Addressing Emotional Distress to Improve Outcomes in Adults with Type 1 Diabetes: Protocol for ACT1VATE Randomized Controlled Trial

Abstract

Background:

Diabetes distress (DD) is a prevalent concern among people with type 1 diabetes (T1D) and is linked to poor clinical outcomes. Instead of targeting the elimination of DD, we propose a novel approach that empowers individuals with strategies to manage their diabetes effectively in the context of DD: Acceptance and Commitment Therapy (ACT). The purpose of this in-progress trial is to compare an ACT group intervention (ACT1VATE) with usual care in improving HbA1c, DD, quality of life, and cost-effectiveness in adults with T1D.

Methods:

This is a two-arm, parallel group, randomized controlled superiority trial enrolling N=250 adults with T1D, elevated HbA1c, and significant DD in a real-world community-based health system. Participants are randomized to receive ACT1VATE (a five-week ACT group telehealth intervention) or diabetes self-management education and support (usual care as the first-line recommended intervention for DD). The trial will examine comparative effectiveness in improving HbA1c, DD, quality of life, and cost-effectiveness over 12 months.

Discussion:

We predict that ACT1VATE will be superior given its (1) specific focus on DD, without any expectation that difficult diabetes-related thoughts and emotions must (or can) be completely eliminated; and (2) purposeful linkage of diabetes self-care behaviors to an individual’s deeply held values, thus eliciting intrinsic, patient-centric motivation for meaningful and lasting health behavior changes. This trial will provide a valuable test of real-world effectiveness, drive sustainability and scalability, and inform the future of chronic disease care.

Trial registration:

NCT04933851 (https://clinicaltrials.gov/ct2/show/NCT04933851)

Diabetes distress (DD) is the negative emotional burden individuals with diabetes experience due to living with, and managing, a demanding chronic condition (1). While related to other, broader forms of emotional distress, DD has stronger and more consistent associations with sub-optimal diabetes self-management and HbA1c (1–3). As DD is highly prevalent, with an estimated 42% of adults with type 1 diabetes (T1D) reporting clinically significant DD (4), there have been efforts to develop DD interventions to improve glycemic outcomes and quality of life for people with diabetes. The majority of approaches tested thus far are informed by cognitive behavioral therapy (CBT), which posits that negative thoughts and attitudes determine emotional state (5). CBT interventionists collaborate with patients to reduce emotional distress by directly challenging and/or refuting underlying negative beliefs. Research has not consistently supported the impact of CBT on emotional distress and clinical outcomes in diabetes—recent reviews labeled the effects of CBT-based interventions on HbA1c “elusive” (6) and/or “modest,” with mixed evidence for distress outcomes (7,8). Several large-scale RCTs have investigated approaches for addressing DD specifically (9,10). The REDEEM study compared an emotion regulation intervention versus an educational program among individuals with T1D and DD (9). Meaningful reductions in mean DD but not HbA1c were reported, and groups did not differ in DD or HbA1c change over time. Thus, CBT and other approaches designed to directly reduce distress or DD have failed to consistently improve clinical outcomes for people with diabetes (6–8,11).

Instead of targeting the elimination of DD, we propose a novel approach that empowers individuals with strategies to manage their diabetes in the context of DD: Acceptance and Commitment Therapy (ACT). ACT is a “third wave” behavioral therapy that capitalizes on the strengths and weaknesses of (traditional) CBT. Whereas CBT aims to alter or stop distressing thoughts and emotions, ACT encourages individuals to accept these experiences as they work towards their goals. ACT neither directly targets distress reduction, nor aims for complete amelioration of distress. Nonetheless, emotional distress commonly decreases in ACT as a by-product of re-engaging in life in meaningful ways, increasing acceptance of difficult internal experiences, and reducing experiential avoidance (12,13). ACT is rooted in the premise that behavioral and psychological problems are the result of experiential avoidance—i.e., attempts to change the form, frequency, or intensity of unwanted thoughts and feelings, even when doing so causes harm (14). Hence, ACT promotes psychological flexibility, or the ability to behave consistent with one’s values, even in the context of unpleasant thoughts and emotions (15). Indeed, psychological flexibility has been a driving mechanism underlying ACT’s demonstrated effectiveness in changing and maintaining a wide range of health behaviors (16). Aspects of psychological flexibility central to chronic disease management include: (1) recognizing and adapting to situational demands, (2) shifting perspective when personal or social functioning is compromised; (3) balancing competing desires, needs, and life domains, and (4) being committed to behaviors that are consistent with deeply held values (17,18). Values, or one’s judgment of what is important in life, are central to ACT and have been shown to increase persistence across multiple health behaviors (19,20). In summary, ACT increases psychological flexibility and value-based living by helping individuals attend to present-moment experiences and assume a stance of acceptance or openness towards these experiences (i.e., mindfulness (21)), such that they no longer serve as barriers to engaging in valued (health) behaviors.

Study Aims

The purpose of the in-progress ACT1VATE randomized controlled trial is to compare ACT1VATE—a novel ACT-based group psychological intervention—with usual care in improving glycemic outcomes, quality of life, and cost-effectiveness in adults with T1D, elevated HbA1c, and significant DD. The theoretical and conceptual mapping of the ACT1VATE intervention is depicted in Figure 1. By positioning the study within a real-world community-based health system, this pragmatic trial maximizes integration with routine care for T1D and generalizability of findings.

Figure 1.

ACT1VATE Theoretical Mapping.

The primary aim of this ongoing trial is to document the effectiveness of ACT1VATE versus Usual Care (UC) in improving HbA1c over 12 months in N=250 adults with T1D, significant diabetes distress, and elevated HbA1c. The second aim is to compare the effectiveness of ACT1VATE versus UC in improving diabetes self-management behavior, diabetes distress, and health-related quality of life over 12 months. The third aim is to evaluate the cost-effectiveness of ACT1VATE versus UC. Finally, although beyond the scope of the current paper, feasibility, acceptability, sustainability, and dissemination potential will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework (22,23) and reported in a forthcoming process paper.

Methods

Trial Design and Setting

This is a randomized, controlled, single-blind, parallel-groups superiority trial. This trial aims to recruit N=250 participants, allocated equally between treatment conditions (n=125 ACT1VATE, n=125 UC). Consistent with the pragmatic nature of this trial, the UC condition is implemented as the standard model of care in health care system setting in which it is taking place. The trial is conducted at Scripps Health, a large, non-profit health care system in Southern California. The trial recruits participants from across the Scripps Health system and greater San Diego community. Scripps Health provides care to over 3500 T1D adults; 40% are of ethnic/racial minority and low socioeconomic status, and the majority (71%) are of working age (18–64 years old). Recruitment began 10/2021, is ongoing (n=183 enrolled as of 08/2024) and on track to reach 100% enrollment by 06/2025. The protocol was developed in accordance with Good Clinical Practice, SPIRIT, and CONSORT 2013 guidelines. See Figure 2 for study overview.

Figure 2.

Study Overview.

Participants

Individuals who are eligible for the ACT1VATE trial must be at least 18 years old, diagnosed with T1D, a Scripps Health patient, have an HbA1c between 7.5–12.5% in the last 90 days, score ≥ 2 on the modified T1D Distress Screener (T1-DDS (24)), live in San Diego (where Scripps Health clinics/laboratories are located), and have access to technology for virtual appointments. The T1-DDS screener consists of the following subscales: Powerlessness, Management Distress, Hypoglycemia Distress, and Eating Distress. These subscales were chosen based on brevity and prior use in a similar clinical trial (25) to facilitate cross-trial comparisons.

Individuals are excluded if they have active addiction disorders, serious mental illness, or other health conditions that would interfere with the ability to participate. Patients whose medical record indicates current enrollment into another research study targeting reduction in HbA1c are excluded from enrollment to avoid concomitant diabetes interventions during participation. Concurrent research involvement is also assessed during secondary phone screening. Participants whose record indicates current or recent engagement with Scripps Health Diabetes Behavioral Health Integration Program (BeHIP) prompts an additional layer of screening prior to recruitment to avoid concomitant psychotherapy interventions: research staff consults with the BeHIP provider to assess the patient’s suitability for the study and if suitable, BeHIP treatment is postponed during the study intervention period.

Power Analysis

RMASS was used to estimate the sample size needed to detect clinically meaningful differences between groups for the primary outcome, HbA1c. Incorporating starting HbA1c levels from prior research in this population (1,26), and predicting differential HbA1c change over time of 0.5% between the two groups, we obtained a Cohen’s d=0.29. Additional assumptions included: (1) A two-sided alpha 0.05 and power 0.80; (2) 30% missingness at 12-months, and (3) a stationary autoregressive structure (lag 1) for the variance-covariance matrix of the repeated measures, using an autocorrelation of 0.50. Given these assumptions, N=250 participants are needed to detect a significant effect.

Recruitment, Enrollment, and Randomization

Research staff utilize existing, automated Epic Electronic Health Record (EHR) reports to identify potentially eligible patients. The report is run daily and includes name, medical record number, date of birth, sex, current endocrinologist or primary care provider and last encounter date, contact information, most recent HbA1c date and value, type of diabetes, and whether they have agreed to be contacted for research. Patients meeting study eligibility criteria are contacted for further screening. Patients who are not seen at Scripps Health and therefore not included in our automated EHR reports but meet all inclusion/exclusion criteria are also eligible. A study flyer is regularly distributed in local T1D community and advocacy groups to reach these patients. Research assistants contact the endocrinologist or primary care provider to offer the option to remove the patient from recruitment outreach. Patients are mailed a letter that provides a study overview and states they will receive a call with more information. A maximum of five call attempts are made before considering the patient a passive decline. In 10/2023, we introduced a $5 incentive to complete eligibility screening over the phone; anecdotally, this has improved our screening and enrollment rates. During the phone-based eligibility screening, research assistants verbally administer and score the modified T1-DDS screener. The remaining inclusion/exclusion criteria (plans to reside in San Diego region, T1D diagnosis, access to video conferencing) are also confirmed over the phone.

Patients confirmed to be eligible and interested are emailed a link to an electronic informed consent form and baseline survey. Once the consent and baseline are completed, participants are notified of their randomization status. Randomization is conducted using a random numbers generator and blind to study staff who recruit and consent patients, EHR analysts who extract outcome data, and the study statistician.

Interventions

ACT1VATE

ACT1VATE is delivered in a group telemedicine (Zoom) format in five weekly 90-minute sessions (the first group is 120-minutes). The target group size is 8–10, with a minimum of 3–4 participants per group. The three universal components of ACT interventions designed to promote psychological flexibility broadly guide the progression of ACT1VATE sessions: (1) mindfulness and acceptance of thoughts and emotions; (2) values exploration; and (3) committed action in a valued direction while experiencing thoughts and feelings. Table 1a summarizes themes and focus of each group session. The theme, content, and home practice of each session follow a structured framework, reflected in manualized slideshow presentations, in group activities, and home practice handouts.

Table 1a.

ACT1VATE Outline

Session	Theme and Content	Home Practice
Session 1	Setting the Stage: Where I am and Where I want to be Introductions, DD definition and facts, T1-DDS score review and interpretation, role of avoidance and other behavioral responses to DD, introduce mindfulness and values	Values clarification exercise
Session 2	Understanding DD and How it Can Keep You Stuck Role of cognitive fusion in DD, identifying instances when DD leads to behaviors that are inconsistent with values, defusion exercise	Practice mindfulness of cognitive and behavioral responses to DD and if consistent with values/goals, practice defusion
Session 3	Becoming Untethered: Standing Next to DD Defusion exercise, acceptance and self-compassion as alternatives to avoidance of DD, role of mindfulness, cognitive strategies for identifying more flexible responses to DD, develop and practice mindfulness and acceptance of recent DD response and alternative, compassionate response	Practice mindfulness of cognitive and behavioral responses to DD, practice acceptance of DD, develop more flexible, self-compassionate response to DD
Session 4	Making Value-based Choices Review of values, the impact of various responses to DD on values, exploring alternative responses, values as a compass, practice generating value-based responses to DD	Implement one new value-based action related to DD with willingness to feel DD
Session 5	Putting it Together Summary review and integration of material, recommendations to build on progress (maintain awareness, practice more flexible responses to DD, display visual reminders of values), tips for defusion, discussion of take-aways	N/A

Behavioral Health Provider.

The Behavioral Health Provider is a licensed professional, qualified to deliver mental health services, with experience treating patients with chronic health conditions in a medical setting. To promote sustainability after the trial, we selected a licensed Behavioral Health Provider eligible to bill for Health & Behavior CPT codes (e.g., licensed clinical psychologist or social worker). The Behavioral Health Provider must be familiar with ACT and/or the premise behind the ACT1VATE intervention components, as well as initial training and ongoing case consultation from Investigators, Fortmann and Soriano.

Personalization/Tailoring.

Despite its use of a structured framework, ACT1VATE is inherently a flexible protocol that addresses powerful influences on behavior and draws meaningful parallels between a person’s own values and the day-to-day behaviors he/she is being asked to complete for T1D. The Behavioral Health Provider is afforded flexibility in their implementation of core elements, and encouraged to tailor use of the ACT1VATE protocol to participants’: (1) root causes of DD, indicated by baseline T1-DDS subscale scores (powerlessness, social perceptions, physician-related, friend/family-related, hypoglycemia, regimen, eating (24)); (2) cultural and sociodemographic context through the sensitive consideration of values, thought patterns/beliefs, and developmental needs that influence diabetes self-management (27). First, in the first session, participants choose their own T1-DDS subscale score to focus on and explore for themselves how their avoidance keeps them further away from their values and goals. Participants share their own personal values and goals, which are used as touchstones and drivers of healthy change throughout. All interventions used are specifically designed to be agnostic to DD’s root causes and expressions/reactions, while sharing in these core elements and guiding ACT framework.

Second, to illustrate cultural tailoring in relation to the Hispanic culture—machismo refers to traditional gender role qualities expected of Hispanic men, such as having a strong work ethic and providing for his family, as well as behaviors thought to “prove” manhood (8). As enduring pain is viewed as a sign of machismo, seeing a physician may be construed as weakness. The prioritization of family over one’s own needs (familismo (7–9)), and/or the acquiescence with others’ wishes to maintain interpersonal relationships (simpatia (10,28)), suggest that making changes for one’s own health is disrespectful/socially unacceptable. These are examples of cultural factors with high potential to adversely impact individuals’ engagement in their diabetes care and management. Ignoring these influences can be detrimental to adherence yet challenging or disputing the validity of these deeply-held beliefs (i.e., consistent with CBT) is a potentially insensitive approach that may damage participant/interventionist rapport. Thus, ACT offers an ideal solution for addressing these important cultural influences. Through its focus on psychological flexibility, ACT1VATE encourages participants to consider how they respond to these thoughts, rather than evaluate or challenge their content or validity, or make attempts to change them. Importantly, ACT1VATE offers a way to accommodate cultural values that typically deter from effective diabetes management by enlisting them as intrinsic, patient-centric motivators for engagement with diabetes self-management.

Usual Care

In its inaugural Position Statement on Psychosocial Care for People with Diabetes, the American Diabetes Association identified diabetes self-management education and ongoing support (DSME/S) as the first-line intervention for DD (29). Therefore, participants assigned to UC receive standard DSME/S for adults with T1D at Scripps via in-person or video visit. At Scripps, standard DSME/S for adults with T1D is delivered in a 1:1 format by a Scripps Registered Nurse/Certified Diabetes Care and Education Specialist (RN/CDCES) and covers the American Association of Diabetes Educators AADE7 Self-Care Behaviors (30,31). Common topics are in Table 1b. DSME visits are individualized to account for between-patient variability in strengths/deficits and T1D duration. For instance, should participants report barriers to their medical regimen, the RN/CDCES will devote a portion of the visit to exploring ways to reduce burden and/or to empowering them to speak with their provider about these challenges. The RN/CDCES also assesses patients’ beliefs about diabetes and medications. Medical nutrition therapy may also be included as part of a patient’s personalized plan. The average visit is 45-minutes. The modal number of DSME/S sessions for T1D is one, but patients requiring additional education are often offered 2–4 sessions.

Table 1b.

Usual Care (DSME/S) Outline

Visit	Topics and Goals (Coverage and Order Individualized)
Visit 1	Assessment: needs/goals, diabetes self-management behaviors, technology use, recent blood glucose data, strengths/barriers to diabetes self-care, unsafe practices
Visits 1–4	Education topics: problem solving, safe practices, hypo/hyperglycemia, blood glucose goals, carb counting, carb/correction ratios, pattern management, managing glucose with exercise, support for diabetes distress, continuous glucose monitoring, insulin pumps, glucose data review, physical factors interfering with diabetes self-management, healthy coping

Assessment of Outcomes and Other Variables

Primary Outcomes

The primary outcome is HbA1c. EHR clinical data will be extracted for 12 months from enrollment. We anticipate that up to five HbA1c data points (months 0, 3, 6, 9, 12) will be available. Providers often monitor HbA1c every three months for people with T1D. For the study, participants are asked to complete a HbA1c test six and 12 months after enrollment.

Secondary Outcomes

Patient-reported outcome measures are shown in Table 2. Baseline, patient-reported outcome surveys are administered online via REDCap immediately after enrollment and prior to randomization. At months 6 and 12, research assistants email hyperlinks to complete the survey follow-ups and notify the participants by phone. Reasons for nonparticipation are noted among those who cannot be reached or decline to complete survey measures. We will examine characteristics of patients who do/do not complete these assessments so that we can describe limitations in the generalizability of these findings. Participants receive $5 for completing the eligibility screening, $45 for the baseline survey, $65 for month 6, and $75 for month 12.

Table 2.

Patient-reported Outcome Measures

Construct	Measure
General
Health-Related QOL	PROMIS Global Quality of Life (32)
Generalized Anxiety	Generalized Anxiety Disorder 7 (GAD-7) (33)
Depressive Symptoms	Patient Health Questionnaire 8 (PHQ-8) (34)
Overall QOL	World Health Organization 5 Well-being Index (WHO-5) (35)
Perceived Stress	Perceived Stress Scale (PSS) (36)
Diabetes-specific
Diabetes Self-Care	Summary of Diabetes Self-Care Activities (SDSCA) (37)
Hypoglycemia Avoidance	Hypogylcemic Attitudes & Behavior Scale (HABS) Avoidance subscale (38)
Diabetes Distress	Type 1 Diabetes Distress Scale (T1D-DDS) (24)
Hypoglycemia Anxiety	HABS Anxiety and Confidence subscales (38)
Hypoglycemia Confidence
Theoretical Mechanisms
Diabetes Knowledge	Revised Brief Diabetes Knowledge Test (DKT2) (39)
Psychological Flexibility	Acceptance & Action Diabetes Questionnaire (AADQ) (40,41)
Self-compassion	Diabetes-Specific Self Compassion Scale (ScS-D) (42)
Diabetes Support & Isolation	Diabetes Support & Isolation Questionnaire (25)

Demographic and Other Variables

Additional self-report indicators for covariate and/or exploratory purposes include: SES, nativity, marital status, and healthcare utilization. Additional clinical outcomes captured as part of routine care, medication changes, and visit history will be examined for exploratory purposes. EHR covariates including age, sex, duration of T1D, insurance, and comorbidities, will also be obtained for each participant.

Data Management and Monitoring

Staff Training

Research staff are required to complete CITI Protection of Human Subjects Training, including Good Clinical Practice and Conflict of Interest certifications, and an NIH Information Privacy and Security training, and a formal EHR training. They are trained in standardized study procedures which include questionnaire administration, recruitment procedures, consenting, and REDCap.

Electronic Health Records Abstraction

To ensure accuracy and completeness of EHR data extraction for outcome analyses, two research staff will verify 10% of the extracted data report against live EHR records to evaluate accuracy and completeness. A third staff member will perform the final validation to compile a list of data report feedback to EHR analysts.

Cohort Retention

Multiple strategies are used to maximize cohort retention. Participants email addresses, phone numbers, and mailing addresses are confirmed upon enrollment to allow for multiple methods of participant outreach throughout the study. Reminders are provided one day before and on the day of intervention appointments. Prior to the target month 6 and month 12 dates, participants are mailed a letter reminding them about the required lab work and surveys and when to expect to complete them. Subsequent reminders are provided as needed based on regular monitoring of lab and survey completion. Between scheduled study activities, there is scheduled outreach to check-in with participants and remind them about next steps in the study (months 3 and 9). Monetary compensation will be provided following each assessment.

Intervention Fidelity

Fidelity is defined as intervention dosage (number of encounters) and intended topic coverage (checklist rated). ACT1VATE dosage (session attendance) is tracked by a research assistant in the first few minutes of each session. ACT1VATE topic coverage is tracked by the Behavioral Health Provider using a checklist of key content for 10% of sessions. In UC, dosage (number of appointments) and content coverage is documented in the EHR. A research assistant will review EHR notes and complete a checklist of key content for 10% of UC appointments.

Data and Safety Monitoring Board

A Data and Safety Monitoring Plan was created and approved by the funder and IRB. The plan involved establishment of a Data Safety and Monitoring Board (DSMB) to provide oversight and external monitoring. The DSMB conducts an annual review of data on participant enrollment, procedures, data quality, retention, other measures of adherence to protocol, and adverse and serious adverse events. Investigators, project manager, and the DSMB meet annually to review reports on these data. The DSMB reviews these data and provide recommendations to the Principal Investigators regarding problems and safety concerns, recruitment process, protocols/procedures, or data quality/completeness. Adverse physical effects are expected to be minimal. Investigators will notify the DSMB of all reportable adverse events and serious adverse events as they occur. Finally, internal data monitoring procedures were established to ensure ongoing attainment of enrollment and follow-up milestones, and to track intervention fidelity over the course of the study. There are no planned stopping guidelines.

Data Analysis

Primary Outcome Analyses

For our first aim, we will analyze whether ACT1VATE significantly reduces HbA1c over time compared to UC. EHR clinical data will be extracted for 12 months from enrollment. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in HbA1c over time. Analyses will include the between-subjects factor of treatment group and the within-subjects factor of time. The baseline assessment will be specified as the referent time-point with the post-intervention and follow-up time-points, respectively, specified as the comparison time-points in the two dummy-coded predictors. The cross-level group-by-time interaction effect will be of primary interest. If a given interaction is found to be statistically significant, follow-up analyses to determine the nature of the differential change between treatment conditions. Potential covariates include age, sex, duration of T1D, insurance, and comorbidities, and follow-up multiple regression models will be conducted with these variables as fixed effects. Additional clinical outcomes captured as part of routine care (lipids, blood pressure, and body mass index), medication changes, and visit history will be examined for exploratory purposes. Each of these measures will be treated as an exploratory clinical outcome and will be analyzed following the same methods as the analyses described above for HbA1c.

Secondary Outcome Analyses

For our second aim, we will analyze change in diabetes self-management behaviors, DD, health-related quality of life, diabetes knowledge, and psychological flexibility over time. Each patient-reported outcome will be assessed by full information maximum likelihood estimation models similar to the clinical outcomes above, with the between-subjects factor of treatment group, within-subjects factor of time, and cross-level group-by-time interaction. Additional indicators that will be assessed via self-report for covariate and/or exploratory purposes include SES, nativity, duration of US residence, marital status, depressive symptoms, healthcare utilization.

Cost-effectiveness Analysis

We will evaluate the long-term cost-effectiveness of ACT1VATE versus DSME/S using a simulation model. The UKPDS Outcomes Model Risk Engine (UKPDS-OM (43)) will evaluate differential changes in life expectancy, quality-adjusted life expectancy, and lifetime costs from a health system perspective. The UKPDS-OM employs an integrated system of parametric equations to estimate the absolute risk of the first occurrence of each of seven diabetes related complications (fatal or non-fatal myocardial infarction, other ischemic heart disease, stroke, heart failure, amputation, renal failure, and eye disease) and death based on patient characteristics (e.g. age, gender) and time-varying risk factors (HbA1c, systolic BP, cholesterol, smoking status, and weight). Data from the UKPDS study was used to develop the predictive equations for diabetes-related complications, mortality, and to assign utilities conditional on disease state. Data from a large, integrated health plan were used to develop U.S. specific costs for diabetes related complications. The estimated clinical effects and costs of each study arm will be included as inputs into the UKPDS-OM simulation model. The estimated clinical effects (HbA1c change) will be derived from the study. Intervention costs will be estimated using standard accounting methods, process mapping and time-based activity costing. The base case will assume a health system perspective, 40-year time horizon, and a 3% discount rate for both Quality of Life Adjusted Years (QALYs) and costs. Sensitivity analyses will investigate the influence of the estimated treatment effects and intervention costs, the influence of the time horizon and discount rate, and second order uncertainty. The UKPSD Outcomes Model provides a full set of equation parameters that were derived from bootstrap samples of the original UKPDS population. These estimates will be used to calculate an incremental cost-effectiveness plane.

Ethics and Dissemination

The study protocol, informed consent, and materials were reviewed and approved by the Scripps Health IRB. Initial approval was obtained on 08/14/2020. All substantive modifications to the study protocol and materials as well as addition/removal of study staff are submitted to the IRB. In 01/2024, we received approval from the funding agency and IRB to modify the original HbA1c inclusion criteria from > 8% to between 7.5–12.5%. No other modifications have affected scope of work or fulfillment of study aims necessitating reporting to the funding agency.

Within 12 months of completion of follow-up data collection, results will be posted on ClinicalTrials.gov. Beyond ClinicalTrials.gov, investigators will work closely with key Stakeholders to determine optimal approaches for disseminating findings to patient, healthcare, payer, and academic communities. Patients, families, and other community members will be reached via media outlets, patient advocacy organizations, and printed information distributed at community settings. Scripps Health Public Relations teams will issue press releases to media outlets to maximize impact. Healthcare providers and administrators will be reached via organization-based email listserv and live presentations locally and nationally. Findings will be disseminated to scientific audiences via national and international conference presentations and published manuscripts.

Conclusion

Diabetes is an increasingly prevalent chronic condition that was the eighth leading cause of death in 2021 (44). Although DD is highly prevalent (4) and consistently related to self-management behavior and glycemic outcomes among people with diabetes (1–3), currently, no available interventions have been shown to significantly reduce both DD and HbA1c. This will be the first large-scale randomized trial of an ACT-based intervention specifically designed to address DD in adults with T1D and elevated HbA1c. By positioning this trial in the context of a real-world community-based health system, the ACT1VATE trial will also provide a valuable test of real-world effectiveness and enhance generalizability of findings.

Abbreviations:

DD

diabetes distress

T1D

type 1 diabetes

CBT

cognitive behavioral therapy

ACT

acceptance and commitment therapy

DSME/S

diabetes self-management education and ongoing support

UC

usual care

Data Availability

Scripps Health maintains ownership of all study data. Investigators will make deidentified data sets available upon reasonable request, pending publication of primary reports and establishment of data use agreements.