CoChat
Sign Up
Cited by 2Diabetes Management and EducationMindfulness and Compassion InterventionsDiabetes Management and Research

Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial

Open access
Soriano, Emily C., Fortmann, Addie L., Guzman, Susan J., Sandoval, Haley, Spierling Bagsic, Samantha R., Bastian, Alessandra, Antrim, McKayla, Chichmarenko, Mariya +1 more·2024·Contemporary Clinical Trials
DOI 10.1016/j.cct.2024.107687PMC PMC11531369
Open this paper in CoChat — free account

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). Clinical Trial: Clinicaltrials.gov NCT04933851 https://clinicaltrials.gov/study/NCT04933851 © 2024 Elsevier Inc.

Integrity signals

Registry

Crossref · 10.1016/j.cct.2024.107687

Cites

38 of 38 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

27 of 42 cited sources checked · 9 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    Diabetes distress has stronger and more consistent associations with sub-optimal diabetes self-management and HbA1c than other broader forms of emotional distress.

    “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).”
    Quote in the paperSubstantial claim2 of 3 sources checked
    • cites [1] source
    • cites [2] source
    • cites [3] source
  • Premisecitation

    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.

    “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).”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [12] source
    • cites [13] source

      The Discussion (page not provided) says ACT aims to help clients pursue their goals and regards symptom reduction as a by-product; it also reports better outcomes than control conditions. The Introduction describes acceptance of difficult private experiences. But the paper does not establish that emotional distress commonly decreases specifically through increased acceptance and reduced experiential avoidance; the Discussion calls for further research on the processes responsible for treatment gains. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
  • Premisecitation

    CBT and other approaches designed to directly reduce distress or diabetes distress have failed to consistently improve clinical outcomes for people with diabetes.

    “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).”
    Quote in the paperSubstantial claim4 of 4 sources checked
    • cites [6] source
    • cites [7] source

      The Abstract and Results say that treatment of depressive symptoms often fails to improve glycemic control and that no intervention type consistently benefited both mental health and A1C. But the review found a modest overall improvement in A1C, did not assess diabetes-specific distress outcomes, and used A1C rather than clinical outcomes broadly; it therefore supports a narrower claim than the citing sentence. (LLM, conf=0.82)

      Experimental — accuracy not yet measured
    • cites [8] source

      The Background reports no firm effect on blood pressure and describes the evidence as low quality, which supports the claim that clinical benefits were not consistent. But the Discussion reports improved HbA1c compared with usual care, and the review covers adults with type 2 diabetes, not all people with diabetes. The claim omits both qualifications. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [11] source

      The Discussion and Conclusions report a small improvement in glycaemic control for children and adolescents with type 1 diabetes, but no significant improvement for adults. This supports the claim that clinical benefits were not consistent. The review did not establish that the interventions were designed to directly reduce diabetes distress—its Discussion says only one study targeted people with manifest psychological problems—and it does not cover diabetes beyond type 1. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
  • Premisecitation

    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 the UKPDS study was used to develop the predictive equations for diabetes-related complications, mortality, and to assign utilities conditional on disease state.”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [43] source

      The Introduction and Derivation of risk model equations sections support that UKPDS data were used to develop equations for diabetes complications and mortality. The model—UKPDS-OM2 section says quality-of-life decrements can be calculated based on complications, but does not say UKPDS data were used to assign utilities conditional on disease state; it says details of the decrements will be reported elsewhere. Page numbers were unavailable in our copy. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
  • Premisecitation

    Currently, no available interventions have been shown to significantly reduce both diabetes distress and HbA1c.

    “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.”
    Quote in the paperSubstantial claim3 of 4 sources checked
    • cites [1] source

      The Methods describe this as a noninterventional study, and the Conclusions call for developing interventions for distressed patients. The discussion of intervention trials concerns depression, not diabetes distress. Our copy does not establish whether any available intervention had significantly reduced both diabetes distress and HbA1c (pages not supplied). (LLM, conf=0.76)

      Experimental — accuracy not yet measured
    • cites [2] source
    • cites [3] source

      The Conclusion reports behavioural programmes that reduced diabetes distress and says decreases in distress were associated with improved glycaemic control. It does not say whether any intervention significantly reduced both distress and HbA1c, so it cannot establish the claim that none had done so. The paper’s own Results describe associations over time, not an intervention test; the citation in the printed sentence appears beside the association claim rather than the intervention claim. No page number is available in our copy. (LLM, conf=0.76)

      Experimental — accuracy not yet measured
    • cites [4] source
  • May combine two claims. 12
  • Classified as probably not a substantial claim. 20

  • May combine two claims.

    Premisecitation

    Research has not consistently supported the impact of CBT on emotional distress and clinical outcomes in diabetes; reviews label HbA1c effects as elusive or modest, with mixed evidence for distress outcomes.

    “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).”
    Quote in the paperSubstantial claim1 of 3 sources checked
    • cites [6]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [7] source

      The Results (page unavailable) report a modest improvement in A1C from psychosocial interventions and a smaller improvement in mental health, with little association between the two effects. CBT was among the interventions reviewed, but the paper does not establish these findings specifically for CBT or describe the overall evidence for distress outcomes as mixed. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [8]

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    An estimated 42% of adults with type 1 diabetes report clinically significant diabetes distress.

    “As DD is highly prevalent, with an estimated 42% of adults with type 1 diabetes (T1D) reporting clinically significant DD (4)”
    Quote in the paperNot a substantial claim1 of 1 sources checked

  • May combine two claims.

    Premisecitation

    Diabetes distress is prevalent among adults with type 1 diabetes and is associated with poor clinical outcomes.

    “Diabetes distress (DD) is a prevalent concern among people with type 1 diabetes (T1D) and is linked to poor clinical outcomes.”
    • Also stated in: § Conclusion · boosted
      “Although DD is highly prevalent (4) and consistently related to self-management behavior and glycemic outcomes among people with diabetes (1–3)”
    Quote in the paperSubstantial claim3 of 4 sources checked
    • cites [1] source

      The Abstract Conclusions report an association between diabetes distress and A1C, and the Conclusions describe distress as relatively common and associated with diabetes-related variables. But the Abstract Research Design and Methods specifies that the study assessed 506 people with type 2 diabetes; it does not establish prevalence or clinical-outcome associations among people with type 1 diabetes. Page numbers are not available in our copy. (LLM, conf=0.90)

      Experimental — accuracy not yet measured
    • cites [2] source
    • cites [3] source

      The Results (Abstract; page not provided) link greater diabetes distress in adults with type 1 diabetes to higher HbA1c and more missed insulin boluses. The passages establish an association with poorer outcomes but do not establish that diabetes distress is prevalent among this population; a search for prevalence found no supporting statement. (LLM, conf=0.82)

      Experimental — accuracy not yet measured
    • cites [4] source

  • Classified as probably not a substantial claim.

    Premisecitation

    The UKPDS Outcomes Model Risk Engine estimates the absolute risk of first occurrence of seven diabetes-related complications and death based on patient characteristics and time-varying risk factors.

    “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”
    Quote in the paperSubstantial claim1 of 1 sources checked
    • cites [43] source

      The Model—UKPDS-OM2 section says the model uses patient characteristics and clinical risk factors to calculate probabilities of complications and death, and the Derivation of risk model equations section identifies time-varying risk factors. But this paper describes UKPDS-OM2 as having eight complication equations, including diabetic ulcer, rather than only seven; the Introduction identifies seven as the number in the original model. The paper also specifies blindness rather than eye disease generally. (LLM, conf=0.88)

      Experimental — accuracy not yet measured

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    Aspects of psychological flexibility central to chronic disease management include recognizing and adapting to situational demands, shifting perspective when personal or social functioning is compromised, balancing competing desires, needs, and life domains, and being committed to behaviors consistent with deeply held values.

    “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).”
    Quote in the paperSubstantial claim2 of 2 sources checked
    • cites [17] source

      The Abstract and opening section describe the four listed aspects of psychological flexibility, including adapting to situational demands, shifting responses, balancing life domains, and acting in line with values. The paper discusses psychological health broadly, but does not establish that these aspects are central specifically to chronic disease management. Page numbers are unavailable in our copy. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
    • cites [18] source

      In Results, Theme 4 (Resources), the review describes adjusting goals when resources change or functioning is lost; Theme 2 (Self-regulation) discusses responding to competing desires and contextual demands. These passages support parts of the list, but the paper does not present the four items as aspects of psychological flexibility central to chronic disease management, or specifically describe commitment to behaviors consistent with deeply held values. Page numbers were not available in our copy. (LLM, conf=0.83)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The American Diabetes Association identified diabetes self-management education and ongoing support as the first-line intervention for diabetes distress.

    “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).”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [29] source

      The Diabetes Distress section recommends referral for tailored diabetes education when distress is identified, followed by behavioral-health referral if self-care remains impaired. This supports education as an initial step, but the passage does not identify ongoing support (DSME/S) as part of that first-line intervention. (LLM, conf=0.85)

      Experimental — accuracy not yet measured

  • Classified as probably not a substantial claim.

    Premisecitation

    ACT promotes psychological flexibility, the ability to behave consistent with one's values even in the context of unpleasant thoughts and emotions.

    “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).”
    Quote in the paperSubstantial claim1 of 1 sources checked

  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given

    This will be the first large-scale randomized trial of an ACT-based intervention specifically designed to address diabetes distress in adults with type 1 diabetes and elevated 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.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    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.

    “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.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Values are central to ACT and have been shown to increase persistence across multiple health behaviors.

    “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).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [19] source
    • cites [20] source

  • Probably not a substantial claim: may not pass S4 (based).

    Interpretationnone given

    Positioning the study within a real-world community-based health system maximizes integration with routine care for type 1 diabetes and generalizability of findings.

    “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.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationreasoning

    Ignoring cultural influences can be detrimental to adherence, yet challenging or disputing the validity of these deeply-held beliefs is a potentially insensitive approach that may damage participant/interventionist rapport.

    “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.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    The modified T1-DDS screener subscales were chosen based on brevity and prior use in a similar clinical trial to facilitate cross-trial comparisons.

    “These subscales were chosen based on brevity and prior use in a similar clinical trial (25) to facilitate cross-trial comparisons.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [25] source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The study protocol, informed consent, and materials were reviewed and approved by the Scripps Health IRB.

    “The study protocol, informed consent, and materials were reviewed and approved by the Scripps Health IRB.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The protocol was developed in accordance with Good Clinical Practice, SPIRIT, and CONSORT 2013 guidelines.

    “The protocol was developed in accordance with Good Clinical Practice, SPIRIT, and CONSORT 2013 guidelines.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    Randomization is conducted using a random numbers generator and is blind to study staff who recruit and consent patients, EHR analysts who extract outcome data, and the study statistician.

    “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.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    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.

    “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.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    The trial is a randomized, controlled, single-blind, parallel-groups superiority trial.

    “This is a randomized, controlled, single-blind, parallel-groups superiority trial.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    Intervention fidelity is defined as intervention dosage and intended topic coverage, and is tracked for ACT1VATE and usual care.

    “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”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.

    Interpretationnone given

    Positioning this trial in a real-world community-based health system will provide a valuable test of real-world effectiveness and enhance generalizability of findings.

    “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.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning

    Multiple strategies are used to maximize cohort retention, including confirming contact information, reminders, and monetary compensation.

    “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.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    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, and a third staff member will perform final validation.

    “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.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    RMASS was used to estimate the sample size needed to detect clinically meaningful differences between groups for the primary outcome, HbA1c.

    “RMASS was used to estimate the sample size needed to detect clinically meaningful differences between groups for the primary outcome, HbA1c.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    A Data and Safety Monitoring Plan was created and approved by the funder and IRB, establishing a Data Safety and Monitoring Board to provide oversight and external monitoring.

    “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.”
    Quote in the paperNot a substantial claim
24 of 24

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Eligibility for people outside Scripps Health is unclear

    Major

    The eligibility criteria require participants to be Scripps Health patients, but the recruitment section also says people not seen at Scripps Health can be eligible. The text does not explain how those people would satisfy the patient requirement.

1 of 1

Cites

Flagged first, then by citations

2 of the 40 references couldn’t be matched to a known paper.

Research works printed but not linked: 1

  1. 2018, Summary of Revisions: Standards of medical care in diabetes-2018, Diabetes Care, 41, 29222371

Cited by

Sorted by citations

Related

Authors
Soriano, E. C., Fortmann, A. L., Guzman, S. J., Sandoval, H., Spierling Bagsic, S. R., Bastian, A., Antrim, M., Chichmarenko, M., & Philis-Tsimikas, A.
Affiliations
  • Scripps Health (US)
  • Drexel University (US)
Corresponding author
Soriano, Emily C.
ORCID
Venue
Contemporary Clinical Trials
Publisher
Elsevier BV
Published
2024-11
Volume
146
Pages
107687
ISSN
1551-7144 (ISSN-L)
DOI
10.1016/j.cct.2024.107687
PMC
PMC11531369
OpenAlex
W4402519469
Cited by
2
References
40
Citations by year
2025: 1 · 2024: 1
FWCI
0.49
Type
journal article
Language
en
Open access
Licence
Locations
  • Contemporary Clinical Trials (acceptedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (submittedVersion)
  • PubMed Central (submittedVersion)
Funders
National Institute of Diabetes and Digestive and Kidney Diseases
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
type 1 diabetes, diabetes distress, acceptance and commitment therapy, telehealth intervention, group intervention, HbA1c, glycemic control, quality of life
MeSH terms
Self-Management, Equivalence Trials as Topic, Psychological Distress, Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read under definition version 3 (extract-v3) on 2026-09-28.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-09-28.

Cited sources are checked by gpt-6-sol.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review