COMRADE: Collaborative Care Management for Distress and Depression in Rural Diabetes
Phase: NA
Conditions: Type 2 Diabetes Mellitus, Diabetes-related Distress, Depression
Sponsor: East Carolina University

COMRADE: Collaborative Care Management for Distress and Depression in 
Rural Diabetes 
NCT02863523 
December 11, 2017 
 
 

PROTOCOL AND DATA ANALYSIS 
1. Introduction 
Type 2 diabetes (T2D), a significant public health burden, is more prevalent in the southeastern 
US which includes most of the CDC defined “Diabetes Belt” [1]. It is estimated that 9.3% of 
Americans have diabetes and in the counties included in the Diabetes Belt; the percent affected 
ranges from 11 to 11.7%. Those with T2D are twice as likely to have symptoms of depression 
and this relationship may be bi-directional [2]. Depressive symptoms may also interfere with 
glycemic control and adherence to the prescribed treatment regimen [3]. Diabetes related 
distress, originally investigated by Polonsky et al. [4], can be associated with depressive 
symptoms but appears to be a distinct condition [5]. Diabetes related distress reflects the 
emotional distress, defined as “patient concerns about disease management, support, emotional 
burden, and access to care”. High levels of regimen related distress have been associated with 
poor medication adherence, lower self-efficacy, and higher levels of HbA1c [6]. Early evidence 
suggests that improvement in depressive symptoms and/or distress have been associated with 
improvement in glycemic control and quality of life [7–9]. Katon et al. [7] described a shared or 
integrated approach to both T2D and depression using a care manager specifically trained in 
both diseases, with psychiatrist back-up. However, Katon et al.'s work was done in the 
northwestern US with a predominantly Caucasian population with diabetes and depression only 
(distress not targeted) with good access to medical care services and the availability of back-up 
psychiatrists. Bogner et al. [8] implemented an integrated care management strategy for patients 
with T2D and co-morbid depression who were likely to have medication adherence challenges. 
This study also provided excellent evidence for the present study; however, it was conducted in 
an urban setting in the northeastern US, targeted depressive symptoms only, and outcomes were 
only measured at 12 weeks so that the long-term effect of their model is unknown. Hessler et al. 
[9] used an electronic intervention model and showed that reductions in regimen-related distress 
were associated with improvements in medication adherence and glycemic control. However, 
this study was conducted in an urban location on the west coast. Despite the limitations of 
available data, the American Diabetes Association in its latest guidelines [10] now recommends 
both regular screening for psychosocial issues as well as evaluation and treatment including a 
collaborative patient-centered approach involving behavioral health professionals when 
indicated. However, the extent to which this collaborative behavioral and medical care model 
can be effectively implemented in busy primary care practices in the southeastern US diabetes 
belt or other areas of high prevalence, where many patients with poorly controlled T2D and 
behavioral co-morbidities are managed, remains poorly defined. The investigators undertook the 
present study to investigate the pragmatic implementation of an integrated care delivery model 
in the diabetes belt in the rural southeastern United States with a much larger African American 
population. 
In this protocol, the authors describe the design, rationale, and methods from a prospective 
randomized pragmatic trial of an innovative model involving a culturally-relevant integrated 
medical and behavioral intervention for uncontrolled T2D, tailored to the unique needs of 
patients in the southeastern US diabetes belt. The objective of this clinical trial was to determine 

the feasibility for delivering and evaluating coordinated and integrated behavioral and medical 
care for adult patients with uncontrolled T2D who have comorbid diabetes-related distress 
and/or depressive symptoms, in the context of a busy primary care practice and surrounding 
rural communities. The intervention included a carefully defined protocol for face-to-face and 
telephone delivered cognitive behavioral health interventions, tailored to the presence and 
severity of co-morbid distress and/or depression, in addition to routine medical care for T2D. 
2.2. Intervention design 
The study was designed as a prospective, randomized, non-blinded pragmatic trial with 
randomization at the patient level to the intervention arm or to usual care. For the intervention 
arm, a collaborative or integrated care model involving tailored cognitive-behavioral therapies 
plus American Diabetes Association guideline [10]-informed standard medical care was 
considered to represent the most practical approach to treating the established co-morbid illness 
in busy primary care settings in the southeastern US. The intervention was designed to utilize 
modified versions of evidence-based collaborative care management strategies – particularly 
those described by Katon et al. [7] and Banger et al. [8]. Further, the intervention model was 
built on the authors' prior work [11], and was designed to: 
1. Involve an integrated and collaborative care delivery system that extends the capacity of busy 
primary care providers to be able to screen and manage the psychological and behavioral needs 
of complex co-morbid patients with T2D 
2. Focus on specific behavioral problems such as depressive and diabetes-related distress 
symptoms that prior literature suggests limits optimal care outcomes 
3. Utilize a unique stepped care approach that quickly moves the patient to the right level of 
care and increases or decreases the degree of intervention based on patient response 
4. Be culturally tailored to be relevant in the southeastern US and to African Americans 
5. Use a trained care manager linked to primary care clinicians and health psychologists so that 
it might be readily deployed even in communities without access to a psychiatrist  
6. Employ a community health worker to provide specific social support and navigation 
7. Use a combined face-to-face and telephone visit structure to improve care and cost efficiency 
and to facilitate generalizability in underserved and rural communities 
2.3. Study population and setting 
The study was specifically targeted at patients with uncontrolled T2D who also reported either 
depressive symptoms and/or symptoms of diabetes-related distress, as measured by previously 
validated instruments (see below). In our prior pilot work in this same region using the same 
instruments [11], 40% of patients screened positive for diabetes related distress and 21.5% 
reported elevated depressive symptoms. The study took place in an academic Family Medicine 
clinic setting that included a residency program located in the southeastern U.S. 
2.3.1. Screening 

The population screened for this study included: adult patients (18 to 75 years of age) who had 
established care at the academic primary care practice (at least one visit in the last 12 months) 
and who had an electronic medical record established diagnosis of T2D and a recent (< 12 mo.) 
HbA1c that reflected inadequate glycemic control (HbA1c≥7.0). Exclusion criteria for screening 
included a medical record established diagnosis of advanced disease (e.g., end stage renal 
disease, advanced heart failure, blindness, metastatic cancer) or the presence of alcoholism, 
cognitive impairment, or major psychiatric disease that would preclude active participation. 
Individuals who met preliminary eligibility were contacted by the study coordinator and invited 
to be seen for a study-specific visit or was screened following a regular provider visit. At the 
time of placement into an examination room for the study visit, a statement of informed consent 
and HIPPA consent was carefully reviewed with each potential participant. A two-item version 
of the Diabetes Distress Scale (DDS-2) and the two-item version of the Patient Health 
Questionnaire (PHQ-2) was then administered as a screening instrument by office staff. These 
2-item versions have excellent sensitivity (95% and 97%, respectively), and are defined in 
greater detail below in the outcome measures section. Study staff collected the completed 
measures and scored them. If the score on either measure was considered positive (mean score > 
3 on DDS-2; total score > 3 on PHQ-2), the individual was assessed regarding glycemic control. 
A screening fingerstick HbA1c test was obtained while the patient was in the examination room 
and evaluated using a Siemens analyzer [DCA Vantage portable analyzer, Siemens Medical 
Solutions, Malvern, PA] as described below. If the patient met all the screening criteria 
described above, had a HbA1c value that day that was>7.0, and also had positive co-morbid 
behavioral symptoms (depressive and/or diabetes-related distress symptoms on one or more of 
the 2 item screening instruments), then he/she was scheduled for an enrollment visit into the 
study. Once enrolled, the patient completed the full DDS-17 and PHQ-9 plus additional baseline 
instruments that are defined below and was then scheduled for a study orientation visit. 
2.4. Sample size and randomization procedures 
Sample size was estimated as follows. The primary outcome measure was determined to be the 
change in mean HbA1c from baseline to 12-months follow-up. In the intervention arm, mean 
HbA1c was hypothesized to decrease by −0.7 compared to no change in the usual care arm 
(based on values reported by Bogner et al. [8]). Using an α = 0.05 and a power estimate of 0.80, 
the crude sample size needed in each group was approximately n=50 for a total sample size of 
N=100 patients. The investigators chose to recruit and randomize approximately 70 patients into 
each arm anticipating the possibility of dropouts and incomplete follow-up data in some 
patients. Randomization was designed as a blocked randomization process, controlled by one of 
the investigators, using a computer-generated allocation sequence with allocation concealment 
from treating providers, with eligible patients randomized in blocks of four to the intervention 
or control group. Patients were randomized at the beginning of the orientation visit, held one 
week after the screening visit) and were provided group specific orientation to the study as 
detailed below. 
2.5. Implementation 

At the outset of the study, project faculty met weekly and hired a project coordinator who 
managed logistics and facilitated patient recruitment as well as all data collection and data entry. 
2.5.1. Intervention staff selection and training 
The primary intervention was delivered by a team of behavioral providers working together 
including a nurse care manager who provided small-changes lifestyle coaching [11], a doctoral 
student in clinical psychology or psychologist who provided cognitive behavioral treatment 
sessions including elements of problem-solving therapy where indicated, and a community 
health worker who provided navigation and social support. The nurse care manager was an 
African American registered nurse from the local area with>10 years' experience in care 
management for patients with diabetes. A local African American adult female community 
health worker with>10 years' experience in chronic disease care, was hired to provide social 
support and navigation in the community to acquire needed diabetes resources. All staff hired 
had strong interpersonal skills including a demonstrated ability to establish rapport quickly with 
a wide range of people. The nurse manager and other intervention staff received extensive (≥80 
h) training by the investigators in all aspects of the intervention including diabetes-specific 
evaluation and management, depression and distress specific evaluation and management, 
cognitive-behavioral/problem solving therapy intervention components, disease and severity 
stratification, response evaluation and stepped-care transitions, psychological and medical 
treatment intensification, working with providers and community partners, and project-specific 
evaluation. One of the investigators provided regular supervision of the care manager from a 
behavioral intervention perspective. 
2.5.2. Orientation session 
Patients who completed the screening visit and signed informed consent completed a study 
orientation visit one week later during which height, weight, and sitting blood pressure (BP) 
were measured using standardized procedures. All patients in both study arms were provided 
with educational materials about T2D (Living with Diabetes, American College of Physicians, 
Product #: 11033420E). Patients randomized at the orientation visit into the Usual Care Arm 
were provided with general information about the COMRADE study and with a brief 
orientation to future study assessment visits. Patients randomized to the intervention group were 
provided with general information about the COMRADE study, a weight scale, and were 
assigned to one of two levels of behavioral treatment based on the level of baseline scores (see 
below). Intervention group patients also received an innovative, patient-friendly Tracking for 
Success Calendar developed for daily monitoring of six possible diabetes and mood self-
management behaviors including fasting blood glucose, weight, medication administration, food 
intake, step count, and mood. Each intervention arm patient was instructed to use this for the 
duration of the study and these records were reviewed at the start of every study-related session 
by the assigned behavioral interventionist. Following explanation of study materials and 
orientation to the COMRADE program, patients were scheduled to attend their first behavioral 
treatment session. 
2.5.3. Initial assessment of co-morbid behavioral symptoms and severity stratification 

Once randomized at the orientation visit, patients in both groups completed a full battery of 
measures which are detailed below. The full psychological measures [Patient Health 
Questionnaire-9 (PHQ-9) for depressive symptoms and the Diabetes-related Distress-17 (DDS-
17) scales for diabetes-related distress symptoms], were promptly scored by study staff and used 
to triage or stratify patients into one of two appropriate evidence-based behavioral interventions 
based on the severity of symptoms of depression or distress [(Small Changes Lifestyle 
Coaching if PHQ-9 < 10 and/or mean DDS-17 < 3) or Cognitive Behavioral Therapy (CBT; 
PHQ-9≥10 and/or mean DDS-17 – ≥3.0)]. Based on these two measures, it was possible to have 
patients with only depressive symptoms, only diabetes-related distress symptoms, or a 
combination of both distress and depressive symptoms. This complex design was specifically 
chosen for pragmatic reasons related to: 1) insuring generalizability in primary care where 
patients with uncontrolled diabetes frequently have either or both of these co-morbidities, and 2) 
to explore whether evidence-based but tailored treatments would relieve varying levels of 
symptoms of diabetes-related distress and/or depression and facilitate diabetes control when 
delivered in this integrated care fashion in the context of a busy primary care practice. The 
proposed stratification design may also have the potential to be more efficient and cost-effective 
than providing a potentially suboptimal level of intervention for a period of time before 
intensifying treatment as might occur in a standard stepped care model. Therefore, the 
behavioral intervention was designed to pilot test a severity-stratified behavioral treatment 
model with patients being triaged at baseline to one of three levels of behavioral intervention 
(small changes lifestyle coaching, or one of two levels of cognitive behavioral therapy), each 
paired with guideline informed standard medical care delivered by the patient's primary care 
provider with available consultative support from the study's diabetologist to assist with 
medication selection and monitoring. All three levels of behavioral health intervention had the 
overarching goal of improving the patient's glycemic control (i.e., HbA1c) as well as improving 
depressive and/or distress symptoms. 2.5.4. Behavioral health intervention structure and content 
In the first 6 months of behavioral treatment all patients in the intervention arm received one 
individual orientation session and 12 individually tailored behavioral treatment sessions that 
included the content described below, delivered by the study staff (trained nurse or health 
psychologist/doctoral clinical health psychology student) described above. Patients completed 
the orientation session and the first intervention session for each level of behavioral intervention 
in-person and then had the choice of completing the subsequent sessions either in-person or by 
telephone. Session duration ranged from 30 to 60 min depending on treatment content and 
individual patient needs; patients were not charged for the behavioral intervention. All study 
interventionists met bi-weekly as a group with the principal investigators for supervision and 
consultation. The registered nurse met one-on-one weekly for supervision with the licensed 
clinical psychologist principal investigator. The diabetologist (i.e., primary care physician with 
advanced training in diabetes care) was also on-site and available for consultation and referral 
of patients who developed severe diabetes signs or symptoms (e.g., hypoglycemia, 
hyperglycemia). 
2.5.5. Small changes lifestyle intervention 

The Small Changes treatment sub-group included intervention arm patients with low levels of 
diabetes-related distress and/or depressive symptoms and the intervention focused on lifestyle 
modifications to improve diabetes and mood based on the Small Changes health behavior 
change model [12] as we have previously described [11], as well as American Diabetes 
Association (ADA) [10] recommended diabetes education topics of healthy eating, being active, 
monitoring, taking medication regularly, healthy coping, and decreasing risks. The Small 
Changes model encourages health behavior change and maintenance through the use of 
incremental goals over time that are self-selected by patients and relative to their baseline. The 
Small Changes approach has been shown to be more effective for weight loss than traditional 
treatment in a health care setting with Veterans [13]. Small Changes lifestyle intervention 
sessions were delivered by a nurse trained in behavior change and focused on the development 
of self-management strategies and the setting of SMALL (specific, measurable, action-oriented, 
linked-to-your-life, and long-term) goals. Patients were instructed to self-monitor and record 
daily fasting finger stick blood sugar (FSBS), weight, mood, medication taking, and selected 
nutritional intake (using only check marks) using the provided calendar and scale as well as 
their daily steps with pedometers provided by the study. Nutritional monitoring and goal setting 
was based on a Stop Light Guide [14] which was adapted for diabetic populations. In this 
modified system, food and beverage items were categorized as “Green” (high nutrient value, 
little effect on glycemic control), “Yellow” (high nutrient value, moderate effect on glycemic 
control), and “Red” (low nutrient value, large effect on glycemic control). While patients were 
introduced to the full modified Stop Light Guide, patients were instructed only to monitor how 
many red foods they were eating daily and make relative nutritional changes to their daily 
baseline consumption of “Red Foods”. Specifically, patients checked-off daily servings of Red 
Foods in five categories (breakfast, lunch, dinner, snacks, and beverages) in order to get a daily 
total of Red Food servings (sum from these five categories) and then set goals to reduce their 
daily total throughout the course of treatment. Monitoring and goal setting was designed in this 
manner to reduce monitoring burden and to increase the patient's focus on food and beverage 
items with potential for substantial adverse impact on weight and glycemic control. 
2.5.6. Cognitive behavioral therapy 
The Cognitive Behavioral Therapy (CBT) subgroup focused on the reduction of depressive 
and/or diabetes-related distress symptoms through modification of negative thoughts and 
problematic behaviors as well as improvement of diabetes self-management strategies. CBT 
combines cognitive therapy, which targets maladaptive thinking that impacts emotions and 
behavior with behavioral therapy which directly targets the behaviors which impact mood. CBT 
intervention components were guided by two evidence-based treatment manuals [15,16] as well 
as an evidence-based manual [17] for behavioral activation. Session content utilized cognitive 
techniques to identify and challenge general and diabetes-specific cognitive distortions that 
result in maladaptive behavior; and behavioral techniques including behavioral activation and 
specific behavior change related to diabetes and/or mood (self-monitoring, sleep hygiene, eating 
habits etc.). Patients were taught behavioral strategies to become re-engaged in pleasant 
activities (behavioral activation) as well as cognitive techniques to identify and then challenge 
cognitive distortions that result in negative automatic thoughts and subsequent maladaptive 

behavior. These sessions occurred in 50 min face-to-face (in private therapy rooms in the 
primary care clinic) or via telephonic visits with the health psychologist/student. Problem-
solving strategies were utilized as needed to assist with behavioral goals related to mood and 
diabetes management. 
CBT Therapy was also tailored to individual patient needs. For patients who met criteria for this 
subgroup but who had more intermediate levels of depressive or distress symptoms, the health 
psychologist utilized Problem Solving Therapy (PST), a variant of CBT which focuses on 
facilitation of effective coping and adaptive problem-solving skills [18]. Problem Solving 
Therapy has been shown to be an effective intervention strategy for improvement in both 
diabetes specific outcomes and depression [19,20], particularly in patients with lower 
socioeconomic status and diabetes [21]. Problem Solving Therapy has also been adapted for 
delivery in primary care settings (PST-PC) as a brief form of evidence-based psychotherapy 
[22] and is supported by randomized controlled studies in primary care settings [23]. Patients 
receiving CBT involving PST began treatment by compiling a personalized on-going list of 
“problems” or areas for potential improvement based on ADA recommended [10] diabetes 
topics. In each session, the patient chose a problem from his or her list to address and used the 
following steps: 1) problem definition, 2) establishment of realistic goals for problem 
resolution, 3) generation of multiple solution alternatives, 4) determination of the pros and cons 
of solution alternatives 5) evaluation and solution choice, 6) implementation of the preferred 
solution, and 7) evaluation of the outcome. Additionally, patients were provided education 
about behavioral activation for mood improvement and were assisted with setting goals to 
increase engagement in pleasurable activities for improved mood. Primary care providers for 
patients in the intervention arm were offered consultation with the diabetologist and, when 
needed, consultation with a clinical pharmacist to optimize medical management. Primary care 
providers were instructed to titrate medication dosages to appropriate therapeutic dosages based 
on finger-stick blood sugar response and subsequent HbA1c values. Patient response, 
adherence, and potential for side effects were monitored regularly by the nurse care manager 
during face-to-face and telephone follow-up, with particular attention to the potential for 
hypoglycemia associated with insulin and sulfonylurea drugs. 
2.5.7. Community based support of the intervention 
All intervention patients had access to a trained Community Health Worker (CHW) who had 
extensive experience promoting healthy behaviors for chronic disease management in the 
targeted region. This CHW component of the intervention was designed as culturally relevant 
peer support and as a navigator to community resources that helped patients address logistical 
challenges to implementing healthy behaviors, problem solving, and accessing healthy 
food/activity in the target community. The CHW contacted each intervention patient by phone 
approximately quarterly and offered logistical and navigational support as well as 
encouragement for behavioral change.  
2.5.8. Usual care group (control) 

Patients in the control group received the educational materials described above (i.e., Living 
with Diabetes book) and continued to receive usual care at their primary care provider's office. 
2.5.9. Overall study evaluation 
The authors evaluated the effectiveness of this stratified integrated behavioral health model on 
diabetes related distress, depressive symptoms, and diabetes outcomes (see measures below) at 
6- and 12-month follow-up visits. It was hypothesized that the collaborative behavioral health 
intervention would produce greater improvement in diabetes related distress, depressive 
symptoms, as well as HbA1c at 6 and 12 months vs. usual care. A priori analyses were also 
designed to evaluate mediators of the relationship between improvement in psychological 
measures (distress/depression) and improvement in HbA1c with the hypothesis that the 
intervention-associated improvements in diabetes-related distress, regimen related distress, and 
depressive symptoms would be associated with improvements in A1c in part via association 
with improvements in self-care behaviors. 
2.5.10. Mid-study Re-assessment and maintenance treatment 
At the 6-month mid-study assessment, all patients were re-evaluated using the same measures 
described below, and either continued to receive twice monthly behavioral sessions (for those 
with no improvement in distress and depressive symptom scores) as originally assigned at the 
initial orientation visits, or were transferred to once per month telephonic maintenance follow-
up care (for those whose distress and depressive symptom scores improved). Maintenance 
treatment reinforced prior intervention strategies that produced benefit and provided lifestyle 
behavioral counseling using elements of the small changes model described above) by the nurse 
care manager. 
2.6. Biological and psychosocial measures 
Patients in both intervention and control groups completed a demographic questionnaire [age, 
gender, race (African American, Caucasian, other), highest education level completed (high 
school or less, some college, college degree, any graduate education), marital status (single, 
married, separated, divorced, widowed), annual household income ($ < 40,000/yr. vs.≥
$40,000/yr.) duration of diabetes (yrs.; self-reported), number of doctor visits in the last 12 
months] at baseline; biological and psychosocial assessments were completed at baseline, 6, and 
12 months. Weight was obtained using an Eatsmart Precision Plus Bathroom Scale model 
ESBS-05. Height was measured using a wall stadiometer. Blood pressure was obtained using an 
Omron Intellisense Automatic BP Monitor model BP760 (Omron, Inc., Chicago, IL) using a 
standardized protocol. All patients were seated for five minutes with both feet on the floor, and 
with their arm supported. Blood pressure was measured twice and averaged. HbA1c was 
measured by fingerstick using the Siemens Medline DCA Vantage 2000 HbA1c Reagent Kit. 
The study utilized previously validated psychosocial measures including the Patient Health 
Questionnaire (PHQ-9), Diabetes Distress Scale (DDS-17), and the Satisfaction with Life Scale 
with data collected at baseline, 6-months, and 12-months. The PHQ-9 is a nine-item self-report 
measure [24] intended for use in primary care settings to assess symptoms of depression. Scores 
can be summed to indicate, minimal, mild, moderate, or severe depressive symptoms. The 

DDS-17 is a 17-item self-reported measure [4] which is designed to indicate a respondent's level 
of current emotional distress related to diabetes management. Scores are summed and divided 
by 17 (i.e., mean score) to categorize distress as low, moderate, or high. The DDS-17 also has 
four subscales, including the Regimen Related Distress sub-score which is an average from five 
items that assess distress associated with specific treatment and monitoring activities, and which 
has been correlated with diabetes outcome measures [6,9]. The Satisfaction with Life Scale [25] 
is a 5-item self-report measure designed to assess satisfaction with a respondent's life as a 
whole. The study also utilized several previously validated health behavior measures including 
the Diabetes Empowerment Scale, The Summary of Diabetes Self-Care Activities Measure 
(SDSCA), the Rapid Eating Assessment for Participants – Shortened Version (REAP-S), and 
the Duke Activity Status Index, with data collected at baseline, 6-months, and 12-months. The 
Diabetes Empowerment Scale-Short Form [26] is an abbreviated self-report measure of 
diabetes-related psychosocial self-efficacy. Dietary habits were assessed using the REAP-S, a 
16-item self-report survey [27] designed for use in primary care to directly assess dietary habits 
for patients with diabetes. Physical activity was assessed by the Duke Activity Status Index, a 
12-item self-report measure [28] to assess functional capacity. 
2.6.1. Data analysis plan 
All data was collected by project staff via in-person interviews/assessments at all time points 
and entered into a REDCap database. Demographic and baseline data will be compared between 
treatment groups; co-variates will be used for any significant differences on subsequent 
analyses. The principal outcome measure, change in HbA1c, and secondary outcome measures 
(e.g., change in DDS-17 score, PHQ-9 score, etc.) from baseline to 12 months of follow-up, will 
be compared (intervention group vs. usual care group) using Students t-test or analysis of 
variance (ANOVA) as appropriate. The correlation between change in HbA1c and changes in 
other factors such as DDS-17 score, PHQ-9 score, Diabetes Empowerment Scale Score, etc. 
will be examined using Pearson Correlation Coefficient. Where appropriate, multivariate 
analyses including general linear models will be used to further examine the relationship 
between changes in psychosocial variables and change in HbA1c, (e.g., change in depression or 
distress and relationship to change in HbA1c) while controlling for demographic characteristics 
and baseline values. In addition, based on our previous work [11], analyses examining treatment 
outcomes based on insulin use between the treatment and control groups will be conducted 
using Students t-test or repeated measures ANOVA. Furthermore, exploratory analyses, 
including multiple linear regressions, will be examined in the treatment intervention group to 
examine potential mechanisms for change across time. Missing data at follow-up associated 
with patients missing assessments will be addressed by using multiple imputations to replace 
missing values. All variables with<20% of randomly missing data will be kept and imputed. 
Multiple imputation is preferred because it is superior to other missing data approaches (i.e. 
mean replacement, last observation) and removing patients with missing data from the study 
(i.e. list-wise) which would result in a significant loss of the study sample. All analyses will be 
conducted using SPSS vs. 24 (IBM, Armonk, New York). 
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