Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers
Phase: NA
Conditions: Acute Brain Injuries
Sponsor: Massachusetts General Hospital

 
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PARTNERS HUMAN RESEARCH COMMITTEE DETAILED PROTOCOL 
 
Principal Investigator:  
Ana-Maria Vranceanu, PhD 
 
Protocol Title:  
Recovering Together: Building resiliency in dyads in patients 
admitted to the Neuroscience Intensive Care Unit (NICU) and their 
caregivers  
 
Funding:  
 
 
National Institute of Nursing Research  
 
Version Date:  
 
8/6/2019 
 
 
I. BACKGROUND AND SIGNIFICANCE 
 
Acute neurological illnesses (ANIs) are common, costly and often lead to long-term 
disability. ANIs are biologically distinct injuries that disrupt the normal function of the brain. 
The most common ANIs in Neuroscience Intensive Care Units (NICU) include cerebrovascular 
(stroke/hemorrhage and brain aneurysm), structural (tumors and lesions/brain masses), and 
traumatic (TBI) brain injuries. NICU admissions for ANIs are prevalent (e.g., 795,000 acute 
stroke/year; 275,000 acute TBI/year) and costly1,2; post NICU prolonged rehabilitation is 
common3. 
ANIs are associated with chronic emotional distress in both patients (pts) and caregivers 
(cgs). Although biologically heterogeneous, ANIs are unified by sudden onset, and substantial 
emotional distress in both pts (e.g., 12-43% anxiety4-7; 10-58% depression4,7,8; 20-29% post-
traumatic stress PTS5,9) and family cgs (27-60% depression, anxiety or PTS 4,10,11). 
These symptoms often become chronic and treatment resistant26,27. 
Pt and cg factors interact and influence physical and emotional outcomes in both pts and 
cgs. Post ANI emotional distress is associated with pts’ poor medical adherence28, slower 
recovery28-30, higher mortality29-31, and need of more caregiving assistance32, which further 
increase cgs’ distress30,33,34 and own risk for morbidity35,36 and mortality37; in turn cgs’ 
emotional distress interferes with ability to provide high-quality care to pts38,39 and negatively 
impacts pts’ outcomes. 
Current management of ANIs does not meet the psychological needs of pts and cgs for 3 
reasons40-51. First, although recognition of the emotional burden associated with NICU 
admission has increased, and some NICUs have social workers available to assist pts and cgs, 
there are no formal screening methods for emotional distress routinely integrated in practice 
during hospitalization, when the primary focus is on medical care and survival; further, there are 
no formal evidence-based treatments integrated within the medical care. When social workers 
are included to help pts and cgs, the care is brief and occurs only during hospitalization. When 
referrals to mental health services are provided to families at discharge, few will access 
additional treatment due to burden associated with traveling outside of home. Second, 
psychosocial interventions available for ANI pts or cgs are limited in that they are delivered 
when symptoms are already chronic, address only one emotional illness (e.g., depression or 
anxiety or PTS), and/or are focused on a single member of the pt-cg dyad. Even interventions 
labeled as “dyadic,” which include pts and cgs, typically address only the pts’ needs and do not 

 
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focus on cg outcomes or on the dyad’s interpersonal communication and bond/relationship12,52. 
These interventions are not consistent with the dyadic framework22 which specifies that dyadic 
interventions should account for the interdependence between pt and cg psychosocial factors 
including their interpersonal bond by ensuring that both pts and cgs attend each session together, 
and by targeting improvement in outcomes for both pts and cgs. Third, most interventions are 
delivered using uniform protocols. However, the needs of ANI dyads are heterogeneous due to 
varying levels of post ANI impairment, identity of the cg, context and stage of life. A recent 
systematic review52 urged for the development of dyadic interventions that address the needs of 
both pts and cgs and are tailored to the specific needs of each ANI dyad. 
We developed the first dyadic skills-based intervention – Recovering Together - to prevent 
chronic heightened emotional distress in at risk ANI pt-cg dyads. The “Recovering 
Together” program is informed by the theoretical response-shift framework of adaptation to 
acute illness53 (successful adaptation implies recalibration of values and life goals), the family 
strength vulnerability model24 (within dyads relational systems have strengths and weaknesses 
in how they cope with life events), the dyadic longitudinal model22 (distress travel from one 
member of the dyad to the other across time), the APIM model54, and the resiliency framework17. 
The program is in line with recent recommendations for skill-based interventions for critical care 
patients, and uses preliminary data collected by our team for the past 3 years4, 13-15. The 
intervention teaches pts and cgs resiliency factors that are associated with well-being after 
trauma for both pts and cgs: mindfulness – the ability to stay present and defer judgment in the 
face of adversity18; coping– the arsenal and application of one’s behavioral, cognitive, and 
emotional strategies to manage stress19; social support –empathetic interpersonal interactions 
that meet one’s emotional and functional needs20; self-efficacy – perceived ability to adapt under 
adversity21 and positive dyadic interpersonal communication to increase interpersonal bond12. 
Informed by the aforementioned theoretical models, our conceptual model hypothesizes that by 
teaching both members of the dyad resiliency and interpersonal communication skills (e.g., 
Recovering Together) we will be able to sustainably decrease emotional distress in both 
members of the dyad 
 
In addition, our team has an established record of collaboration on published or ongoing 
investigations. Emotional distress is prevalent in dyads, interdependent between pt and cg, 
and negatively associated with resiliency factors4. Our team conducted a cross-sectional study 
of pt-cg dyads in the NICU (40% stroke, 30% tumor). 75% pts and 84% cgs approached agreed 
to participate. 74% pts had been intubated at one time during NICU admission, and 2/3 were 
discharged home. Rates of clinically significant symptoms of depression, anxiety and PTS did 
not differ between pts (24%, 43%, 21%) and cgs (24%, 46%, 17%), or by any demographic or 
medical characteristic. Dyadic modeling showed that for both pts and cgs, mindfulness and 
coping impacted both self and partner’s emotional distress symptoms. We showed: 1) feasibility 
of recruitment; 2) high emotional distress in dyads; and that 3) modifiable resiliency factors 
(mindfulness and coping) are intervention targets interdependently associated with distress in pts 
and cgs, regardless of the identity of cg (e.g., spouse, friend, etc).  
Resiliency factors are associated with lower emotional distress in NICU dyads13. Our team 
found that resiliency factors of mindfulness, coping, self-efficacy and patient-caregiver 
interactions were associated with decreased emotional distress in dyads of ANI. This study 
confirms mindfulness, coping as intervention targets and provides novel evidence on self-
efficacy and patient-caregiver interaction as additional important intervention targets.  

 
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ANI pts have greater anxiety than cancer patients at early diagnoses14. We led the first 
cross-comparison study of emotional distress among dyads with ANI and cancer. This study 
supports the priority of addressing emotional distress in ANI dyads as has been emphasized for 
cancer dyads.  
Clinically significant emotional distress in one member of the dyad at hospitalization 
predicts chronic emotional distress in at least 1 of the dyad members 3 and 6 months 
later55. Our team has an ongoing prospective study of dyads with ANI. Retention rates for dyads 
due for assessments at 3 and 6 months thus far are 84% and 91% for pts and 87.7% and 95.7% 
for cgs, confirming our ability to retain post-ANI participants. Within each dyad, if one member 
screens in for clinically significant symptoms for any diagnosis (i.e., depression, anxiety or 
PTSD) at hospitalization there is good sensitivity and specificity that one member of the dyad 
will endorse clinically significant symptoms 3 months later. This study shows a reliable method 
for identifying dyads of patients at risk for chronic heightened emotional distress by identifying 
dyads in which either the pt or cg screens in for heightened emotional distress (symptoms of 
depression, anxiety or PTSD).  
Caregiver gender moderates the prospective association of resiliency factors to emotional 
distress87. This study found that at the time of admission resiliency factors have main effects on 
emotional distress, with no differences by cg gender. However, significant interaction effects 
emerged prospectively such that male cgs with high mindfulness at baseline demonstrated lower 
levels of emotional distress at 3 and 6 months later than did males with low mindfulness (p = 
0.026 and p <0.013). Similarly, women cgs with high intimate bond at baseline reported the 
lowest levels of depression symptoms 3 and 6 months later (p < 0.020). This study confirmed the 
need to assess and address resiliency factors early in the recovery process, and identified 
important gender differences to be accounted for in intervention development.  
Recovering Together; Developing a novel dyadic resiliency skills program for ANI pt-cg 
dyads at risk for chronic emotional distress15. With funding from American Heart 
Association, we conducted 20 qualitative interviews with pt-cg stroke dyads at risk for chronic 
emotional distress during NICU hospitalization. We also conducted additional clinical interviews 
with 10 pt-cg dyads representative of other ANI diagnoses. 83% dyads approached agreed to 
participate. Pts (23) and cgs (25) were mostly women. Dyads were mostly spouses and mothers-
daughter. Data was analyzed with Nvivo10. Main themes did not differ by medical diagnoses: 1) 
most challenging and distressing experiences: uncertainty about future, anxiety, depression, sleep 
difficulties, worries about the future, guilt, managing job with caretaking, making treatment 
decisions, lack of predictability; 2) concerns about interpersonal relationships (self-image, role 
changes, role fulfillment); 3) fear of recurrence; 4) adjusting to sequelae. Dyads noted interest in 
a resiliency program (30/30) and preferred a combination of in person and live video sessions 
(30/30). Dyads learned about resiliency skills (e.g., name, description and goal) and agreed they 
would be helpful to them. They also noted interest in learning about: survivorship plans, 
adaptation to deficits (present or anticipated), and return to normal living. We found no thematic 
differences between stroke dyads and other ANI dyads. Challenges associated with embracing 
the caregiver role emerged as a theme while differences by the identity of caregiver (e.g., spouse 
vs. friend, vs parent) did not. Themes associated with the gender of the cg emerged and have 
been incorporated in the intervention.  
Nurses perception of the needs for and feasibility of “Recovering Together for ANI 
families25. We conducted 2 focus groups (N =15) with NICU nurses who provided feedback on 
the qualitative findings from our 30 ANI dyads and shared own experiences and opinions on 

 
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implementation and scalability of the intervention including nurse involvement. Nurses 
concurred with pts experiences, and suggested strategies to recruit and retain dyads for the study, 
which are now included in the methodology section of the current grant proposal. Studies 3.6 and 
3.7 represent the building blocks for the development of our Recovering Together program and 
manual. Nurses provided edits and contributed to the iterative development of the manual. These 
studies also confirm feasibility of conducting the pilot RCT proposed through this R21. 
  
II. SPECIFIC AIMS 
 
The current study has the following objectives:  
 
Aim 1: To determine the feasibility of recruitment, feasibility of program delivery, 
program credibility, and program satisfaction using evidence-based benchmarks. 
 
Hypothesis 1: We hypothesize that > 75% of the dyads approached will agree to participate. 
Hypothesis 2: We hypothesize that > 75% of dyads who start the intervention will complete at 
least 4 sessions.  
Hypothesis 3: We hypothesize that > 75% of participants will report average credibility 
(Credibility and Expectancy Questionnaire) scores greater than the scale’s midpoint. 
Hypothesis 4: We hypothesize that > 75% participants will report average satisfaction (Client 
Satisfaction Scale) scores greater than the scale’s midpoint.  
 
Aim 2: To demonstrate a proof of concept that the Recovering Together program can 
sustainably improve emotional distress [Hospital Anxiety and Depression Scale; HADS], 
Post Traumatic Symptoms (PTS) [PCL-S], resiliency variables (mindfulness, coping, social 
support and self-efficacy) and interpersonal factors (interpersonal bond). 
 
Hypothesis 1: We hypothesize that participation in the Recovering Together Program will be 
associated with a more potent decrease in emotional distress and PTS compared to participation 
in the educational program (control), and that these improvements will maintain at 3 month 
follow up.  
Hypothesis 2: We hypothesize that Recovering Together Program will be associated with a more 
potent increase in resiliency variables (mindfulness, coping, social support, self-efficacy) and 
interpersonal factors (interpersonal bond) compared to participation in the educational program, 
and that these improvements will maintain at 3 month follow up.  
 
For this feasibility pilot RCT, our primary outcomes (feasibility, credibility and satisfaction) will 
be assessed in Aim 1. Our secondary outcomes in this trial are: emotional distress, PTS, 
mindfulness, coping, social support, self-efficacy, and interpersonal bond, and will be assessed in 
Aim 2.  
 
 
III. SUBJECT SELECTION 
 
All participants will be recruited from the Massachusetts General Hospital Neuroscience ICU, 
using IRB approved recruitment materials. 

 
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Inclusion/Exclusion Criteria 
 
Eligible dyads (Pts and Cgs) must meet the following inclusion criteria: 
1) Age 18 or older  
2) English fluency and literacy 
3) Access to high speed internet for video sessions 
4) Pt with an informal cg (family or friend who provides unpaid care) available and 
willing to participate 
5) Hospitalized with an ANI within 1-2 weeks (pt) OR primary cg of a pt currently 
admitted with an ANI 
6) Either pt or cg have clinically significant symptoms of depression, anxiety, and/or 
PTS 
 
One or more of the following exclusion criteria will render a pt ineligible: 
1) Permanent and severe cognitive impairment severe enough to impede participation – 
This will be determined by trained study staff through an assessment conducted as 
part of usual care and that includes the MMSE (score of <23) and GCS (score of 
<10). Nurses and study staff are trained and use these measures as part of NICU care.  
2) Dyads where the pt is anticipated to die or to never be able to participate due to 
medical sequelae. This will be determined by nurses.  
 
All adult patients and family caregivers, satisfying all inclusion criteria, are eligible for 
enrollment in this study regardless of sex, race, or ethnicity. Vulnerable populations will not be 
recruited. 
 
Recruitment 
 
Patients will be recruited from the NICU at MGH from the medical team (nurses). Recruitment 
will be facilitated by the nursing team who will introduce the study to eligible dyads and who 
will also assess whether pts are able to consent, consistent with medical presentation, and 
cognitive status. Trained study staff will be administering the MMSE and nurses will administer 
the GSC, to all patients and will refer only dyads where the patients scores are higher than the 
established cut off scores on these measures. Consistent with NICU practice, nurses will 
administer the GSC. They will refer participants to the study only if they are cleared medically 
and cognitively. The team will page the RA using the secure Voalte system used by our team and 
nursing staff, when both the pt and cg are present and able to hear more about the study. The RA 
will only approach pts identified and cleared by the medical team. The RA will ensure eligibility 
of both pts and cgs based on the additional inclusionary and exclusionary criteria depicted above. 
The RA will finalize the screening and conduct informed consent. All participants will receive a 
physical copy of the informed consent form which has the contact information for the PI. If cgs 
cannot be reached in person in the hospital, they will be contacted via phone for screening and 
completion of informed consent. Cgs will be given a copy of the consent form to review while 
discussing the study over the telephone. We will fax or securely e-mail the consent form prior to 
obtaining consent. Cg will return a signed copy of the consent form. If a patient who is interested 
in enrolling in the study is unable to provide a full written signature due symptoms from their 

 
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ANI (unable to move or use their arm to write), then we will ask them to make their mark on the 
signature line in the consent form. People who cannot make their mark on the consent form can 
indicate consent by other means, e.g., orally, nodding their head, etc. The means by which 
consent was given by the subject will be documented in the consent form and research record.  
Patients and caregivers will be considered enrolled when they sign the consent form with the 
study staff. Please see details on the informed consent process in the next section, Subject 
Enrollment (Section IV). These procedures will be completed in a private medical space. 
 
Participants will be explicitly informed that this intervention is a research study that does not 
constitute individualized, personal care. The intervention is a broad-based method of training that 
is not tailored to any particular individual. Should any participant seek formal mental healthcare, 
study staff will refer them to either MGH Psychiatry, as appropriate.  
 
We will recruit pts with any type of ANI and their cgs, ensuring representation of all NICU 
diagnoses. All cgs will be recruited within the first week of the pts’ hospitalization. Pt’s medical 
team will also alert the research assistant whether they anticipate that the patient might be able to 
participate in the study at a future point during the hospital stay. In situations where patients are 
unable to consent due to the severity of the ANI, we will enroll the informal cg and return to 
enroll the pt as soon as their mental capacity improves. The research assistant will not approach 
patients who are not mentally or physically capable to participate. This study does not include 
participants with impaired decision making.  
 
We will not include patients who do not have a caregiver. Informal caregivers will be designated 
by the health care proxy and verbally confirmed by the patient. Nurses will assist the study team 
with identifying the patient’s health care proxy. 
 
Eligible cases may also be identified by daily screening of Epic admission reports. 
 
The study team will keep track of all pts and cgs approached who refuse to participate (along 
with reasons for refusal), as well as those who were not approached and reasons why. 
 
When the RA approaches a patient, patients and caregivers will be given the choice of watching 
a short recruitment video that contains testimonials from previous patients.  
 
The recruitment process was developed and refined through prior research for the past 2 years.  
 
 
IV. SUBJECT ENROLLMENT 
 
Participants will be referred to the study by the nursing team who will ensure that patients are 
medically and cognitively able to participate. Eligible dyads will next be screened, consented, 
and enrolled by the research assistant.  
 
After determining eligibility, study staff will meet with potential dyads to review the informed 
consent document. Patients who cannot make their mark on the consent form because of 
lingering symptoms from the ANI can indicate consent by other means, e.g., orally, nodding 

 
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their head, etc. The means by which consent was given by the subject will be documented in the 
consent form and research record. If cgs cannot be reached in person in the hospital, they will be 
contacted via phone to complete informed consent. Cgs will be given a copy of the consent form 
to review while discussing the study over the telephone. We will fax or securely e-mail the 
consent form prior to obtaining consent. Cgs will return a signed copy of the consent form. After 
the document has been reviewed, study staff will answer any and all questions the pt or cg may 
have. Once all questions have been addressed, each member of the dyad will sign the consent 
form, which will include a description of all study procedures, the option to receive text message 
reminders, information about potential risks and benefits of participation, and study contact 
information (including that of the IRB) in case questions arise at a later time. The consent form 
will also explicitly state that study participation is voluntary, and that participants may refuse to 
answer any questions that make them uncomfortable, and may discontinue participation at any 
time. In addition, participants will be assured that withdrawal from the study will not 
compromise their medical care in any way. 
 
As informed consent is a continuous process, participants will be given a copy of the signed 
informed consent document, and will be invited to ask questions about their participation at any 
point over the course of the study.  
 
Following a study enrollment and baseline assessment, dyads will be randomly assigned to either 
the newly developed psychosocial intervention or to the educational program (control) using a 
random number sequence generator to ensure comparability between groups. We will document 
time between assessment and intervention initiation, and analyze as a predictor of study 
outcomes as needed. Randomization will be developed by the statistician, without any input from 
the rest of the team.  
 
 V. STUDY PROCEDURES 
 
After enrollment, participants will complete study assessments. All subjects will be given 
baseline psychological and behavioral assessments that will assess depression, anxiety, PTS 
symptoms, and other psychological constructs. Assessments will be administered online, using 
the REDCap system. Subjects may choose to fill out these questionnaires on-site, or to fill them 
out at home on a personal computer or other Internet-equipped device. This assessment includes 
demographic information and a battery of psychological questionnaires. We will also collect 
information about important clinical variables including duration of acute hospitalization. All 
questionnaires are itemized below: 
 
Administered at Baseline Only: 
Demographics 
Prior Mental Health History questions  
Credibility Questionnaire 
 
Administered at Baseline, Post-Intervention, and Follow-up: 
Medical history information from LMR (i.e., prior ANI status, current psychotropic meds, 
comorbid medical conditions, etc.) 
Post-Traumatic Stress Disorder Checklist (PCL-S)29 

 
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Hospital Depression and Anxiety Scale (HADS)30 
Measure of Current Status Part A (MOCS-A)31 
The Cognitive and Affective Mindfulness Scale (CAMS)32 
World Health Organization Quality of Life (WHOQOL-BREF)33 
Dyadic Relationship Scale (DRS) 
Experience in Close Relationships – Relationship Structure (ECR-RS) 
 
Administered Post-Intervention and Follow-up Only:  
Client Satisfaction Questionnaire (CSQ-3)34  
 
The study staff will complete the following questionnaires to assess symptom severity for each 
patient at all 3 timepoints (baseline, post intervention and follow up): 
Modified Rankin Scale (mRS)35 [Pts only] 
Barthel Index36 [Pts only] 
 
After completing the baseline assessments, dyads will be randomized to either the newly 
developed psychosocial intervention or to treatment as usual. 
 
The psychosocial intervention entails 6 sessions, each 30 minutes. Both the pt and cg participate 
in each session. The intervention is manualized, and teaches dyads resiliency (mindfulness, 
social support, self-efficacy, coping skills) and interpersonal communications (interpersonal 
bond) skills. The first 2 sessions will occur in person, during hospitalization. The next 4 sessions 
are chosen from 5 available, depending on each dyad’s preference, and are delivered after 
discharge via secure live video. For the video sessions, dyads can participate from the same or 
different locations. During the in hospital sessions, dyads learn diaphragmatic breathing, 
mindfulness, self-care, and dialectics. During the video sessions, dyads learn how to identify 
negative thinking patterns and replace them with adaptive thoughts, how to communicate 
effectively and openly, how to engage in self-care, and how to accept things that can’t be 
changed. Participants in the intervention group will also receive treatment as usual. This may 
include meeting with nurses, physical therapists, medical doctors, and other members of the pt’s 
medical team. Treatment as usual may also involve administration of SSRI to those patients with 
motor problems.  
 
Those in the educational program (control) will receive general health information that mimics 
the Recovering Together Program, but without teaching any of the resiliency or interpersonal 
communication skills that are hypothesized to be responsible for improvement in emotional 
distress. The educational program will also have 6 sessions, 2 in-person dyadic visits in the 
NICU and 4 dyadic virtual visits following discharge. It controls for dose and support from 
clinician. Both members of the dyads participate in all sessions. The topics of each session 
include: education about the stress of the ANI on patient and caregiver; education on the 
importance of self-care; education on stress associated with discharge and home adjustment; 
education on the importance of following up with medical recommendations; education on 
interpersonal stress as part of adjustment to ANI; education on self-care. The educational 
program condition will ensure that patients will remain blind to intervention or control and 
increase confidence that improvement in outcomes are due to the active ingredients of the 
intervention and not confounds. Participants in the educational program will continue with their 

 
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current care. This may include meeting with nurses, physical therapists, medical doctors, and 
other members of the pt’s medical team. Treatment as usual may also involve administration of 
SSRI to those patients with motor problems. 
 
Participants in both groups will be given post-treatment psychological and behavioral 
assessments identical to those administered at baseline, in addition to the CSQ-3. As a baseline, 
participants will be given the option to complete post-treatment 
questionnaires on site or at home. Participants will be asked to 
complete questionnaires immediately after completion of the 
group intervention (T2), and 3 months (T3) after completion of 
the group intervention, in order to measure long term 
outcomes. Study staff will email these questionnaires to the 
participants via the REDCap system or give participants the option 
to complete them over the phone with a study staff member.  
 
 
VI. BIOSTATISTIC ANALYSIS 
 
We plan to conduct a RCT with patients from the Neuro-ICU. 
The main intervention goal is to provide dyads with resiliency 
and interpersonal communication skills necessary to optimize 
recovery. Dyads will be medically cleared by a member of the 
nursing staff. Nurses will then screen dyads for exclusionary 
cognitive criteria. Dyads will complete additional screening 
and baseline questionnaires with a trained research assistant. 
Dyads will be randomized to one of two groups 1) Psychosocial 
skills based intervention (Recovering Together), or 2) Educational 
Control.  
 
We chose our study measures based on our theoretical frameworks, strong psychometric 
properties in studies of patients with ANI, and feasibility in our prior work with ANI dyads. 
Measures will be collected at baseline, post-intervention, and at 3 month follow up. Data 
collection and management will be conducted with Research Electronic Data Capture. Dyads 
will be given the option to complete measures electronically, by paper and pencil, or telephone.  
 
 
1) Is the psychosocial skills-based intervention feasible, credible usable, and accepted by 
pts and cgs in the ICU? 
 
Our primary aim focuses on trial feasibility, acceptability, credibility and preliminary 
effect. In pilot studies, ≥30 participants are recommended per group to establish 
feasibility and detect larger effect sizes for ≥1 outcome. We plan to recruit 80 dyads (160 
participants), 40 dyads (80 participants) per arm to establish feasibility, acceptability, 
credibility and estimate effect size for emotional distress variables (primary quantitative 
outcomes). Assuming attrition of over 25% (in excess of what we experienced in our 
preliminary studies), we will have the necessary 30 dyads (60 participants) per arm. This 

 
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size is considered to yield stable estimates of M/SDs based on prior behavioral trial 
recommendations. Effect sizes from this study may overestimate power in future sample 
calculations. We chose study measures based on our theoretical frameworks, strong 
psychometric properties in studies of patients with ANI, and feasibility work in our prior 
work with ANI dyads. Feasibility will be reported as the percentage of patients enrolled 
in the study who complete at least 75% of the intervention sessions. Demonstration of 
feasibility will be assessed by the number of individuals who drop out of the study prior 
to completing the post- intervention assessment and the rate of missed sessions. If drop-
out rate or missed-session rate exceeds 25%, revisions to the intervention may be needed. 
We will also report number of patients approached, enrolled, randomized and who 
completed time 2 and time 3 to determine feasibility. 
2) Is the psychosocial skills-based intervention effective for pts and cgs in the ICU? 
 
Dr. Vranceanu developed the proposed study design in collaboration with the NICU 
study team (nurses, physicians, clinical interns) and an MGH psychologist who 
specializes in using mindfulness and emotion regulation in both chronic illness and 
medically healthy populations. With funding from the American Heart Association, we 
conducted 20 qualitative interviews with pt-cg stroke dyads at risk for chronic emotional 
distress during NICU hospitalization. We also conducted additional clinical interviews 
with 10 pt-cg dyads representative of other ANI diagnoses. 83% of dyads approached 
agreed to participate. Pts (23) and cgs (25) were mostly women. Dyads were mostly 
spouses and mothers-daughter. Dyads noted interest in a resiliency program (30/30) and 
preferred a combination of in person and live video sessions (30/30). Dyads learned about 
resiliency skills (name, description, and goal) and agreed they would be helpful to them. 
They also noted interest in learning about: survivorship plans, adaptation to deficits 
(present or anticipated), and return to normal living. This led to the development and 
subsequent refinement (through feedback from the nursing team) of the Recovering 
Together Program active intervention.  
 
3) Is the effect of the skills-based intervention for pts and cgs in the ICU durable? 
  
We will assess feasibility, usability, and acceptability by the enrollment numbers, 
participants completion in at least 4 out of 6 sessions, and the questionnaires, The 
Credibility and Expectancy and Client Satisfaction Scale. These will be primary 
outcomes. The PCL-S, HADS, and resiliency measures will serve as the secondary 
outcomes.  
 
We will use student’s t-test to assess within-group differences in long-term outcomes. We 
will compare measures at the 3 month follow-up assessment to measures at the post-
intervention assessment for both study arms.  
 
We will also use t tests and chi squared tests to assess differences at the 3 month follow 
up.  
 
 
VII. RISKS AND DISCOMFORTS 

 
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There is a risk that some participants may feel uncomfortable completing various psychological 
questionnaires or parts of the skills-based on intervention. Participants are free to withdraw from 
the study at any time, as the study is completely voluntary.  
 
As in any research study, there is a small risk that confidentiality may be breached; all efforts to 
minimize this risk will be taken. In the unlikely event that participants will become suicidal 
during the duration of the study, the research assistant will contact the PI and the appropriate 
clinical intervention will be executed.  
 
 
VIII. POTENTIAL BENEFITS 
 
Participants in this study may observe a reduction in depression, anxiety, and/or psychological 
and physiological markers of stress, as well as an improvement in perceived qualify of life. It is 
hoped that the intervention will result in improvements across these domains. Participants may 
learn new techniques for managing distress and lifestyle factors that may enhance wellbeing, 
both in disease-specific domains as well as in their general lives. In addition, all participants will 
receive $20 for the completion of each of the 3 assessment points. 
 
IX. MONITORING AND QUALITY ASSURANCE 
 
Electronic information will be stored in REDCap (Research Electronic Data Capture), a free, 
secure, and HIPAA-compliant web-based application hosted by the Partners HealthCare 
Research Computing Enterprise Research Infrastructure & Services (ERIS) group (based at the 
PHS Needham corporate datacenter). Data will be stored on password protected computers that 
will be stored in secure locations at all times. Paper data files (with coded subject identification) 
will be stored in a locked filing cabinet. Only research staff will have access to these data 
locations.  
 
A unique anonymous identifier will be assigned to each subject; subsequently, all data collected 
will be associated exclusively with this identifier. This includes all questionnaires administered 
over the course of the study, as well as home practice logs. 
 
Data from this study will be stored for three years after the publication of all study results, at 
which time all paper data files will be shredded, and computer files will be deleted.  
 
Data Management and Quality Control Procedures 
 
To maximize accuracy and security, all survey data will be collected and stored on REDCap. 
Research staff will ensure that proper consent has been obtained before sending the REDCap 
survey to each participant.  
 
REDCap (Research Electronic Data Capture) is a free, secure, HIPAA compliant web-based 
application hosted by the Partners HealthCare Research Computing Enterprise Research 
Infrastructure & Services (ERIS) group. Vanderbilt University, with collaboration from a 

 
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consortium of academic and non-profit institutional partners, has developed this software toolset 
and workflow methodology for electronic collection and management of research and clinical 
study data. Data collection projects rely on a study-specific data dictionary defined by members 
of the research team with planning assistance from Harvard Catalyst, The Harvard Clinical and 
Translational Science Center EDC Support Staff. This iterative development and testing process 
results in a well-planned data collection strategy for individual studies. Using REDCap, the 
research team can also design web-based surveys and engage potential respondents using a 
variety of notification methods. REDCap provides flexible features that can be used for a variety 
of research projects and provides an intuitive interface to enter data with real time validation 
(automated data type and range checks). The system offers easy data manipulation with audit 
trails, reports for monitoring and querying participant records, and an automated export 
mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus).  
 
Since consistency of application of the study protocol is critical to acquiring high quality data, all 
research personnel have undergone or will undergo a competency-based training program prior 
to enrolling subjects. 
 
Data and Safety Monitoring Plan 
 
Adverse Event Monitoring: Throughout the study subjects will be monitored for the occurrence 
of events defined as any undesirable experience or unanticipated risk. Lack of effect of treatment 
is not considered an event. All adverse events will be reported on an adverse event form. The 
Principle Investigator has the responsibility of reporting serious adverse events (death, life 
threatening illness or injury, serious injury, or permanent disability) to PHRC within 24-72 hours 
of notification. 
 
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