Clinical trial NCT03826875
Conditions: Stroke Hemorrhagic Depression
Keywords: stroke hemorrhagic stroke subarachnoid hemorrhage depression
Sponsor: University of Washington
Start date: 2019-03-01; Completion date: 2025-05-07
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.

Detailed description:
Patients who suffered aneurysmal subarachnoid hemorrhage will be randomly assigned either an oral antidepressant or placebo and evaluated for the preventative treatment of depression and health-related quality-of-life.

Arms: arm 1: Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year. arm 2: Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.
Interventions: intervention 1: Fluoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed fluoxetine and evaluated for the preventative treatment of depression and health-related quality-of-life intervention 2: Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed placebo and evaluated for the preventative treatment of depression and health-related quality-of-life

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
Preventative treatment of depression in survivors of aneurysmal subarachnoid 
hemorrhage 
 
Abbreviated Title: Depression in aSAH 
 
Protocol Number: IRB# STUDY00002718 
 
 
Amendment Date: March 4, 2024 
 
 
Sponsor: 
University of Washington 
Harborview Medical Center 
325 9th Ave  
Seattle, WA 98104 
 
 
Study Principal Investigator: Michael Levitt MD 
 
 
 
 
 


 
Administrative information 
Title 
Preventative treatment of depression in survivors of 
aneurysmal subarachnoid hemorrhage 
Trial registration 
NCT03826875 
Protocol version 
March 4, 2024 
Funding 
Brain Aneurysm Foundation 
Author details 
Michale Levitt MD, Louis Kim MD, Cory Kelly, Keiko 
Prijoles, Do Lim 
Name and contact information 
for the trial sponsor 
Michael Levitt MD (PI) 
University of Washington  
Harborview Medical Center 
325 9th Ave   
Seattle, WA 98104 
 
206-744-9330 
Role of sponsor 
Study design; collection, management, analysis, 
and interpretation of data; writing of the report; and 
the decision to submit the report for publication 
 
 


 
Introduction 
Background and rationale 
Approximately 30,000-50,000 patients suffer from SAH every year in North America, 
and it accounts for 5% of all strokes in the USA. The grave nature of this disease results 
in an approximately 35-50% mortality rate. As medical technology and techniques have 
improved, more and more of these patients are surviving this devastating neurological 
injury. However, the increasing number of survivors faces many challenges in their 
recovery and return to a normal life.  
 
A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain is 
either blocked by a clot or bursts (or ruptures). When that happens, part of the brain 
cannot get the blood (and oxygen) it needs, so it and brain cells die. Stroke can be 
caused either by a clot obstructing the flow of blood to the brain (called an ischemic 
stroke) or by a blood vessel rupturing and preventing blood flow to the brain (called a 
hemorrhagic stroke). There are two types of hemorrhagic stroke: intracerebral 
hemorrhage (ICH) and subarachnoid hemorrhage (SAH).  ICH stroke happens when a 
blood vessel inside the brain bursts and leaks blood into surrounding brain tissue. The 
bleeding causes brain cells to die and the affected part of the brain stops working 
correctly. SAH stroke involves bleeding in the area between the brain and the tissue 
covering the brain, known as the subarachnoid space. SAH stroke can be caused by 
malformation of the blood vessels, bleeding disorders, blood thinners, or most 
commonly by burst aneurysms. This type of stroke is called aneurysmal subarachnoid 
hemorrhage or aSAH.  
 
Survivors of SAH often suffer from new depression disorders after recovery, resulting in 
a decreased quality of life and increased health care costs. Approximately 1/3 of all 
SAH patients without a previous history of mood disorder have signs or symptoms of 
depression at least one year after hospitalization. Multiple studies of patients who 
become depressed after any type of significant injury show that their treatment is at 
least twice the cost of patients who do not develop depression. This cost rises 
substantially with both age and depression severity. 


 
 
Our goal with this study is twofold; first, to address the gap in knowledge of utility of 
prophylactic SSRI in the aSAH subpopulation of stroke patients, and second, to study 
the role of cortisol regulation in susceptibility to depression so that we might identify 
what patients would most benefit from SSRI prophylaxis. We hypothesize that placing 
aSAH patients on preventative anti-depressant medications at the time of stroke may 
both improve their lives and the lives of their families, while also decreasing post-injury 
health care costs. 
 
Fluoxetine (an antidepressant commonly known as Prozac) is among a group of 
medications known as selective-serotonin reuptake inhibitors that work to maintain 
higher-than-normal levels of serotonin, a neurotransmitter popularly associated with 
contributions to well-being and happiness. Fluoxetine is a World Health Organization 
Essential Medicine and is considered a first-line treatment for depression by the 
American Psychiatric Association. In addition, fluoxetine has a fast treatment effects 
and is inexpensive. It is currently not standard to implement antidepressant medications 
after aneurysm rupture due to the lack of studies on their preventative benefits to aSAH 
patients. 
 
The use of SSRIs has been studied in the general poststroke population, to include 
patients with aSAH. However, the aSAH population has not been evaluated as an 
independent experimental cohort.  These studies demonstrated no difference in adverse 
events between the stroke population and general population. Furthermore, one arm of 
the ongoing poststroke depression triad trials (AFFINITY, FOCUS, and EFFECT) is also 
including aSAH patients, but again not looking at these patients as an independent 
experimental cohort. Meta-analyses have demonstrated “Poststroke depression has 
been shown in 6 double-blind controlled studies to be effectively treated with 
antidepressants, and 1 study has recently shown that PSD can be effectively prevented” 
(Robinson 2010). More granular studies evaluating SSRIs and hemorrhagic stroke also 
demonstrated adverse events to be no more frequent than controls as well as similar 
medical outcomes. Furthermore, in our current clinical practice, aSAH patients currently 


 
on SSRIs at presentation are either continued on their SSRIs or restarted on their 
SSRIs following treatment, without increased clinical concern. 
 
This trial will evaluate the effect of preventative treatment of depression in survivors of 
aSAH patients to development of depression. Eligible patients will be divided into three 
groups: a control group, which receives a placebo medication, and an intervention 
group, which will receive fluoxetine, Patients will be evaluated for depression and health 
care-related quality of life immediately after treatment of aSAH, and several times over 
the first year of recovery. We expect that the patients receiving antidepressant 
medications will show an improvement in depression incidence, depression severity, 
and quality of life when compared to those patients who receive a placebo. We 
anticipate that these patients will have reduced post-injury health care utilization costs 
and return to work more often than those receiving placebo. The control group that 
receives a placebo is necessary to prove that the difference between the two groups is 
based on the effects of fluoxetine, rather than a placebo effect.  
 
Objectives 
We propose a double-blinded placebo-controlled randomized trial to evaluate the effect 
of preventative treatment of depression in survivors of aneurysmal subarachnoid 
hemorrhage (aSAH), a type of stroke. 
 
Trial design 
This investigation is pragmatic, prospective, double-blinded, placebo-controlled 
randomized trial to evaluate the effect of preventative treatment of depression in 
survivors of aneurysmal SAH, a type of non-traumatic, hemorrhagic stroke. Over a one-
year period, English speaking adults (18-85 years old) of all genders admitted to, 
treated at, and discharging from Harborview Medical Center for aneurysmal SAH will be 
randomly prescribed either an oral antidepressant (the SSRI fluoxetine, commonly 
known as Prozac) or placebo prior to discharge. The control group that receives a 
placebo is necessary to prove that the difference between the two groups is based on 
the effects of the antidepressant medication, rather than a placebo effect. Patients will 


 
be evaluated for depression and health-related quality of life immediately after treatment 
of SAH over the course of a one year following discharge. Patients declining the 
randomized trial, will be recruited into an observational cohort to establish baseline 
rates of symptoms. 
 
Methods: Participants, interventions and outcomes 
Study setting 
The University of Washington School of Medicine’s Harborview Medical Center is the 
primary tertiary referral center for the Pacific Northwest and WWAMI region and a 
Certified Comprehensive Stroke Center, per the Joint Commission and American Heart 
Association/American Stroke Association. Each year over 200 patients are admitted to 
Harborview Medical Center for aneurysmal SAH. Harborview Medical Center maintains 
an Investigational Drug Service that manages medications used in clinical trials.   
 
Eligibility criteria 
1) Patients 18 years of age and older will be included. 
2) Patients above 85 years of age will be excluded from the drug vs placebo cohort. 
3) Patients admitted for subarachnoid hemorrhage from a ruptured cerebral 
aneurysm will be included.  
4) Non-English speaking patients will be excluded. 
5) Patients currently receiving therapy for depression or related mental health 
diagnoses before admission will be excluded. 
6) Patients with medical contraindications to fluoxetine therapy will be excluded 
from the drug vs placebo arms 
7) Pregnant patients or patients considering pregnancy during the trial period at the 
time of consent will be excluded from the drug vs placebo arms. 
8) Patients with active psychosis will be excluded.  
9) Patients who are incarcerated or in police custody will be excluded. 
10) Patients with a comorbidity or cognitive impairment (as determined by a recruiter-
administered Montreal Cognitive Assessment [MoCA]; Patients scoring >20 are 
considered of appropriate cognitive function for consent) that precludes informed 


 
consent and participation in the research interviews will be excluded from the 
observational and drug vs placebo cohorts, but may be included in the biofluid 
cohort. 
 
Who will take informed consent? 
Potential patient-subjects will be identified by neurosurgeons on the treatment team. 
Patients will be recruited and screened for participation in the drug vs placebo or 
observational cohort by a member of the research team prior to discharge. Patient 
inclusion and exclusion will be determined by the medical record as well as in-person by 
the provider. The Montreal Cognitive Assessment will be administered prior to the 
consent to determine baseline cognitive state. We will also conduct screening to 
determine if the patient is currently receiving therapy for depression or related mental 
health diagnoses. Any recruiter who administers the MoCA completes MoCA training 
and certification. Patients scoring >20 on the MoCA are considered of appropriate 
cognitive function to participate in the study. 
 
Patients recruited for the drug vs placebo cohort will be provided with a detailed 
explanation regarding the study protocol, occurrence of depression in aneurysmal 
subarachnoid hemorrhage and the potential treatment effects of fluoxetine. Patients will 
have an opportunity for questions before providing before consent. Decisional capacity 
will be determined by having participants confirm their understanding of the study 
purpose and procedure, and the risks, benefits and alternatives to participating in the 
study. 
 
Interventions 
Explanation for the choice of comparators 
If a patient chooses to decline treatment with fluoxetine but is eligible for the 
observational cohort, they will be given the necessary study information. Patients can 
choose to provide consent anytime between approach and discharge. Patients may 
revoke their informed consent at any time by contacting the research team. 
 


 
Intervention description  
Patients deemed eligible for inclusion in the drugs vs. placebo or observational cohort 
will be approached for consent in the inpatient ward as they are nearing discharge after 
aSAH. After consent is obtained, patients will be randomized to either a placebo or 
fluoxetine-treatment group. Patients that decline participation in the drug vs placebo arm 
may be enrolled in the observational cohort.  
 
For patients participating in the drug vs. placebo cohort, the study drug will be provided 
at no cost for the duration of the trial (1 year).  
 
Patients randomized to the fluoxetine treatment group will be initially prescribed 
fluoxetine 20mg/day. The drug will be supplied to patients in 90-day supply. For patients 
in the drug/placebo cohort, if severe depression (as defined by a HAM-D score of >24 or 
a PHQ-9 score >20 or positive endorsement on the PHQ-9 suicide items 2 or 3) is 
persistent at any study time points, an additional fluoxetine dose of 20mg/day will be 
administered for 40mg total dose for fluoxetine group. 
 
If severe depression is persistent at any study time points for patients randomized to the 
placebo group (as defined above), they will be prescribed 20 mg of fluoxetine.  
 
The research assistant will administer an approximately 45-minute interview at up to five 
time points to all patient-subjects: upon enrollment (prior to hospital discharge) as a 
baseline assessment, and up to four follow-up visits within 18 months after discharge 
from the hospital.  
 
The goal will be to do these assessments at the six-week, six-month, and one-year 
follow-up appointments, taking into consideration that the actual appointments 
frequently do not occur exactly on the intended timescale. The trial period will be for 12 
months after discharge; however, should we need to speak with patients or if they miss 
their 12 month appointment, we will allow for another timepoint within 18 months.  
 


 
The interview questionnaires will assess depression and health-related quality of life, 
medication compliance, drug side effects and pregnancy, either in person, over the 
phone, via email, or mail. If the participant endorses serious side effects, the event will 
immediately be reported to and reviewed by the study PI for its relatedness to the study 
and it will be reported to IRB in accordance with University of Washington IRB 
reportable event guidelines. 
 
Depression will be assessed using the Hamilton Rating Scale for Depression (HAM-D) 
and the Patient Health Questionnaire (PHQ-9). Health-related quality of life will be 
assessed using the Medical Outcomes Short Form Health Survey (SF-36). All measures 
will be assessed at each time point.  
 
For patients reaching the end of the study and choosing to discontinue the study drug, 
the two week weaning period will begin at the completion of the 12-month trial period. 
Patient education regarding continuation or discontinuation of SSRI treatment at the 
completion of the study will be provided 90 days prior to reaching the end of the study, 
regardless of treatment group. From time to time, members of the study team may 
contact the patient to ensure medication compliance and answer questions about 
medications and the study the subject may have. 
 
If any patient, in the drug vs. placebo demonstrates severe depression (as defined by a 
HAM-D score of >24 or a PHQ-9 score >20 or positive endorsement on the PHQ-9 
suicide items 2 or 3) is persistent at any study time points, patient will be immediately 
directed to their physician for further evaluation. If a patient endorses suicidal ideation, 
they will be immediately referred to the psychiatric service for further urgent mental 
health evaluation before a dosage increase is considered. If a patient is removed from 
the study, that data will be included in the subsequent data analysis.   
 
After a final timepoint at approximately 1 year after hospitalization (but up to 18 
months), the subjects’ study enrollment will be complete. 
 


 
Criteria for discontinuing or modifying allocated interventions 
Patients may be withdrawn from the research without their consent if the patient is no 
longer able to participate in the research protocol. In any case that a patient-subject will 
be discontinuing the drug, we will taper over two weeks, halving the dose each week. 
 
Outcome Measures 
• For all subjects enrolled in the study, relevant clinical and demographic data, 
including PHI such as name, date of birth, dates related to hospital stay, 
medications, and medical record number.   
• Montreal Cognitive Assessment (MoCA)- 30-item questionnaire to determine 
cognitive status.  
• Patient Health Questionnaire 9 (PHQ9): 9-item questionnaire to treat and 
diagnosis depression.  
• Hamilton Rating Scale for Depression (HAM-D: 30-item questionnaire to treat 
and diagnosis depression. This will be given if a patient exhibits depression 
based on the PHQ9 score.   
• The Short Form (36) Health Survey (SF-36): 36-item questionnaire to assess 
health-related quality-of-life.  
• Barthel Index: Scale used to determine functional status, measuring performance 
in activities of daily living.   
• Hamilton Anxiety Rating Scale: Measures the severity of anxiety through looking 
at both psychic and somatic anxiety.   
• Multidimensional Scale of Perceived Social Support: Scale to determine a 
patients social support system  
• PROMIS: Sleep disturbance scale assess pure domain of sleep disturbance  
• Health Care Utilization: Assess ER visits, outpatient visits, rehospitalization and 
mortality  
• Fatigue Severity Scale: Measures the severity of fatigue and its effect on a 
person’s activities and lifestyle in patients exhibiting depression   
 
Participant timeline  


 
 
The research assistant will administer an approximately 45-minute interview at up to five 
time points to all patient-subjects: upon enrollment (prior to hospital discharge) as a 
baseline assessment, and at up to four follow-up visits within 18 months after discharge 
from the hospital.  
 
The goal will be to do these assessments at the six-week, six-month, and one-year 
follow-up appointments, taking into consideration that the actual appointments 
frequently do not occur exactly on the intended timescale. The trial period will be for 12 
months after discharge; however, should we need to speak with patients or if they miss 
their 12 month appointment, we will allow for another timepoint within 18 months. 
 
For patients reaching the end of the study and choosing to discontinue the study drug, 
the two week weaning period will begin at the completion of the 12-month trial period. 
Patient education regarding continuation or discontinuation of SSRI treatment at the 
completion of the study will be provided 90 days prior to reaching the end of the study, 
regardless of treatment group. From time to time, members of the study team may 
contact the patient to ensure medication compliance and answer questions about 
medications and the study the subject may have. 
 
Sample size  
Based upon previous studies we anticipate the rate of depression in the treatment group 
to be 7.3% and the rate of depression in the placebo group to be 21.2%, as determined 
by the HAM-D score. It is estimated that 200 patients are eligible per year, however we 
have conservatively estimated enrolling 20 patients to account for recruitment and 
retention rates. Power calculations show a large-scale trial would require 224 total 
patients. We anticipate analysis at 1-year (as funded from this proposal) will 
demonstrate the feasibility of both the randomized administration of antidepressant 
medication to the post-SAH population, as well as prospectively define the rate of new 
depression and the effect of SAH on health-related quality of life. 
 


 
Recruitment  
Patients will be recruited and screened for participation by a member of the research 
team prior to discharge. Patient inclusion and exclusion will be determined by the 
medical record as well as in-person by the provider. The Montreal Cognitive 
Assessment will be administered prior to the consent to determine baseline cognitive 
state. We will also conduct screening to determine if the patient is currently recieveing 
therapy for depression or related mental health diagnoses. Any recruiter who 
administers the MoCA completes MoCA training and certification. Patients scoring >20 
on the MoCA are considered of appropriate cognitive function to participate in the study.  
  
Patients recruited for the drug vs placebo cohort will be provided with a detailed 
explanation regarding the study protocol, occurrence of depression in aneurysmal 
subarachnoid hemorrhage and the potential treatment effects of fluoxetine. Patients will 
have an opportunity for questions befor providing before consent. Decisional capacity 
will be determined by having participants confirm their understanding of the study 
purpose and procedure, and the risks, benefits and alternatives to participating in the 
study.  
  
Relevant clinical and demographic data such as name, date of birth, dates related to 
hospital stay, medical record number, area of the ruptured aneurysm, Glasgow Coma 
Score, Fisher Grade, Hunt and Hess Grade, Medications, medical history, and 
comorbidity which will be maintained in a secure screening and recruitment log. Patients 
can choose to provide consent anytime between approach and discharge. Patients may 
revoke their informed consent at any time by contacting the research team. 
 
 
Assignment of interventions: allocation 
Sequence generation  
Simple randomization schemes will be utilized for the drug cohort and placebo cohort. 
For each cohort, subjects will be randomized in a 1 to 1 ratio to receive either the SSRI 
antidepressant or placebo drugs. Randomization will be done after the participant or 


 
LAR as signed the ICF. Randomization will be performed by the study pharmacist. 
Study team, study assessor, study investigator is blinded until the subject exits the 
study, need to unblind for medical intervention, or end of the study.  
 
 
Assignment of interventions: Blinding 
Who will be blinded 
Trial participants, care providers, outcome assessors will stay blinded. Placebo vs study 
drug will be prepared and dispensed by local study pharmacist. Only the study 
pharmacy will know the designation of each participant until the clinical team request 
the information for health care purposes or when the participants exit the study.  
 
Procedure for unblinding if needed 
If an adverse event occurs in which the disclosure of the treatment arm is necessary for 
medical treatment, the disclosure will be provided to the patient and/or provider.   
 
Data collection and management 
Plans for assessment and collection of outcomes 
Preventative treatment of poststroke depression in aneurysmal subarachnoid hemorrhage  
Activity 
Initial Screening Baseline 6-week 6-month 12-month 
Eligiblility Screen  
x 
 
 
 
 
Montreal Cognitive 
Assessment (MoCA)* 
x 
 
 
 
 
Enrollment  
x 
 
 
 
 
Consent  
x 
 
 
 
 
OnCore/EPIC  Update 
x 
x 
x 
x 
x 
Pharmacy Prescription 
Fluoxetine (every 90 days)  
 
x 
x 
x 
 
Patient Health Questionnaire 
(PHQ-9) 
 
x 
x 
x 
x 


 
Hamilton Rating Scale for 
Depression (HAM-D)** 
 
x 
x 
x 
x 
36-Item Short Form Survey 
(SF-36)  
 
x 
x 
x 
x 
Barthel Index 
 
x 
x 
x 
x 
Hamilton Anxiety Rating 
Scale (HAM-A) 
 
x 
x 
x 
x 
Multidimensional Scale of 
Perceived Social Support  
 
x 
x 
x 
x 
Sleep Distrubance (PROMIS)  
x 
x 
x 
x 
Self Report Health Service 
Utilization and Medication 
Use  
 
x 
x 
x 
x 
Fatigue Severity Scale (FSS)  
x 
x 
x 
x 
Disclosure of Interventional 
Cohort  
 
 
 
 
x 
*MoCA score must score more than 20 in order to be enrolled and consented into the study 
**HAM-D only conducted when pt scores greater than 4 on PHQ-9 
 
 
Confidentiality and Data management  
All research data will be deidentified. A single-master key will be retained. All data will 
be stored on a secure research database or in a secure cabinet on a secure floor. 
Access to identifiers will be limited to the study team. Data will be classified as Level 4 
risk. U1-U13, D1-D9 will apply to all data. S1-S20 will be utilized; local procedures will 
be utilized in addition to the protections afforded by utilizing the UW OneDrive. P1-P3 
will be utilized for non-digital records. T1-T8 will be utilized for data transmission. We do 
not intend to utilize vendors, but if vendors are utilized we will adhere to V1. 
 
Statistical methods 
Statistical methods for primary and secondary outcomes  
In addition to patient-level measures, relevant clinical and demographic data will be 


 
obtained for the descriptive statistics of the cohort. For each time point we will 
determine the rate and severity of the outcome measures. We will utilize linear mixed 
models to determine to determine the treatment effect of preventative fluoxetine 
administration in patients surviving subarachnoid hemorrhage. Important confounders 
will be determined and adjusted for in the analysis. The primary outcome will be 
analyzed at the one-year time point. The intermediate time points will be obtained to 
determine the longitudinal progression of the mental health status and functional ability 
in this patient population. 
 
Oversight and monitoring 
Composition of the coordinating centre and trial steering committee 
The PI (or approved co-investigator) will monitor the study with prompt reporting of 
adverse events and other study related information to the IRB and other agencies as 
appropriate. Non-serious adverse events and unrelated serious adverse events will be 
reported in the annual progress report. Serious adverse events that could be related to 
the study should be reported within 7 days of becoming aware of the event. At any time, 
if a patient presents suicidal ideations, the patient will be immediately referred to 
psychiatric service for further evaluation and the event reported. Team meetings by the 
PI and staff will be conducted on a routine basis to discuss any new adverse events or 
changes in the protocol. This plan will be revised and updated if the benefit-risk analysis 
changes. 
 
Composition of the data monitoring committee, its role and reporting structure 
An independent medical monitor, an appropriately qualified physician with no conflict of 
interest and meeting he NINDS recommendation of being otherwise unaffiliated with the 
study or an institution conducting the study, will perform safety-focused reviews 
considering adverse events at a minimum of 6 month intervals. 
 
Adverse event reporting and harms 
The PI (or approved co-investigator) will monitor the study with prompt reporting of 
adverse events and other study related information to the IRB and other agencies as 


 
appropriate. Non-serious adverse events and unrelated serious adverse events will be 
reported in the annual progress report. Serious adverse events that could be related to 
the study should be reported within 7 days of becoming aware of the event. At any time, 
if a patient presents suicidal ideations, the patient will be immediately referred to 
psychiatric service for further evaluation and the event reported. 
 
If an adverse event occurs in which the disclosure of the treatment arm is necessary for 
medical treatment, the disclosure will be provided to the patient and/or provider. 
 
 
Frequency and plans for auditing trial conduct 
Internal audit will be conducted routinely with study PI and the study team. An 
independent medical monitor, an appropriately qualified physician with no conflict of 
interest and meeting the NINDS recommendation of being otherwise unaffiliated with 
the study or an institution conducting the study, will perform safety-focused reviews 
considering adverse events at a minimum of 6 month intervals. 
 
Plans for communicating important protocol amendments to relevant parties (e.g. 
trial participants, ethical committees) 
Team meetings by the PI and staff will be conducted on a routine basis to discuss any 
new adverse events or changes in the protocol. This plan will be revised and updated if 
the benefit-risk analysis changes. 
 
Dissemination plans 
A description of this clinical trial will be available on https://clinicaltrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, 
the Web site will include a summary of the results. You can search this Web site at any 
time. 
 
 


 
Patient Health Questionnaire Depression (PHQ-9) (Kroenke et al., 2001) 
 
 
For this next section, the questions I’ll be asking you will be in regards to your mood in 
the past month, since your injury. 
 
 
Phq 
 
Since your injury, how often have you been bothered 
by any of the following problems? 
Not at 
all 
A little of 
the time 
More than 
half the 
time 
Nearly all 
the time 
1. 
Little interest or pleasure in doing things 
0 
1 
2 
3 
2. 
Feeling down, depressed or hopeless 
0 
1 
2 
3 
3. 
Trouble falling or staying asleep, or sleeping too much 
0 
1 
2 
3 
4. 
Feeling tired or having little energy 
0 
1 
2 
3 
5. 
Poor appetite or overeating 
0 
1 
2 
3 
6. 
Feeling bad about yourself- or that you are a failure or 
have let yourself or your family down 
0 
1 
2 
3 
7. 
Trouble concentrating on things, such as reading the 
newspaper or watching television 
0 
1 
2 
3 
8. 
Moving or speaking so slowly that other people could 
have noticed? Or the opposite - being so fidgety or 
restless that you have been moving around a lot more 
than usual 
0 
1 
2 
3 
9. 
Thoughts that you would be better off dead or of 
hurting yourself in some way. 
 
*Note, if any endorsement, RA assess further and 
contact PI  
[9a.] Do you currently have plans to harm 
 
yourself or take your own life? Yes 
No 
 
if no, proceed to next section 
 
[9b.] Have you attempted to carry out this 
 
plan in the past two weeks? 
Yes 
No 
0 
1 
2 
3 
10. 
[If YES to any problems] How difficult have these 
problems made it for you to do your work, take care of 
things at home, or get along with other people? 
0 
Not at 
all 
1 
A little bit 
2 
Moderately 
3 
Extremely 
 
Total Score: _______ 


 
The Hamilton Rating Scale for Depression 
 
 
1. DEPRESSED MOOD (Sadness, hopeless, helpless, worthless) 
 
0= Absent 
 
1= These feeling states indicated only on questioning  
2= These feeling states spontaneously reported verbally 
3= Communicates feeling states non-verbally—i.e.,through facial expression, posture, 
voice, and tendency to weep 
4= Patient reports VIRTUALLY ONLY these feeling states in his spontaneous verbal and non-
verbal communication 
 
2. FEELINGS OF GUILT 
 
0= Absent 
 
1= Self reproach, feels he has let people down 
 
2= Ideas of guilt or rumination over past errors or sinful deeds  
 
3= Present illness is a punishment. Delusions of guilt 
 
4= Hears accusatory or denunciatory voices and/or experiences threatening visual 
hallucinations 
 
3. SUICIDE 
 
0= Absent 
 
1= Feels life is not worth living 
 
2= Wishes he were dead or any thoughts of possible death to self  
 
3= Suicidal ideas or gesture 
 
4= Attempts at suicide (any serious attempt rates 4) 
 
4. INSOMNIA EARLY 
 
0= No difficulty falling asleep 
 
1= Complains of occasional difficulty falling asleep—i.e., more than 1/2 hour  
 
2= Complains of nightly difficulty falling asleep 
 
5. INSOMNIA MIDDLE 
 
0= No difficulty 
 
1= Patient complains of being restless and disturbed during the night 
 
2= Waking during the night—any getting out of bed rates 2 (except for purposes of 
voiding) 
 
6. INSOMNIA LATE 
 
0= No difficulty 
 
1= Waking in early hours of the morning but goes back to sleep  
 
2= Unable to fall asleep again if he gets out of bed 
 
7. WORK AND ACTIVITIES 
 
0= No difficulty 
 
1= Thoughts and feelings of incapacity, fatigue or weakness related to activities; work or 
hobbies 
 


 
2= Loss of interest in activity; hobbies or work—either directly reported by patient, or 
indirect in listlessness, indecision and vacillation (feels he has to push self to work or 
activities) 
 
3= Decrease in actual time spent in activities or decrease in productivity  
 
4= Stopped working because of present illness 
 
 


 
8. RETARDATION: PSYCHOMOTOR (Slowness of thought and speech; impaired ability to 
concentrate; decreased motor activity) 
 
0= Normal speech and thought  
1= Slight retardation at interview  
2= Obvious retardation at interview 
3= Interview difficult 
 
4= Complete stupor 
 
9. AGITATION 
 
0= None 
 
1= Fidgetiness 
 
2= Playing with hands, hair, etc.  
 
3= Moving about, can’t sit still 
 
4= Hand wringing, nail biting, hair-pulling, biting of lips 
 
10. ANXIETY (PSYCHOLOGICAL) 
 
0= No difficulty 
 
1= Subjective tension and irritability  
 
2= Worrying about minor matters 
 
3= Apprehensive attitude apparent in face or speech  
 
4= Fears expressed without questioning 
 
11. ANXIETY SOMATIC: Physiological concomitants of anxiety, (i.e., effects of autonomic 
overactivity, “butterflies,” indigestion, stomach cramps, belching, diarrhea, palpitations, 
hyperventilation, paresthesia, sweating, flushing, tremor, headache, urinary frequency). Avoid 
asking about possible medication side effects (i.e., dry mouth, constipation) 
 
0= Absent  
 
1= Mild 
 
2= Moderate  
 
3= Severe 
 
4= Incapacitating 
 
12. SOMATIC SYMPTOMS (GASTROINTESTINAL) 
 
0= None 
 
1= Loss of appetite but eating without encouragement from others. Food intake about 
normal 
 
2= Difficulty eating without urging from others. Marked reduction of appetite and food 
intake 
 
13. SOMATIC SYMPTOMS GENERAL 
 
0= None 
 
1= Heaviness in limbs, back or head. Backaches, headache, muscle aches. Loss of 
energy and fatigability 
 
2= Any clear-cut symptom rates 2 
 


 
14. GENITAL SYMPTOMS (Symptoms such as: loss of libido; impaired sexual performance; 
menstrual disturbances) 
 
0= Absent  
 
1= Mild  
 
2= Severe 
 
15. HYPOCHONDRIASIS 
 
0= Not present 
 
1= Self-absorption (bodily)  
2= Preoccupation with health 
 
3= Frequent complaints, requests for help, etc. 
4= Hypochondriacal delusions 
 
16. LOSS OF WEIGHT 
 
A. When rating by history:  
0= No weight loss 
 
1= Probably weight loss associated with present illness  
2= Definite (according to patient) weight loss 
 
3= Not assessed 
 
17. INSIGHT 
 
0= Acknowledges being depressed and ill 
 
1= Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need 
for rest, etc. 
2= Denies being ill at all 
 
18. DIURNAL VARIATION 
 
A. Note whether symptoms are worse in morning or evening. If NO diurnal variation, mark 
none  
0= No variation 
 
1= Worse in A.M.  
2= Worse in P.M. 
 
B. When present, mark the severity of the variation. Mark “None” if NO variation 
 
0= None 
 
1= Mild 
 
2= Severe 
 
19. DEPERSONALIZATION AND DEREALIZATION (Such as: Feelings of unreality; Nihilistic 
ideas) 
 
0= Absent  
1= Mild 
 
2= Moderate  
3= Severe 
 
4= Incapacitating 
 
20. PARANOID SYMPTOMS 
 
0= None 
 
1= Suspicious 
 
2= Ideas of reference 
 


 
3= Delusions of reference and persecution 
 
21. OBSESSIONAL AND COMPULSIVE SYMPTOMS 
 
0= Absent  
1= Mild  
2= Severe 
  
Total Score: _______ 
 


 
 
36-Item Short Form Survey Instrument (SF-36) 
 
1. In general, would you say your health is: 
1= Excellent 
2= Very good 
3= Good 
4= Fair 
5= Poor 
 
2. Compared to one year ago, how would you rate your health in general now? 
1= Much better now than one year ago 
2= Somewhat better now than one year ago 
3= About the same 
4= Somewhat worse now than one year ago 
5=  Much worse now than one year ago 
 
The following items are about activities you might do during a typical day. Does your health now limit 
you in these activities? If so, how much? 
 
Yes, 
limited 
a lot 
Yes, 
limited a 
little 
No, not 
limited 
at all 
3. Vigorous activities, such as running, lifting heavy objects, participating 
in strenuous sports 
1 
2 
3 
4. Moderate activities, such as moving a table, pushing a vacuum 
cleaner, bowling, or playing golf 
1 
2 
3 
5. Lifting or carrying groceries 
1 
2 
3 
6. Climbing several flights of stairs 
1 
2 
3 
7. Climbing one flight of stairs 
1 
2 
3 
8. Bending, kneeling, or stooping 
1 
2 
3 
9. Walking more than a mile 
1 
2 
3 
10. Walking several blocks 
1 
2 
3 
11. Walking one block 
1 
2 
3 
12. Bathing or dressing yourself 
1 
2 
3 
 
 


 
 
 
 
During the past 4 weeks, have you had any of the following problems with your work or other regular daily 
activities as a result of your physical health? 
 
Yes 
No 
13. Cut down the amount of time you spent on work or other activities 
1 
2 
14. Accomplished less than you would like 
1 
2 
15. Were limited in the kind of work or other activities 
1 
2 
16. Had difficulty performing the work or other activities (for example, it took 
extra effort) 
1 
2 
 
 
During the past 4 weeks, have you had any of the following problems with your work or other regular daily 
activities as a result of any emotional problems (such as feeling depressed or anxious)? 
 
Yes 
No 
17. Cut down the amount of time you spent on work or other activities 
1 
2 
18. Accomplished less than you would like 
1 
2 
19. Didn't do work or other activities as carefully as usual 
1 
2 
 
 
20. During the past 4 weeks, to what extent has your physical health or emotional problems interfered 
with your normal social activities with family, friends, neighbors, or groups? 
1= Not at all 
2= Slightly 
3= Moderately 
4= Quite a bit 
5= Extremely 
 
21.  How much bodily pain have you had during the past 4 weeks? 
1= None 
2= Very mild 
3= Mild 
4= Moderate 
5= Severe 
6= Very severe 
  
22. During the past 4 weeks, how much did pain interfere with your normal work (including both 
work outside the home and housework)? 
1= Not at all 
2= A little bit 
3= Moderately 
4= Quite a bit 
5= Extremely 


 
 
These questions are about how you feel and how things have been with you during the past 4 weeks. For each 
question, please give the one answer that comes closest to the way you have been feeling. 
 
How much of the time during the past 4 weeks... 
 
 
All of 
the 
time 
Most 
of the 
time 
A 
good 
bit of 
the 
time 
Some 
of the 
time 
A little 
of the 
time 
None 
of the 
time 
23. Did you feel full of pep? 
1 
2 
3 
4 
5 
6 
24. Have you been a very nervous person? 
1 
2 
3 
4 
5 
6 
25. Have you felt so down in the dumps that 
nothing could cheer you up? 
1 
2 
3 
4 
5 
6 
26. Have you felt calm and peaceful? 
1 
2 
3 
4 
5 
6 
27. Did you have a lot of energy? 
1 
2 
3 
4 
5 
6 
28. Have you felt downhearted and blue? 
1 
2 
3 
4 
5 
6 
29. Did you feel worn out? 
1 
2 
3 
4 
5 
6 
30. Have you been a happy person? 
1 
2 
3 
4 
5 
6 
31. Did you feel tired? 
1 
2 
3 
4 
5 
6 
 
32. During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting with friends, relatives, etc.)? 
1= All of the time 
2= Most of the time 
3= Some of the time 
4= A little of the time 
5= None of the time 
 
How TRUE or FALSE is each of the following statements for you. 
 
Definitely 
true 
Mostly 
true 
Don’t 
know 
Mostly 
false 
Definitely 
false 
33. I seem to get sick a little easier than other 
people 
1 
2 
3 
4 
5 
34. I am as healthy as anybody I know 
1 
2 
3 
4 
5 
35. I expect my health to get worse 
1 
2 
3 
4 
5 
36. My health is excellent 
1 
2 
3 
4 
5 
 
 
 
 
 


 
 
The Barthel Index
FEEDING 
0= unable 
5= needs help cutting, spreading butter, etc., or requires modified diet 
10= independent 
 
BATHING 
0= dependent 
5= independent (or in shower) 
 
GROOMING 
0= needs to help with personal care 
5= independent face/hair/teeth/shaving (implements provided) 
 
DRESSING 
0= dependent 
5= needs help but can do about half unaided 
10= independent (including buttons, zips, laces, etc.) 
 
BOWELS 
0= incontinent (or needs to be given enemas) 
5= occasional accident 
10= continent 
 
BLADDER 
0= incontinent, or catheterized and unable to manage alone 
5= occasional accident 
10= continent 
 
TOILET USE 
0= dependent 
5= needs some help, but can do something alone 
10= independent (on and off, dressing, wiping) 
 
TRANSFERS (BED TO CHAIR AND BACK) 
0= unable, no sitting balance 
5= major help (one or two people, physical), can sit 
10= minor help (verbal or physical) 
15= independent 
 
MOBILITY (ON LEVEL SURFACES) 
0= immobile or < 50 yards 
5= wheelchair independent, including corners, > 50 yards 
10= walks with help of one person (verbal or physical) > 50 yards 
15= independent (but may use any aid; for example, stick) > 50 yards 
 
STAIRS 
0= unable 
5= needs help (verbal, physical, carrying aid) 
10= independent 
Total Score (0-100): _______ 
 


 
 
Hamilton Anxiety Rating Scale (HAM-A) 
 
 
Not 
present 
Mild  
Moderate  Severe  
Very 
Severe 
1.Anxious mood 
Worries, anticipation of the worst, fearful 
anticipation, irritability 
0 
1 
2 
3 
4 
2.Tension 
Feelings of tension, fatigability, startle response, 
moved to tears easily, trembling, feelings of 
restlessness, inability to relax. 
0 
1 
2 
3 
4 
3.Fears 
Of dark, of strangers, of being left alone, of animals, 
of traffic, of crowds. 
0 
1 
2 
3 
4 
4.Insomnia 
Difficulty in falling asleep, broken sleep, 
unsatisfying sleep and fatigue on waking, dreams, 
nightmares, night terrors. 
0 
1 
2 
3 
4 
5.Intellectual 
Difficulty in concentration, poor memory. 
0 
1 
2 
3 
4 
6.Depressed mood 
Loss of interest, lack of pleasure in hobbies, 
depression, early waking, diurnal swing. 
0 
1 
2 
3 
4 
7.Somatic (muscular) 
Pains and aches, twitching, stiffness, myoclonic 
jerks, grinding of teeth, unsteady voice, increased 
muscular tone. 
0 
1 
2 
3 
4 
8.Somatic (sensory) 
Tinnitus, blurring of vision, hot and cold flushes, 
feelings of weakness, pricking sensation. 
0 
1 
2 
3 
4 
9.Cardiovascular Symptoms 
Tachycardia, palpitations, pain in chest, throbbing 
of vessels, fainting feelings, missing beat. 
0 
1 
2 
3 
4 
10.Respiratory Symptoms 
Pressure or constriction in chest, choking feelings, 
sighing, dyspnea. 
0 
1 
2 
3 
4 


 
 
11.Gastrointestinal Symptoms 
Difficulty in swallowing, wind abdominal pain, 
burning sensations, abdominal fullness, nausea, 
vomiting, borborygmi, looseness of bowels, loss of 
weight, constipation. 
0 
1 
2 
3 
4 
12.Genitourinary Symptoms 
Frequency of micturition, urgency of micturition, 
amenorrhea, menorrhagia, development of frigidity, 
premature ejaculation, loss of libido, impotence 
0 
1 
2 
3 
4 
13.Autonomic Symptoms 
Dry mouth, flushing, pallor, tendency to sweat, 
giddiness, tension headache, raising of hair. 
0 
1 
2 
3 
4 
14.Behavior at interview 
Fidgeting, restlessness or pacing, tremor of hands, 
furrowed brow, strained face, sighing or rapid 
respiration, facial pallor, swallowing, etc. 
0 
1 
2 
3 
4 
 
 
Total Score: _______ 
 
 
 


 
 
Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet & Farley, 
1988) 
 
 
Very 
strongly 
disagree 
Strongly 
disagree 
Mildly 
disagree Neutral 
Mildly 
agree 
Strongly 
agree 
Very 
strongly 
agree 
 
1. There is a special person 
who is around when I am in 
need. 
1 
2 
3 
4 
5 
6 
7 
SO 
2. There is a special person 
with whom I can share my 
joys and sorrows. 
1 
2 
3 
4 
5 
6 
7 
SO 
3. My family really tries to 
help me. 
1 
2 
3 
4 
5 
6 
7 
Fam 
4. I get the emotional help 
and support I need from my 
family. 
1 
2 
3 
4 
5 
6 
7 
Fam 
5. I have a special person 
who is a real source of 
comfort to me. 
1 
2 
3 
4 
5 
6 
7 
SO 
6. My friends really try to help 
me. 
1 
2 
3 
4 
5 
6 
7 
Fri 
7. I can count on my friends 
when things go wrong. 
1 
2 
3 
4 
5 
6 
7 
Fri 
8. I can talk about my 
problems with my family. 
1 
2 
3 
4 
5 
6 
7 
Fam 
9. I have friends with whom I 
can share my joys and 
sorrows. 
1 
2 
3 
4 
5 
6 
7 
Fri 
10. There is a special person 
in my life who cares about my 
feelings. 
1 
2 
3 
4 
5 
6 
7 
SO 
11. My family is willing to help 
me make decisions. 
1 
2 
3 
4 
5 
6 
7 
Fam 
12. I can talk about my 
problems with my friends. 
1 
2 
3 
4 
5 
6 
7 
Fri 
 
The items tended to divide into factor groups relating to the source of the social support, namely family (Fam), 
friends (Fri) or significant other (SO) 
 
Total Score: _______ 
 
 
. 


 
 
LEVEL 2—Sleep Disturbance—Adult* 
 
*PROMIS—Sleep Disturbance—Short Form 
  
If the measure is being completed by an informant, what is your relationship with the individual receiving care? 
__________________ 
 
In a typical week, approximately how much time do you spend with the individual receiving care? __________________ 
hours/week 
  
In the past SEVEN (7) DAYS.... 
 
Not at all 
A little bit 
Somewhat  Quite a bit 
Very much 
1. My sleep was restless. 
 
1 
2 
3 
 
4 
5 
2. I was satisfied with my sleep. 
 
5 
4 
3 
 
2 
1 
3. My sleep was refreshing. 
 
5 
4 
3 
 
2 
1 
4. I had difficulty falling asleep. 
 
1 
2 
3 
 
4 
5 
In the past SEVEN (7) DAYS.... 
 
Never 
Rarely 
Sometimes  
Often 
Always 
5. I had trouble staying asleep. 
 
1 
2 
3 
 
4 
5 
6. I had trouble sleeping. 
 
1 
2 
3 
 
4 
5 
7. I got enough sleep. 
 
5 
4 
3 
 
2 
1 
In the past SEVEN (7) DAYS.... 
 
Very Poor 
Poor 
Fair 
 
Good 
Very good 
8. My sleep quality was... 
 
5 
4 
3 
 
2 
1 
 
 
 
Total/Partial Raw Score: _______ 
Prorated Total Raw Score: _______ 
T-Score: _______ 
 


 
 
Self-Report Health Service Utilization and Medication Use 
 
INTERVIEWER: Did the patient respond to these questions at a previous interview? 
 
If Yes, SKIP to section 3. If No, continue 
Lifetime utilization questions should only be asked once during the 12 month follow-up period. 
 
___ Yes (1) __No (0) 
 
Now I am going to ask you a few questions about your health services utilization. 
  
 
 
 
 
1. 
 
 
 
 
2. 
 
 
 
Other than this hospitalization, how many times in your lifetime, before this injury, 
have you been hospitalized? 
 
_______ Times 
___Patient Refused (-9) 
 
In your lifetime, before this injury, how many times have you visited an emergency 
department? 
_______________ Times 
___Patient Refused (-9)


 
 
 
 
1. 
In your lifetime, before this injury, had you ever had at least one 
outpatient visit with a psychiatrist, psychologist, social worker, psychiatric 
nurse, counselor or other similar professional about problems with your 
emotions, nerves, or use of substances? Have you seen a… 
 
3a. 
Psychiatrist 
 
3b. 
General practitioner or family doctor 
 
3c. 
Any other medical doctor (GYN, urologist, etc.) 
 
3d. 
Psychologist 
 
3e. 
Social Worker 
 
3f. 
Counselor 
 
3g . 
Any kind of substance abuse or chemical dependency treatment, like AA, 
NA a sobering center, or detox 
 
3h. 
Any other mental health professional 
 
3i. 
Nurse, occupational therapist, or other health profession 
 
3j. 
Religious or spiritual advisor like a minister, rabbi, or priest 
 
3k. 
Any other healer, like an herbalist, chiropractor, or spiritualist 
 
 
 
 
 
 
Yes 
No 
Patient 
Refused 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
1 
0 
-9 
 
 
 
 
4. During the year prior to your injury, did you have an outpatient visit 
with a psychiatrist, psychologist, social 
counselor or other similar professional about problems with your 
Patient 
emotions or nerves, or use of alcohol? 
Yes (1) 
No (0) 
Refused 
If yes, how many visits did you have with each of the following provider, 
(-9) 
and what were the visits for? 


 
 
 
4a. 
Psychiatrist 
# visits 
What for? 
4b. 
General practitioner or family doctor 
# visits 
What for? 
4c. 
Any other medical doctor (GYN, urologist, etc.) 
# visits 
What for? 
4d. 
Psychologist 
# visits 
What for? 
4e. 
Social Worker 
# visits 
What for? 
4f. 
Counselor 
# visits 
What for? 
4g. 
Any kind of substance abuse or chemical dependency treatment, 
# visits 
What for? 
like AA, NA a sobering center, or detox 
4h. 
Any other mental health professional 
# visits 
What for? 
4i. 
Nurse, occupational therapist, or other health profession 
# visits 
What for? 
4j. 
Religious or spiritual advisor like a minister, rabbi, or priest 
# visits 
What for? 
4k. 
Any other healer, like an herbalist, chiropractor, or spiritualist 
# visits 
What for? 
  
 
 
 
5. Since your last study interview on ____/_____/_____ did you have 
an  outpatient  visit  with  a  psychiatrist,  psychologist,  social  worker, 
Patient 
psychiatric nurse, counselor or other similar professional about problems 
with your emotions or nerves, or use of alcohol? 
Yes (1) 
No (0) 
Refused 
If yes, how many visits did you have with each of the following provider, 
(-9) 
and what were the visits for? 
 
 
 
 
 
5a. 
Psychiatrist 
# visits 
What for? 
5b. 
General practitioner or family doctor 
# visits 
What for? 
 
5c. 
Any other medical doctor (GYN, urologist, etc.) 
# visits 
What for? 


 
 
 
5d. 
Psychologist 
# visits 
What for? 
5e. 
Social Worker 
# visits 
What for? 
5f. 
Counselor 
# visits 
What for? 
5g.      Any kind of substance abuse or chemical dependency treatment, 
# visits 
What for? 
like AA, NA a sobering center, or detox 
5h.      Any other mental health professional 
# visits 
What for? 
5i.       Nurse, occupational therapist, or other health profession 
# visits 
What for? 
5j.       Religious or spiritual advisor like a minister, rabbi, or priest 
# visits 
What for? 
5k.      Any other healer, like an herbalist, chiropractor, or spiritualist 
# visits 
What for? 
 
How many times since your last study interview on ______/________/_______, have you 
been a patient over night or longer in a hospital for any reason? 
6a. 
________ # times 
If you can recall the first hospitalization since ______/_____/_____,, can you tell me: 
6b. 
[6b1.] 
Where you were seen: 
[6b2.] 
What your primary complaint was: 
[6b3.] 
How many days you were in the hospital: 
[6b4.] 
Was this related to your original injury 
hospitalization? 
If you can recall the second hospitalization, can you tell me: 
6c. 
[6c1.] 
Where you were seen: 
[6c2.] 
What your primary complaint was: 
[6c3.] 
How many days you were in the hospital: 
[6c4.] 
Was this related to your original injury 
hospitalization? 
If you can recall the third hospitalization, can you tell me: 
6d. 
[6d1.] 
Where you were seen: 
[6d2.] 
What your primary complaint was: 
 


 
 
 
 [6d3.]        How many days you were in the hospital: 
 
[6d4.] 
Was this related to your original injury 
 
hospitalization? 
  
 
 
Since your last study interview on ______/_______/________, how many visits did you make to an 
 
 emergency room? 
 
________ # visits 
 
7a. 
If you can recall the first visit since ______/_____/_____, can you tell me: 
7b. 
[7b1.] 
What was the visit for? 
[7b2.] 
Where were you seen? 
If you can recall the second visit, can you tell me: 
7c. 
[7c1.] 
What was the visit for? 
[7c2.] 
Where were you seen? 
If you can recall the third visit, can you tell me: 
7d. 
[7d1.] 
What was the visit for? 
 
 [7d2.]   Where were you seen? 
  
 
 
Since your last study interview on _____/______/______, how many visits did you make to a Skilled 
Nursing Facility or Rehabilitation Center? 
 
________ # visits 
 
8a. 
8b. 
 
If you can recall the first visit since ______/_____/_____, can you tell me: 
[8b1.] 
Where you were seen: 
 
[8b2.] 
What your primary complaint was: 
 
[8b3.] 
How many days you were in the facility: 
 
 
 
   
 
 
 


 
 
 
I will read a list of providers to you and I’d like you to tell me how many times since your last stud interview 
on ______/______/_______ you’ve seen each one. Please do not include visits to the emergency 
 room, overnight stays in a hospital, nursing home, or other health care facility. 
9a. 
Family Doctor 
 
9b. 
Internal Medicine Doctor 
 
9c. 
Nurse Practitioner 
 
9d. 
Surgeon 
 
9e. 
Neurologist or Pain Specialist 
 
9f. 
Rehabilitation Medicine Doctor or Physical Therapist 
 
9g. 
Obstetrician or Gynecologist (if male, write N/A, data entry -7) 
 
9h. 
Lab tests and/or blood draws 
 
9i. 
Any other healer, like an herbalist, chiropractor, or spiritualist 
 
9j. 
Radiology (e.g. MRI, X-ray, Cat Scan) 
 
9k. 
Other (specify other: ______________________________) 
 
 
Total Score: _______ 
 
 


 
 
FATIGUE SEVERITY SCALE (FSS) 
 
Read and circle a number. 
Strongly Disagree 
→ 
Strongly Agree 
 
1. My motivation is lower when I am 
1 
2 
3 
4 
5 
6 
7 
fatigued. 
2. Exercise brings on my fatigue. 
1 
2 
3 
4 
5 
6 
7 
3. I am easily fatigued. 
1 
2 
3 
4 
5 
6 
7 
4. Fatigue interferes with my physical 
1 
2 
3 
4 
5 
6 
7 
functioning. 
5. Fatigue causes frequent problems for 
1 
2 
3 
4 
5 
6 
7 
me. 
6. My fatigue prevents sustained physical 
1 
2 
3 
4 
5 
6 
7 
functioning. 
7. Fatigue interferes with carrying out 
1 
2 
3 
4 
5 
6 
7 
certain duties and responsibilities. 
8. Fatigue is among my most disabling 
1 
2 
3 
4 
5 
6 
7 
symptoms. 
9. Fatigue interferes with my work, family, 
1 
2 
3 
4 
5 
6 
7 
or social life. 
 
 
 
 
VISUAL ANALOGUE FATIGUE SCALE (VAFS) 
Please mark an “X” on the number line which describes your global fatigue with 0 being worst and 10 being normal. 
 
   
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
Total Score: _______ 
 
 
 
______________________________________________________________________________ 


 
 
Please respond to each question or statement by marking one box per row. 
 
Without 
With a 
With 
With 
  
Physical Function 
any 
little 
some 
much 
Unable 
difficulty 
difficulty 
difficulty 
difficulty 
to do 
PFA11 
Are you able to do chores such as 
vacuuming or yard work? .......................... 
Are you able to go up and down stairs at a 
normal pace?.............................................. 
Are you able to go for a walk of at least 
15 minutes?................................................ 
Are you able to run errands and shop? ...... 
Anxiety 
In the past 7 days… 
I felt fearful................................................ 
I found it hard to focus on anything other 
than my anxiety ......................................... 
My worries overwhelmed me .................... 
I felt uneasy ............................................... 
Depression 
In the past 7 days... 
I felt worthless ........................................... 
I felt helpless.............................................. 
I felt depressed........................................... 
I felt hopeless............................................. 
Fatigue 
During the past 7 days… 
I feel fatigued ............................................. 
 
 
5 
4 
 
 
5 
4 
 
 
5 
4 
 
 
5 
4 
  
Never 
Rarely 
 
 
1 
2 
 
 
1 
2 
 
 
1 
2 
 
 
1 
2 
Never 
Rarely 
 
 
1 
2 
 
 
1 
2 
 
 
1 
2 
 
 
1 
2 
    Not at all 
A little bit 
 
 
1 
2 
 
 
 
3 
2 
1 
 
 
 
3 
2 
1 
 
 
 
3 
2 
1 
 
 
 
3 
2 
1 
Sometimes 
Often 
Always 
 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
Sometimes 
Often 
Always 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
Somewhat 
Quite a bit 
Very much  
 
 
 
3 
4 
5 
  
PFA21 
 
PFA23 
PFA53 
 
EDANX01 
EDANX40 
EDANX41 
EDANX53 
 
EDDEP04 
 
EDDEP06 
 
EDDEP29 
 
EDDEP41 
  
HI7 
AN3 
I have trouble starting things because I 
am tired...................................................... 
 
 
1 
2 
 
 
 
3 
4 
5 


 
 
Fatigue 
In the past 7 days… 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
FATEXP41 How run-down did you feel on average? ... 
How fatigued were you on average? .......... 
Sleep Disturbance 
In the past 7 days… 
My sleep quality was.................................. 
In the past 7 days… 
My sleep was refreshing............................. 
I had a problem with my sleep .................. 
I had difficulty falling asleep .................... 
Ability to Participate in Social Roles 
and Activities 
I have trouble doing all of my regular 
leisure activities with others .................... 
I have trouble doing all of the family 
activities that I want to do ....................... 
I have trouble doing all of my usual work 
(include work at home) ........................... 
I have trouble doing all of the activities 
with friends that I want to do .................. 
Pain Interference 
In the past 7 days… 
How much did pain interfere with your 
day to day activities? .................................. 
How much did pain interfere with work 
around the home? ....................................... 
How much did pain interfere with your 
ability to participate in social activities? . 
 
 
1 
2 
 
 
1 
2 
Very poor 
Poor 
 
 
5 
4 
    Not at all 
A little bit 
 
 
5 
4 
 
 
1 
2 
 
 
1 
2 
Never 
Rarely 
 
 
5 
4 
 
 
5 
4 
 
 
5 
4 
 
 
5 
4 
Not at all 
A little bit 
 
 
1 
2 
 
 
1 
2 
 
 
1 
2 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
Fair 
Good 
Very good 
 
 
 
3 
2 
1 
Somewhat 
Quite a bit 
Very much  
 
 
 
3 
2 
1 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
Sometimes 
Usually 
Always 
 
 
 
3 
2 
1 
 
 
 
3 
2 
1 
 
 
 
3 
2 
1 
 
 
 
3 
2 
1 
Somewhat 
Quite a bit 
Very much 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
 
 
 
3 
4 
5 
FATEXP40 
 
Sleep109 
Sleep116 
Sleep20 
Sleep44 
SRPPER11 
_CaPS 
SRPPER18 
_CaPS 
SRPPER23 
_CaPS 
SRPPER46 
_CaPS 
PAININ9 
 
PAININ22 
 
PAININ31 
PAININ34 
How much did pain interfere with your 
household chores? ..................................... 
 
 
1 
2 
 
 
 
3 
4 
5 


 
 
 
  
Pain Intensity 
In the past 7 days… 
Global07 
  
How would you rate your pain on 
average?.......................................... 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
  
No 
pain 
Worst 
imaginable 
pain