Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
Phase: NA
Conditions: Type 1 Diabetes, Diabetes Distress
Sponsor: University of California, San Francisco

 
 
  
 
 
 
Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control (EMBARK) 
NCT04016558 
Study Protocol 
8/10/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control (EMBARK)  
Project Summary. Diabetes Distress (DD) is the personal, often hidden side of diabetes: it reﬂects the unique 
emotional burdens and strains that individuals with diabetes may experience as they struggle to keep blood 
glucose levels within range7. When high, DD can have a major, negative impact on disease management and 
glycemic control9. High DD is characterized by frustration, feeling overwhelmed, and feeling hopeless and 
discouraged by the unceasing demands of diabetes. DD is also linked to an individual’s beliefs, expectations, 
current life situation, and personal and social resources10-27.  
There have been very few systematic interventions directly aimed at reducing DD among adults with T1D. 
Furthermore, systematic reviews4,5 conclude that, of the few interventions to date, most attempt to reduce DD 
only indirectly by providing diabetes education and/or enhancing disease management. These interventions, which 
have yielded only modest improvements in HbA1c, rarely address the powerful and persistent underlying aƯective 
experience of DD, and the direct impact of high DD on disease management.  
The proposed study is a 3-arm, 12-month RCT to test the added value of a DD-targeted (TunedIn) intervention vs. a 
uniﬁed DD and management intervention (FixIt), relative to a traditional, educational/behavioral-management 
intervention (StreamLine). Each of the 3 arms will follow a separate, standardized protocol. All participants will 
receive 3 months of intervention with 9 months of subsequent follow-up (12 months total). We will examine 
models of disease-management behaviors as mediators of associations between DD and HbA1C, and explore the 
directions of longitudinal associations among DD, disease management and HbA1c.  
Aims & Hypotheses:  
Primary Speciﬁc Aim 1 Hypothesis 1. Improvement in primary (HbA1C, Diabetes Distress) and secondary 
(frequency of hypoglycemia, emotion regulation measures) outcomes from baseline to 12-month follow-up will be 
greater in TunedIn relative to StreamLine, and greater in FixIt relative to either TunedIn or StreamLine.  
Primary Speciﬁc Aim 2 Hypothesis 1 (Mediation Hypothesis). Decreases in DD will be signiﬁcantly associated 
with decreases in HbA1C within each of the 3 intervention groups over 12 months. Associations between changes 
in DD and changes in glycemic control will be explained by changes in disease-management mediators (e.g., 
increased blousing) across all 3 intervention groups. In exploratory analyses, we will examine the direction of 
associations as presented in the conceptual models in Figure 3.  
Secondary Speciﬁc Aim 1 Hypothesis 1 (Moderator Hypothesis). DiƯerences in primary and secondary 
outcomes between FixIt and TunedIn will be qualiﬁed by: (a) patient characteristics (with stronger positive eƯects 
for younger age and patients with shorter T1D duration), (b) both baseline emotion regulation (ER) skills and level of 
DD (with stronger positive eƯects for patients with poorer ER skills and higher DD), and (c) baseline cognitive-
processing constructs (with stronger positive eƯects for patients with lower problem-solving skills and diabetes 
knowledge).  
Secondary Speciﬁc Aim 2 Hypothesis 1 (Cost-eƯectiveness). FixIt and TunedIn will be more cost-eƯective than 
StreamLine in terms of improvements in primary and secondary outcomes.  
Research Design: This is a 3-arm, 12-month randomized comparison trial (baseline N=118 per arm) to test the 
added value of a DD-targeted intervention (TunedIn) vs. a uniﬁed DD and management intervention (FixIt), relative 
to a traditional, educational/behavioral-management intervention (StreamLine) to reduce diabetes distress and 
improve glycemic control in adults with type 1 diabetes. Additionally, the implementation costs and per-participant 
program costs will be calculated.  

Each of the 3 arms will follow a separate, standardized protocol. All participants will receive 3 months of 
intervention with 9 months of follow-up (12 months total).  
Background & Signiﬁcance: Diabetes distress (DD) refers to the often hidden emotional burdens, stresses, and 
worries that result from managing a demanding, progressive, chronic disease like type 1 diabetes (T1D)1. DD is 
highly prevalent (42% with elevated DD)2; is distinct from clinical depression3; tends to be chronic, rather than 
episodic2; and has been signiﬁcantly associated with poor self-care behavior and glycemic control4-8. Thus, there 
is growing evidence of associative and causative linkages among DD, self-management, and glycemic control, 
making DD a signiﬁcant clinical problem.  
There have been very few systematic interventions directly aimed at reducing DD among adults with T1D. 
Furthermore, systematic reviews by Sturt et al.4and Schmidt et al.5conclude that, of the few interventions to date, 
most attempt to reduce DD only indirectly by providing diabetes education and/or enhancing disease 
management. These interventions, which have yielded only modest improvements in HbA1C (see below), rarely 
address the powerful and persistent underlying aƯective experience of DD, and the direct impact of high DD on 
disease management. Very few address the unique, speciﬁc needs of T1D adults. Of 41 studies reviewed by Sturt 
et al., only ﬁve focused on T1D30-34, and only one included a single session on emotion-focused coping30. 
Findings indicated improvements in self-eƯicacy and empowerment, but only a 0.4% reduction in HbA1C. Schmidt 
et al. reported one additional study targeting T1D (van der Ven, 200535). This study (N=107) compared Cognitive 
Behavioral Therapy (CBT) vs. Blood Glucose Awareness Training (BGAT) (both groups attended 6, 2-hour sessions). 
The CBT group reported higher self-eƯicacy, reduced depression and anxiety symptoms, and reduced DD 
compared to BGAT, but no group diƯerences were reported in disease management or HbA1C. We found only a few 
additional studies that assessed DD or mood among T1D adults35-40. Median sample size for these studies was 
small, and all used 4-8 group-delivered or web-based CBT intervention sessions. Five of the six showed short-term 
reduced DD, but only three reported statistically signiﬁcantly improved glycemic control36-38, and even in these 
studies, improvements were modest. Only one study with a limited sample size (N=33) focused on the emotional 
side of diabetes37. Findings indicated signiﬁcantly reduced symptoms of depression and anxiety, but only a 0.3% 
reduction in HbA1C.  
In summary, (i) few studies have measured DD directly and have identiﬁed the explicit sources of DD among T1D 
adults; (ii) the content of interventions have often been focused solely on education and behavior change, with DD 
change often considered a secondary outcome; (iii) no studies have used an integrated framework that addressed 
DD-related emotions and cognitions, and none have addressed how they directly inﬂuenced diabetes 
management and glycemic control; and (iv) very few studies included T1D adults with high baseline DD and 
HbA1C, making it diƯicult to identify interventions that reduce both DD and HbA1C and determine their 
relationships. This study builds upon this literature by addressing each of these issues directly.  
Recruitment. Adults with T1D will be recruited by partnering with academic clinics’ research registries and 
community-based organizations. Partnering organizations will send e-mails and/or social media posts to their 
members. Patients who are eligible and interested during telephone screening will be emailed a link to a secure 
electronic consent and online baseline survey, with a copy of the consent emailed for their records. Patients who 
are eligible following completion will be sent a pre-paid slip to  
collect HbA1C at a local laboratory to conﬁrm HbA1C eligibility. HbA1C collection will be 5.0ml of whole  
Follow up will occur at 3, 6, and 12 months following Group Meeting 1, and procedures will be the same for each 
group. Participants will be emailed a link to a secure online follow up survey, plus a pre-paid slip to collect HbA1C 
at a local laboratory. HbA1C collection will be 5.0ml of whole blood.  

Interventions:  
1. StreamLine (management strategy)  
2. TunedIn (DD-targeted strategy)  
3. FixIt (uniﬁed strategy)  
 
Each of the 3 study arms will selectively include: (a) a group workshop (8-10 participants), (b) real-time online video 
group meetings and (c) individual phone/video calls or face-to-face meetings with the interventionist (summarized 
in Table 1).  
StreamLine (management strategy) is an education/disease management program that focuses directly on 
identifying and resolving speciﬁc BG problems; no DD-related component is included. StreamLine focuses on 
systematic methods to identify and resolve speciﬁc BG problems, primarily through changes in carbohydrate 
consumption, and basal and bolus insulin use. Participants will attend a brief, 4-hour didactic non-interactional 
meeting with a certiﬁed diabetes educator (CDE) and, using standardized BG data, will learn how to employ a 5-
point BG management system to identify and resolve BG problems (e.g., excursions, lows) that have the greatest 
HbA1C or hypoglycemia impacts: (1) utilizing BG pattern data, and (2) examining basal insulin rates, (3) frequency 
of blousing, (4) timing of bolusing, and (5) amount of insulin bolused. Participants will leave the session to record 3 
days of structured, seven-point glucose testing, ether through continuous glucose monitoring (CGM) or ﬁnger stick 
(participants' own devices; these will not be provided by the study) during the following week. They will then meet 
individually (face to face, phone/video, 30 minutes) with their CDE to review their BG data, identify a speciﬁc BG 
problem, and adjust their current management to resolve the problem, using the 5-point program. Four additional 
individual participant/facilitator meetings (face to face, phone/video, 30 minutes) will occur at approximately two 
to three-week intervals to best support individualized and participant-tailored management-change eƯorts. If 
incidicated by the facilitator and/or clinical supervisors, based on participant need, an additional one to two 
individual contacts may be scheduled during the intervention period.  
TunedIn (DD-targeted strategy) utilizes exercises and scenarios of ER-based strategies that were eƯective in 
reducing DD in the OnTrack arm of T1REDEEM6, now greatly expanded in number and focused in intensity to be 
more comprehensive and inclusive to help participants observe how what they feel aƯects what they do regarding 
disease management. Taking advantage of the power of facilitated group interaction in reducing DD, participants in 
TunedIn will attend 2 highly interactive group workshops (6 hours followed by 2 hours), facilitated by a psychologist 
or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to 
BG management (e.g., over-reacting, avoiding, lack of mindfulness). Between the two workshops (2 weeks), 
participants will  
blood. For those patients who are unable to go to a local laboratory, we will provide a HbA1C home test  
kit mailed to their home address for their convenience and comfort. After blood sample is provided by  
patient (instructions are provided in each test kit), they will mail the kit back to the lab to be analyzed.  
Randomization of eligible participants will occur after baseline assessments. Sequential ID numbers will  
be generated and randomly assigned to the 3 study groups. Each participant will receive the next ID  
number, contained in a REDCap database. Block randomization stratiﬁed by clinical recruitment site will  
be used to ensure equivalent distributions in the three intervention study arms across sites.  
complete a “feeling log,” a tool commonly used in ER-based programs, in which participants document.  
 

FixIt (uniﬁed strategy) seamlessly integrates StreamLine and TunedIn. It makes use of the same highly interactive 
group discussion around aƯect management using ER techniques and aƯect logs used in TunedIn with the same 5-
point glycemic-management program used in StreamLine. Thus, interconnected feelings and expectations are 
highlighted as problematic BG patterns are identiﬁed. To ensure the delivery of a balanced, integrated approach, 
FixIt will be co-facilitated by a psychologist/social worker experienced in diabetes (as in FixIt) and a CDE (as in 
StreamLine). Participants will attend 2 group workshops (6 hours followed by 4 hours), separated by 2 weeks. 
Between the 2 workshops, participants will record their BG data for 3 days and keep a parallel “aƯect log” to 
provide context. They will then meet face to face or through phone/video for 30 minutes with one of their 2 group 
interventionists to review the collected data and begin the process of identifying a speciﬁc glycemic problem, 
along with an action plan to address it. Full discussion of DD-related aspects of the plan will also be included to 
both enhance mindfulness and identify typical ER strategies that may reduce DD and ease problem resolution. At 
the second group session, these plans will be shared to shape the plan to make it more personally actionable. 
Participants will be further supported by: 3 online video group meetings (60 minutes, monthly) utilizing facilitated 
group discussion to review speciﬁc plans addressing behavioral and aƯective management for each participant, 
and 3 additional individual participant/facilitator meetings (face to face or phone/video, 30 minutes) to review BG 
data and the contextual and DD barriers to change. This strategy, therefore, combines the primary intervention 
modalities of StreamLine and TunedIn.  
Measures  
Telephone screening questions will document: age, years with T1D, age at diagnosis, insulin treatment (multiple-
dose injection [MDI], CGM, insulin pump), co-morbidities and diabetes-related complications, and English 
language skills (attached). Self-reported surveys completed electronically will include the following measures:  
• The number of hypoglycemic episodes will be assessed, including: frequency of symptomatic hypoglycemia 
(BG < 70 Mg/dL) in the past week and episodes of hypoglycemia in the past 6 months (or since last follow-up) 
requiring the assistance of another person or medication intervention (2 items)82.  
• The Type 1 Diabetes Distress Scale (T1DDS), an internally reliable, validated 28-item scale (alpha=.84)28 will be 
used to assess total DD plus 7 DD subscales: management, powerlessness, hypoglycemia, eating, friends/family, 
physician, and negative social perceptions.  
• Depression symptoms will be assessed using the 8-item Patient Health Questionnaire depression screener 
(PHQ-8)74,75  
• The personal ontrol subscale from the Revised Illness Perception Questionnaire (6 items; alpha=.80)87will 
assess participants’ perceived control over their illness.  
• The Five Facet Mindfulness Questionnaire88, a validated and widely used measure based on a factor analytic 
study of 5 independently developed mindfulness measures, will be used to assess: non-judging of experience, 
and nonreactivity to inner experience.  
• We also will include the only validated diabetes-speciﬁc ER scales to assess self-compassion in the context of 
diabetes management (SCS-D, 19 items; alpha=.9490). Diabetes-speciﬁc self-compassion will be measured using 
the Self-Compassion Scale - Diabetes (SCS-D) (19 items; alpha=.94)90.  
• Missed insulin boluses will be measured using self-reported numeric report of missed insulin boluses over a 7 
day period. 
 

Data Analysis. Descriptive statistics will be computed for baseline characteristics, initially testing for diƯerences 
between: (1) intervention arms and (2) patient dropouts vs. non-dropouts. Patient-level demographic and disease 
status covariates will be screened in bivariate analyses and included in multivariate analysis if they are related to 
the outcome at p< .20, signiﬁcantly diƯer between treatment arms, or are associated with dropout. Correlations 
among variables within each area of secondary outcomes and moderators (see measures above) will be examined, 
and redundant measures will be combined or eliminated to avoid multicollinearity. In the event normality 
assumptions are not met, we will use transformations to normalize distributions, ordinal or Poisson regression 
where appropriate, and/or the appropriate link function (e.g., logit link for dichotomized measures)95-97. We will 
examine change in outcomes across groups will be evaluated by ANCOVA. In these models, the follow-up value is 
speciﬁed as the outcome, the baseline value as the covariate, and treatment group was a ﬁxed eƯect. When the 
treatment group eƯect was statistically signiﬁcant (p < 0.05), Helmert contrasts will be used to determine 
diƯerences among the three groups. Missing values will be imputed with NORM software (version 2.0; The 
Methodology Center, Penn State, University Park, PA) (23,24) using multiple-imputation procedures to create a 
stable, complete data set. Parallel analyses will be performed with raw and imputed data sets. Hypothesis tests 
will be 2-sided with alpha set at .05. Goodness-of-ﬁt tests and model-ﬁtting diagnostics will be used to assess for 
inﬂuential points, outliers, over-dispersion, and heteroscedasticity, and to evaluate alternative model 
speciﬁcations.143  
Intervention implementation costs on a per-participant basis, and training costs on a per-facilitator basis, will be 
calculated using activity-based costing methods. Costs for staƯ time will be assigned based on the prevailing 
national wage rate as reported in the Bureau of Labor Statistics’ Occupational Outlook Handbook in the ﬁnal year 
of intervention implementation92. All other costs will be adjusted for inﬂation  
to constant U.S. dollars for the ﬁnal year of implementation using the Bureau of Labor Statistics’  
Sample size and power estimates are based on two-sided a = 0.05 and Student t tests on change from baseline to 
each follow-up point. Estimating a 20% attrition rate, a sample of 90 per group allows for detection of moderate 
eƯect sizes (d = 0.47 SD unit diƯerences) equating to mean changes in DD of at least 0.36 and mean changes in 
HbA1c of at least 0.44%.  
Inclusion criteria:  
To be eligible to enter baseline assessment:  
• Adult patients with T1D (conﬁrmed by clinical history and/or anti-glutamic acid decarboxylase [GAD] antibody 
testing) on intensive insulin treatment;  
• Diagnosis of T1D for at least 12 months that occurred at or below age 40;  
• Age 19 years or older;  
• Have a recent HbA1c of 7.2% or higher, or unable to recall most recent value;  
• Not have started to use any new (to the participant) diabetes device (such as an insulin pump or continuous 
glucose monitor) in the past 6 months;  
• Internet access through a computer or smart phone;  
• Ability to speak/read English.  
 
To be eligible to be randomized to receive an intervention (following baseline assessment):  

• Type 1 Diabetes Distress Scale (T1DDS) mean score 2.0 or higher;  
• HbA1c 7.5 or higher.  
 
Exclusion criteria:  
• Documented psychosis, blindness, dementia, active dialysis, substance abuse, amputations, or severe 
functional deﬁcits, or recent major surgery or hospitalization in the past year.  
 
Consent process  
During the telephone screening call, patients will be invited to give verbal consent to be screened for eligibility. 
Verbal consent will be documented by the researcher. Following determination of eligibility and interest, the study 
protocol will then be described to individuals. During the initial recruitment conversation, potential participants 
will be asked open-ended questions and they will be invited to repeat back their understanding of the study. 
Individuals will then be asked to report their name, mailing address, phone number, and email address.  
Potential participants who wish to reﬂect upon participation outside of the screening telephone call will be oƯered 
a study fact sheet that summarizes the study procedures and timescales. Potential participants will be asked for 
their email address, which will only be used to send the fact sheet to the patient. The research staƯ will agree with 
the potential participant a time to continue the telephone conversation; potential participants will also be 
encouraged to telephone the research staƯ with any questions about participation.  
Individuals eligible at the end of phone screening, and interested in participating, will be asked to give their contact 
details (including email address). A consent form will be emailed to the individual using DocuSign, which will 
indicate places where the individual should initial and sign the form. Once signed by the individual, a member of 
the research team will countersign the consent form. A copy of the signed consent will be emailed to the 
participant for their records. The consent process will additionally include a HIPAA authorization for release of 
records. As indicated on the form, these records will be  
Consumer Price Index for Medical Care.93  
limited to laboratory tests (HbA1c tests at the prescribed dates) and coming from either their electronic  
The consent will include an additional request for consent (via DocuSign) for participants' contact details to be 
stored by the research team to allow participants to be informed about future research studies.  
Risks & Beneﬁts:  
Risks are minimal. These risks, and strategies to address them, are described below.  
SURVEY ASSESSMENTS  
The survey scales used for baseline and follow up assessments are non-invasive and the emotional, social, and 
legal risks seem quite minimal; in fact the study team has used most of the assessment measures in previous 
research, including a prior, similar study, without incident. Participants will be informed during recruitment and 
consent that they may skip any questions that cause discomfort, and cease participation in the study at any time. 
The use of online survey tools will allow participants to complete assessments at a convenient time and location of 
their own choosing.  

LABORATORY ASSESSMENTS  
Although it is not feasible to utilize participants' routinely collected HbA1c results, due to incompatibility with 
survey timings, participants will be able to select a contracted community laboratory service of their choosing. 
Participant conﬁdentiality will be maintained through the use of coded blood draw requisitions that do not use any 
participant identiﬁable information. We do request obtaining consent from participants to request their current 
HbA1c result from their provider in the event that they do not complete one or more follow up blood draws.  
The blood draws that participants will be asked to undertake are equivalent to those routinely undertaken by 
patients’ as part of their ongoing diabetes care and are expected to cause minimal discomfort and risk. However, 
blood draws carry a risk of pain, bruising and fainting, and a rare risk of infection from the blood draw.  
Participant conﬁdentiality will be assured during the blood draw by the use of their unique, coded study ID as the 
sole identiﬁer on the lab slips.  
GROUP MEETINGS (IN PERSON OR WEB-BASED)  
The group meetings pose a minimal risk for breaching participant conﬁdentiality or privacy. The in-person group 
meetings will be held in a private meeting location at UCSF. Online web meetings will be held in a location of 
participants' choosing; they will be reminded to select a private location to safeguard their own and other 
attendees' privacy.  
Material covered during the meetings will be generalizable to all attendees. Before and during the group meetings 
all participants will be informed and reminded of meeting ground rules and etiquette for maintaining 
conﬁdentiality, respect and order during the meetings/  
MEDICAL ISSUES  
Although participants will not be instructed or expected to change how they manage their diabetes during the 
course of the study, they will receive education, information, and suggestions about strategies to manage blood 
sugar levels. Participants will be advised on a regular basis to review any possible changes they would like to make 
to their diabetes management regimens with their endocrinologist and/or other health care providers. In the event 
that participants report any medical concerns, for example more frequent occurrences of hypoglycemic episodes, 
they will be telephoned health records or a local laboratory (Quest diagnostics). Quest diagnostics speciﬁcally 
requires a HIPAA authorization form. The same procedure including DocuSign as outlined for the consent form 
above will be used for the HIPAA authorization form. Permission will be sought during the phone call to share the 
information with appropriate members of participants' healthcare team(s). Dr. Masharani will also be on call during 
the intervention period to address and clinical questions or concerns raised by participants or the intervention 
facilitators. 
 
DEPRESSION AND OTHER PSYCHOLOGICAL ISSUES  
Participants identiﬁed as reaching criteria for depression on the PHQ survey (a score of 15 or above) will be 
telephoned and sent a letter (see modiﬁed previously approved depression protocol, attached). This protocol 
encourages participants to seek care from a health provider for their symptoms and screens for suicide risk (which 
escalates additional referral to a senior investigator or emergency services, as required). Permission will be sought 
during the phone call to share the information with appropriate members of participants' healthcare team(s). Drs. 
Fisher and Polonsky will also be on call during the intervention period to address and questions or concerns raised 
by participants or the intervention facilitators about participants' psychological wellbeing.  

If a participant seeks help for medical or psychological issues from project staƯ, they will be referred to 
appropriate resources at their respective health care settings. A senior investigator with clinical experience will be 
on-call during participant assessments and interventions to deal with potential clinical issues that may arise.  
All study procedures are the minimum necessary to meet study objectives, with steps taken to mitigate risks. The 
research team has suƯicient expertise and experience to conduct the research, and the sample size is suƯicient to 
yield useful results.  
CONSENT  
Consent to participate is an ongoing process. During the initial recruitment conversation when the research 
assistant describes the study, they will invite participants to ask questions and ask them to repeat back to us their 
understanding of the study. Participation in the project will not aƯect the patient's clinical care in any way, and 
participants may withdraw consent at any point during their involvement.  
MEDICAL AND PSYCHOLOGICAL CONCERNS  
The protocols for addressing any emerging concerns is described above.  
CONFIDENTIALITY  
We will only collect the minimal personal information that is absolutely essential to research activity. All 
information will be coded and securely stored, with access solely granted to the investigators and study staƯ.  
ECONOMIC HARMS  
Participants will not bear the costs of any study procedures.  
BENEFITS  
Possible immediate and/or direct beneﬁts to participants and society at large include:  
• Knowledge may be gained about their health and health conditions  
• Feeling of contribution to knowledge in the health or social sciences ﬁeld  
 
Payment  
Participants will be paid for each of the 4 assessments (but not for the interventions) using gift cards on an 
incremental scale, as follows:  
Stage 
Survey 
Labs 
Total 
Baseline 
$20 
$20 
$40 
3 months 
$25 
$30 
$55 
6 months 
$30 
$35 
$65 

 
9 months 
$35 
$45 
$80 
$240