Acute Care Computer Adaptive Test (AMPAC-CAT): will be licensed for 
this study to evaluate the functional status of participants. The AMPAC has 269 items across three domains 
(basic mobility, daily activity and applied cognitive). The computer adaptive test, validated for use in the 
currently proposed post-acute care settings, requires a mean of 22 items from the item bank (administration 
time: 6 min.).87,88,115,116 The test will be administered, using a computer, by blinded research staff.117   
Health-Related Quality of Life (HR-QOL): will be measured using the EQ-5D-5L. 
Healthcare Utilization: We will collect data on the post-discharge healthcare utilizations, including in-
patient admissions to hospitals, and skilled nursing, acute and sub-acute rehabilitation facilities (Table 4).  
Moreover, we will collect data on utilization of out-patient mental health and physical rehabilitation 
services (Table 1).  We will evaluate these measures using existing methodology from our prior research in 
ARF survivors.118-121  
 
Table 4. Secondary outcomes 
 
Brief Cope: Coping strategies will be assessed using the self-reported 28-item Brief Cope Scale.94 The 
scale is a valid and reliable, used in medical populations, with strong measurement properties.94,120,122 It 
will assess active (e.g. problem solving) versus avoidant coping (e.g., behavioral disengagement, self-
blame).  
Description 
Instrument 
(# items; time to complete (minutes)) 
Baseline 
Week 6 
End of 
Intervention 
Depressive 
Symptoms 
HADS (7 items; 2min) 
PHQ-8 (8 items, 2min) 
SCID-5a (30 min) 
x 
 
 
x 
x 
x 
x 
Functional status 
AMPAC-CAT(~22 item; 6 min) 
Return to baseline work/activity (8 items; 3 min) 
x 
 
x 
x 
Health-Related  
Quality of Life 
EQ-5D-5L (2 min) 
 
 
x 
Employment status 
 
 
 
x 
Health Care 
Utilization and 
Estimated Costs 
Admission to hospital, nursing & rehabilitation 
facilities; plus mental health & physical rehab 
utilization (8 min) 
 
 
x 
Survival status 
Patient/Proxy (<1 min) 
 
 
x 
Coping Style 
Brief Cope (28 items; 10 min) 
x 
 
x 
Social Engagement 
BADS (25 items; 5 min) 
x 
 
x 
Resilience 
CD RISC (25 items; 10 min) 
x 
 
x 
Cognitive Function 
MoCA-BLIND ( 8 questions; 5 min) 
 
 
x 
PTSD 
IES-R (22 items; 6 min) 
 
 
x 
Abbreviations: HADS= Hospital Anxiety and Depression Scale, SCID-5= Structured Clinical Interview for DSM-5 (Mood 
Disorders Section only), AMPAC-CAT= Activity Measure for Post-Acute Care--Computer Adaptive Test, BADS= 
Behavioral Activation for Depression Scale, CD RISC= Connor-Davidson Resilience Scale 
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Behavioral Activation for Depression (BAD) Scale: This 25-point scale95 assesses social engagement and 
other aspects of behavioral activation. We demonstrated BADS’s validity in medical populations with 
depressive symptoms and its sensitivity to change with depression treatment.16  
Connor-Davidson Resilience Scale (CD RISC): This 25-item scale96 assesses resilience. It has been 
validated in a variety of patient populations and specifically used in research involving ARF 
survivors.102,105,106 
Adherence to the BA-R Intervention: will be evaluated as done in prior studies83,85 by: (1) measuring the 
number of phone attempts needed by the OT to reach the participant for each session, and (2) calculating 
the proportion of sessions fully completed (with sub-analysis for number partially completed).   
Montreal Cognitive Assessment (MoCA) – BLIND: is a validated phone-based version of the original 
MoCA,123 a rapid screening instrument for mild cognitive dysfunction. The MoCA - BLIND assesses 
different cognitive domains including attention and concentration, memory, language, conceptual thinking, 
calculation and orientation. It will take 5 minutes to administer the MoCA-BLIND. 
Impact of Events Scale – Revised (IES-R): This is the most commonly used instrument for assessing 
PTSD symptoms in ARF survivors.107 It has 22 items, is reliable and valid.124  
 
c. Statistical plan including sample size justification and interim data analysis. 
 
Sample Size: As a pilot RCT, we aim to enroll a convenience sample of ~1.5 patients/month, for a total of 
54 patients (based on 36 months of recruitment; see Timeline-Candidate Statement). Extensive experience 
enrolling ARF patients in prior studies by our group10,121,125-127 suggests this rate is feasible for a K-23 
award at this study site. We expect an overall <15% missing completion rate due to mortality and loss to 
follow-up (in our prior study of >500 ARF survivors, loss to follow-up was 2% with 7% mortality at 6 
months125), thus, we expect 54 patients to complete the intervention. With 54 participants (27 in each 
group), assuming 5% alpha, 80% power and HAD SD of 4.2 points based on our prior research in ARF 
survivors89,90, for our secondary aim of efficacy, we can detect a 3.1 point difference in HADS score 
between the 2 treatment groups, which approximates HAD’s 2.9 point minimum important difference 
(MID) in ARF survivors,128 This proposed enrollment rate and sample size is consistent with existing 
pilot/feasibility trials in ARF research.101,129,130 
 
Statistical Analysis 
Hypothesis 1a: A 12-week BA-R intervention in ARF survivors will be feasible, as demonstrated by an 
average accrual rate of 1.5 patients per month, completion of >80% of the intervention phone calls, and 
<15% of enrolled patients lost to follow-up for outcomes assessments at end of the 12-week intervention. 
We will assess the total number of intervention phone calls completed per patient as a proportion of the 
number of intervention phone calls each patient is intended to complete (i.e., 9 intervention calls – weekly 
during first 6 weeks and bi-weekly for second 6 weeks of the 12-week protocol). We also will assess total 
number of intervention phone calls completed by all study participants as a proportion of total intervention 
phone calls expected in the study. We will calculate the number of patients completing the 12-month 
follow-up session as a proportion of the number of patients enrolled to measure loss to follow-up.  
 
Hypothesis 1b: At the end of the 12-week BA-R intervention, ARF survivors in the BA-R versus “usual 
care” group will demonstrate decreased depressive symptoms, less impairments in physical function and 
quality of life, and reduced healthcare utilization. Analyses will follow a modified intention-to-treat 
principle and a 2-tailed p<0.05 is statistically significant. Patient mortality is expected to occur infrequently 
(see Sample Size above) and not to differ by treatment vs. control group; therefore, all analyses will be 
conducted for 12-week survivors only. The analysis will include separate comparisons of the effect of the 
BA-R intervention vs usual care control on each of the blinded outcomes in Table 4. These analyses will 
estimate the average treatment effect, i.e. the difference in the mean 12-week outcome comparing the BA-R 
intervention to the usual care control, using the precise locally efficient augmented simple estimator 
(PLEASE) described in Colantuoni and Rosenblum[REF: 135]. This method for estimating the average 

 
 
 
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treatment effect is similar to the analysis of covariance (ANCOVA) approach in that it incorporates the 
baseline outcome (if measured) which, if correlated with the 12-week outcome, can improve the precision 
of the estimated average treatment effect [Ref 134]. This method also accounts for more general patient 
drop-out models than the ANCOVA approach. Specifically, the ANCOVA approach is valid under 
completely at random drop-out, whereas the PLEASE is valid under missing at random drop-out, i.e. when 
patient drop-out differs by treatment group or across levels of the baseline outcome or other measured 
variables at baseline. The PLEASE requires a priori specification of three models: an outcome regression 
model (fit separately for each treatment group) that will include age, gender and the baseline outcome (if 
measured), a propensity score model that will include age, gender and the baseline outcome (if measured) 
and a drop-out model (fit separately for each treatment group) that will include age, gender, and the 
outcomes measured at baseline (HADS, Brief Cope, CD RISC, BADS). As exploratory analyses, the 12-
week outcomes (e.g. HADS scores) will be summarized (summary statistics including counts of missing 
values and histograms) and the correlation of the baseline (if appropriate) and 12-week outcomes will be 
computed, separately by treatment arm.  Patient mortality, drop-out and missing data will be described for 
all variables, separately for treatment vs control groups. Patient characteristics will be compared between 
those with vs. without missing outcomes (due to drop-out and missing values).136-138 
 
A series of secondary analyses will be conducted to improve our understanding of the changes in the 
outcomes over time under the BA-R intervention and usual care control and to improve the design of 
subsequent larger randomized trials evaluating the effect of the BA-R intervention.  Specifically, the 
outcomes over time within each treatment group will be visualized using spaghetti plots to display each 
patient's data with the mean outcome over time trajectory over time highlighted.  Longitudinal linear 
regression models for the longitudinal outcomes (i.e. baseline, 6-week and 12-week outcomes) will be 
constructed that account for time (factor), treatment and the interaction of treatment and time.  These 
longitudinal models will be fit using weighted least squares and will allow for the possibility that the 
variance in the outcomes can change over time and that outcomes measured on the same patient over time 
may be correlated.  In addition, we will explore the prognostic ability of other baseline variables (e.g. age, 
sex and history of depression) for the 12-week outcomes using the method described by Colantuoni and 
Rosenblum.135 Specifically, we will compute the leave-one-out cross-validated relative R-square which 
compares the  R-square obtained when modeling the 12-week outcomes as a function of selected baseline 
variables, separately for each treatment arm, to that obtained by predicting the 12-week outcomes with the 
treatment arm specific mean.  The statistic (1 – 1/relative R-square) is roughly the sample size reduction 
that can be achieved if the selected baseline variables are incorporated into an adjusted treatment effect 
estimator compared to using an unadjusted estimator.  This assessment will provide relevant information to 
improve the design and analysis of subsequent larger randomized trials evaluating the effect of the BA-R 
intervention; specifically, by informing which additional prognostic baseline variables to include in the 
ANCOVA approach described above to further improve the precision of the estimated treatment effects. 
 
Hypothesis 1c: We will conduct qualitative research, using thematic analysis, to identify key barriers and 
facilitators to engaging with the BA-R intervention, as well as perceived satisfaction, acceptability and 
feasibility of BA-R. All interviews will be audio recorded using a digital recorder and subsequently 
transcribed on a rolling basis. Using a data-driven approach, the first five interviews and associated 
interviewer field notes will be independently read by Dr. Parker and a second coder with expertise in 
qualitative research methods. The data will be segmented by identifying information pertinent to the 
research question then categorizing and giving identifying names (codes) to the patterns that emerge. 
Following the review of the five initial interviews, the two investigators will meet to discuss common 
findings and key themes. A code book will then be developed to guide the analysis of the transcripts 
through an iterative process of discussion and review. Transcripts will be reviewed on an ongoing basis to 
identify when thematic saturation is reached, defined by at least 3 interviews without additional 
information. Nvivo software will be used to organize the data for analysis. Coding will be compared 

 
 
 
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between the coders using percentage agreement and Cohen’s kappa coefficient. Discrepancies will be 
reviewed and resolved through discussion between reviewers and a third review, if needed. 
 
Hypothesis 2a: Increased resilience, adaptive coping, and social engagement are associated with fewer 
depressive symptoms using the combined patient cohort from the BA-R and control groups in Aim 1. Our 
primary outcome is depressive symptoms from the Hospital Anxiety and Depression Scale (HADS). First, 
descriptive statistics (i.e. mean, standard deviation, histograms) will be performed for the baseline HADS 
and the exposure and confounding variables. Next, a bi-variable analysis will be conducted for the HADS 
vs the baseline exposure variables for Aim 1 (i.e., CD-RISC 10, Brief COPE, BADS) using linear 
regression. In multivariable analyses, we also will include potential confounding variables (Table 1), 
including no more than 4 covariates in each model to avoid overfitting with sample size 54 (after 
accounting for mortality and loss to follow-up). These analyses will be conducted for all patients in the 
combined cohort in Aim 1. 
 
Hypothesis 2b: At the end of the 12-week intervention, ARF survivors in the BA-R versus “usual care” 
control group will demonstrate improvements in coping, resilience and social engagement. Analyses for 
the comparison between the intervention and usual care groups will follow a modified intention-to-treat 
principle, with a 2-tailed p<0.05 is considered significant. Analysis will include separate comparisons of 
the intervention vs control for each of outcomes (Brief Cope, CD RISC, BADS), in accordance with the 
description above for Hypothesis 1b.  
 
Hypothesis 2c: We will conduct qualitative research, using thematic analysis, to identify the role of 
resilience, coping, and social engagement in recovery from ARF. See analysis plan above for Hypothesis 
1c. This analysis will include all patients in the combined cohort from Aim 1. 
 
Hypothesis 3: The HADS and PHQ-8 will adequately discriminate depressive symptom severity vs. the 
SCID-5 “gold standard” using the combined patient cohort from the BA-R and control groups in Aim 1. 
All analyses will be conducted using only the 12-week outcomes data. The RCT inclusion criteria (in Aim 
1), which establish the patient cohort for Aim 3, include only patients with PHQ-2 ≥2 (i.e., at least mild 
depressive symptoms). Therefore, for Aim 3 analyses, we will categorize depressive symptoms based on 
severity category for the SCID-5 (mild vs moderate to severe). We will then examine  the screening 
characteristics of HADS and PHQ8 total scores vs the SCID-5 using a receiver operating characteristics 
(ROC) curve, including the area under the ROC curve (AUC), and sensitivities, specificities, and positive 
and negative predictive values at each HADS and PHQ8 total-score cut point. Our sample size (N=54 
patients) is adequate to permit an assessment of criterion validity that is rated, at least, as “good” quality 
according to the COSMIN standard for psychometric analyses.131 In addition to assessment of criterion 
validity, we will assess internal consistency of the PHQ-8 using Chronbach’s alpha, with a result of >0.7 
and <0.95 indicating “good” quality as per COSMIN132 (HADS has an existing publication demonstrating 
good internal consistency in ARF survivors so no such analysis will be repeated for HADS)133.  
 
d. Early stopping rules. 
 
There will be no interim analyses to determine early stopping for efficacy or futility with respect to the 
main efficacy hypothesis. The primary outcome for this study is feasibility. 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
1) Depression: Participants will be asked questions about depression using the PHQ-8, HADS and the 
SCID. While asking questions, we may detect that the patient has worsening depressive symptoms.  
 

 
 
 
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2) Breach of confidentiality: We will be collecting data about the participant, and hence, there is a risk of 
breach of confidentiality.  
 
b. Steps taken to minimize the risks. 
 
Depression (PHQ-8, HADS and SCID): All potential participants who have worsening depression 
symptoms will be informed that they may be depressed and advised to consult with their health care 
provider. 
 
If there is any potential concern regarding safety of a participant, a physician on our study team will 
become involved. The research assistant will be instructed to take the steps outlined in Figure 2 below. 
− Complete a Serious Adverse Event Report (SAE) form documenting the outcome of this questionnaire 
and subsequent action taken. 
− If unsure about the patient’s risk, contact a study physician to notify them immediately and discuss 
action to take.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Figure 2. Suicide Risk Management Protocol 
 
 

 
 
 
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Breach of confidentiality: We will keep all participant information confidential in accordance with Public 
Health Services Act (42 USC 299a-1(c)).  There is a low risk of a breach of confidentiality.   
 
We will maintain subject confidentiality by keeping all study files in locked cabinets in locked rooms 
accessible only to study personnel with permission to examine study files. Electronic data will be password 
protected with daily back up procedures.  Once data is entered into an analytic file, all identifying 
information will be removed.    
 
c. Plan for reporting unanticipated problems or study deviations. 
 
The primary investigator (Dr. Parker) is a board-certificated Internal Medicine physician practicing in the 
intensive care unit at Johns Hopkins. She will be involved in the daily conduct of the clinical trial and 
closely supervise the daily screening for patient eligibility, informed consent, and study procedures such as 
outcomes assessments and safety monitoring during the trial. Consequently, immediate knowledge of any 
unanticipated problem or study deviation that may arise will be available to the P.I. (Dr. Parker) on a timely 
basis for immediate action and reporting to the IRB as necessary. If Dr. Parker is unavailable, the study will 
maintain a list of clinicians who are co-mentors to Dr. Parker on this study who can provide medical 
guidance.   
 
If clinically important, unanticipated adverse problems or clinically important study-related, serious 
adverse events occur, they will be recorded on a designated case report form.  All events that are serious 
and unanticipated, or study-related and adverse will be reported to IRB within the required reporting 
timeline.  
 
Definitions: 
Adverse event: any untoward medical occurrence associated with the use of a drug in humans, whether or 
not considered intervention related. 
Serious Adverse Event (SAE) - an adverse event will be considered "serious" if, in the view of the 
investigator, it results in any of the following outcomes:  death, a life-threatening adverse reaction, re-
hospitalization, a persistent or significant incapacity, or substantial disruption of the ability to conduct 
normal life functions.  
 
Suspected Adverse Event - any adverse event for which there is a reasonable possibility that the drug 
caused the adverse event. 
 
Unexpected Adverse Event - an adverse event or suspected adverse reaction is considered "unexpected" if 
it is not listed in the investigator brochure or is not listed at the specificity or severity that has been 
observed; or, of an investigator brochure is not required or available, is not consistent with the risk 
information described in the general investigational plan or elsewhere in the current application.  
 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
All patient data will be confidential and secure due to physical and electronic data security measures, 
including locked offices and locked filing cabinets for records and computers, and password protection for 
computers and electronic data storage.  All participant-identifying information will be removed from the 
dataset before analysis. Only study staff who are required to, will know the linkage between the unique 
identifier and participant-identifying information. We will keep all patient information confidential in 

 
 
 
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accordance with Public Health Services Act (42 USC 299a-1(c)). There is low risk of a breach of 
confidentiality. 
 
e. Financial risks to the participants. 
 
There are no expected financial risks to the participants. 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
Currently, there are few therapeutic options with proven, or potential, efficacy to prevent or minimize 
depressive symptoms in acute respiratory failure survivors.  Hence, this study offers important new 
knowledge through testing the BA-R intervention in this patient population. The BA-R intervention has 
been demonstrated to improve depressive symptoms in other chronically ill populations. Given the 
prevalence of depressive symptoms in acute respiratory failure survivors, gaining information regarding the 
feasibility and potential benefit of BA-R in this pilot study has great importance. This therapy is especially 
ideal in acute respiratory failure survivors because it can be delivered via phone with only 2 home visits 
required by PT and OT. The potential benefits far outweigh the minimal potential risks of this intervention. 
 
If successful, the use of BA-R therapy may improve post-acute respiratory failure depressive symptoms, 
improve physical function and decrease healthcare utilization while improving quality of life.  
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed 
bonus, and any proposed reductions or penalties for not completing the protocol. 
 
For each assessment during the study, both intervention and control group patients will be remunerated as 
follows: $25 for baseline assessment prior to intervention period, and $50 for assessment at the end of the 
intervention period.  
 
In addition, the intervention group only will be remunerated $100 for completion of all intervention visits.   
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
There will not be any additional costs to participants beyond routine financial obligations for their 
hospitalization.   
 
 

 
 
 
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