Clinical trial NCT05734313: Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression
Official title: Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression in Young Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Type 1 Diabetes
Keywords: Diabetes
Type 1 Diabetes
Depression
Anxiety
Diabetes Distress
Diabetes Management
Diabetes Self-Care
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: DexCom, Inc.
First posted: 2023-02-17
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two arms in this trial, (1) The Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) Intervention Arm paired with use of continuous glucose monitor (CGM) and (2) CGM only. The active comparison condition of CGM only allows for the evaluation of whether directly targeting emotional disorders with UP-CBT adds value beyond the state-of-the-art approach to glycemic management in Type 1 Diabetes. To the extent that the relationship between emotional disorders and diabetes is bidirectional, a common assumption across research studies in this area, the comparison condition should benefit anxiety and depression outcomes through improved glycemic control and diabetes self-management.
Primary purpose: TREATMENT

Brief summary: This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in adults with type 1 diabetes.

Detailed description: The efficacy of the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) combined with commercial FDA-approved Continuous Glucose Monitoring (CGM) will be tested in comparison to CGM only in a randomized controlled clinical trial. The central hypothesis is that the addition of the UP-CBT intervention will yield clinically significant improvements in anxiety and depressive symptom severity and glycemic control relative to CGM alone. We will recruit 94 adults (age 18-64) with suboptimally controlled type 1 diabetes and an anxiety or depressive disorder from a national population for an entirely virtual 12-month study over five years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of hemoglobin A1c (HbA1c) for glycemic control and validated patient-reported outcome (PRO) surveys, the study integrates momentary psychological and behavioral data via smartphone-based ecological momentary assessment (EMA) with CGM data to assess day-to-day changes in affect, self-management, and glycemia over the course of the trial.

Qualitative information will be collected from people with Type 1 Diabetes (T1D) ages 35-64 to solicit suggestions and inform future study decisions. We will create 2-4 focus groups to ask their impressions about our current study and to explore key factors like establishing adult care and attending medical appointments, disease self-management, and adjusting to chronic disease. We will compare interview responses from participant groups who have high vs. low social needs and poor vs. good glycemic control.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes (T1D) duration ≥ 6 months
* 18-64 years old
* HbA1c = 7.5-14%
* English- or Spanish-speaking
* Anxiety or depressive mood disorder as per structured diagnostic interview.

Exclusion Criteria:

* Developmental or sensory disability interfering with participation
* Current pregnancy
* Bipolar disorders, psychotic disorders, severe eating disorders, severe substance abuse disorders, or acute suicidal risk or self-harm
* Use of medications or recent medical procedures that would impact glycemic control or use of continuous glucose monitoring (CGM) over the study
* Received cognitive behavioral therapy (CBT) in last year or plans to initiate CBT; (6) temporary exclusion for recent initiation of psychotropic medication - must be on a stable dose for 6 weeks prior to enrollment.

Primary outcomes:
measure: Anxiety symptom severity
timeFrame: 6 months
measure: Depressive symptom severity
timeFrame: 6 months
Secondary outcomes:
measure: Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)
timeFrame: 6 months
measure: Hemoglobin A1c (HbA1c)
timeFrame: 6 months
Other outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: 9 months
measure: Hemoglobin A1c (HbA1c)
timeFrame: 12 months
measure: Depressive symptom severity
timeFrame: 9 months
measure: Depressive symptom severity
timeFrame: 12 months
measure: Anxiety symptom severity
timeFrame: 9 months
measure: Anxiety symptom severity
timeFrame: 12 months
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Jeffrey Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young-Hyman D, de Groot M, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Psychosocial Care for People With Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Dec;39(12):2126-2140. doi: 10.2337/dc16-2053. No abstract available.
citation: Gonzalez JS, Hood KK, Esbitt SA, Mukherji S, Kane NS, Jacobson A. Psychiatric and Psychosocial Issues Among Individuals Living With Diabetes. In: Cowie CC, Casagrande SS, Menke A, Cissell MA, Eberhardt MS, Meigs JB, Gregg EW, Knowler WC, Barrett-Connor E, Becker DJ, Brancati FL, Boyko EJ, Herman WH, Howard BV, Narayan KMV, Rewers M, Fradkin JE, editors. Diabetes in America. 3rd edition. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases (US); 2018 Aug. CHAPTER 33. Available from http://www.ncbi.nlm.nih.gov/books/NBK567974/
citation: American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). 2013.
citation: Ellard KK, Fairholme CP, Boisseau CL, Farchione TJ, Barlow DH. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: Protocol Development and Initial Outcome Data. Cogn Behav Pract. 2010 Feb;17(1):88-101. doi: 10.1016/j.cbpra.2009.06.002. Epub 2010 Jan 29.
citation: Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.
citation: Sakiris N, Berle D. A systematic review and meta-analysis of the Unified Protocol as a transdiagnostic emotion regulation based intervention. Clin Psychol Rev. 2019 Aug;72:101751. doi: 10.1016/j.cpr.2019.101751. Epub 2019 Jun 25.
citation: Steele SJ, Farchione TJ, Cassiello-Robbins C, Ametaj A, Sbi S, Sauer-Zavala S, Barlow DH. Efficacy of the Unified Protocol for transdiagnostic treatment of comorbid psychopathology accompanying emotional disorders compared to treatments targeting single disorders. J Psychiatr Res. 2018 Sep;104:211-216. doi: 10.1016/j.jpsychires.2018.08.005. Epub 2018 Aug 3.
citation: Cassiello-Robbins C, Southward MW, Tirpak JW, Sauer-Zavala S. A systematic review of Unified Protocol applications with adult populations: Facilitating widespread dissemination via adaptability. Clin Psychol Rev. 2020 Jun;78:101852. doi: 10.1016/j.cpr.2020.101852. Epub 2020 Apr 20.
citation: Carlucci L, Saggino A, Balsamo M. On the efficacy of the unified protocol for transdiagnostic treatment of emotional disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Jul;87:101999. doi: 10.1016/j.cpr.2021.101999. Epub 2021 Mar 9.
citation: Peters A, Laffel L; American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by the American College of Osteopathic Family Physicians, the American Academy of Pediatrics, the American Association of Clinical Endocrinologists, the American Osteopathic Association, the Centers for Disease Control and Prevention, Children with Diabetes, The Endocrine Society, the International Society for Pediatric and Adolescent Diabetes, Juvenile Diabetes Research Foundation International, the National Diabetes Education Program, and the Pediatric Endocrine Society (formerly Lawson Wilkins Pediatric Endocrine Society). Diabetes Care. 2011 Nov;34(11):2477-85. doi: 10.2337/dc11-1723. No abstract available.
citation: Srinivas P, Bodke K, Ofner S, Keith NR, Tu W, Clark DO. Context-Sensitive Ecological Momentary Assessment: Application of User-Centered Design for Improving User Satisfaction and Engagement During Self-Report. JMIR Mhealth Uhealth. 2019 Apr 3;7(4):e10894. doi: 10.2196/10894.
citation: Yang YS, Ryu GW, Choi M. Methodological Strategies for Ecological Momentary Assessment to Evaluate Mood and Stress in Adult Patients Using Mobile Phones: Systematic Review. JMIR Mhealth Uhealth. 2019 Apr 1;7(4):e11215. doi: 10.2196/11215.
citation: Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.
citation: Livingstone SJ, Levin D, Looker HC, Lindsay RS, Wild SH, Joss N, Leese G, Leslie P, McCrimmon RJ, Metcalfe W, McKnight JA, Morris AD, Pearson DW, Petrie JR, Philip S, Sattar NA, Traynor JP, Colhoun HM; Scottish Diabetes Research Network epidemiology group; Scottish Renal Registry. Estimated life expectancy in a Scottish cohort with type 1 diabetes, 2008-2010. JAMA. 2015 Jan 6;313(1):37-44. doi: 10.1001/jama.2014.16425.
citation: Rhodes ET, Prosser LA, Hoerger TJ, Lieu T, Ludwig DS, Laffel LM. Estimated morbidity and mortality in adolescents and young adults diagnosed with Type 2 diabetes mellitus. Diabet Med. 2012 Apr;29(4):453-63. doi: 10.1111/j.1464-5491.2011.03542.x.
citation: Dabelea D, Stafford JM, Mayer-Davis EJ, D'Agostino R Jr, Dolan L, Imperatore G, Linder B, Lawrence JM, Marcovina SM, Mottl AK, Black MH, Pop-Busui R, Saydah S, Hamman RF, Pihoker C; SEARCH for Diabetes in Youth Research Group. Association of Type 1 Diabetes vs Type 2 Diabetes Diagnosed During Childhood and Adolescence With Complications During Teenage Years and Young Adulthood. JAMA. 2017 Feb 28;317(8):825-835. doi: 10.1001/jama.2017.0686.
citation: Bryden KS, Peveler RC, Stein A, Neil A, Mayou RA, Dunger DB. Clinical and psychological course of diabetes from adolescence to young adulthood: a longitudinal cohort study. Diabetes Care. 2001 Sep;24(9):1536-40. doi: 10.2337/diacare.24.9.1536.
citation: Rodwell L, Romaniuk H, Nilsen W, Carlin JB, Lee KJ, Patton GC. Adolescent mental health and behavioural predictors of being NEET: a prospective study of young adults not in employment, education, or training. Psychol Med. 2018 Apr;48(5):861-871. doi: 10.1017/S0033291717002434. Epub 2017 Sep 6.
citation: 2014 Diabetes Health Care Cost Institute Utilization Report. Health Care Cost Institute. Published 2014. Accessed October 3, 2021. https://healthcostinstitute.org/images/easyblog_articles/276/HCCI-2017-Health-Care-Cost-and-Utilization-Report-02.12.19.pdf
citation: Sequeira PA, Pyatak EA, Weigensberg MJ, Vigen CP, Wood JR, Ruelas V, Montoya L, Cohen M, Speer H, Clark S, Peters AL. Let's Empower and Prepare (LEAP): Evaluation of a Structured Transition Program for Young Adults With Type 1 Diabetes. Diabetes Care. 2015 Aug;38(8):1412-9. doi: 10.2337/dc14-2577. Epub 2015 Apr 23.
citation: Pyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19.
citation: Bakhach M, Reid MW, Pyatak EA, Berget C, Cain C, Thomas JF, Klingensmith GJ, Raymond JK. Home Telemedicine (CoYoT1 Clinic): A Novel Approach to Improve Psychosocial Outcomes in Young Adults With Diabetes. Diabetes Educ. 2019 Aug;45(4):420-430. doi: 10.1177/0145721719858080. Epub 2019 Jun 27.
citation: Kessler RC, Ruscio AM, Shear K, Wittchen HU. Epidemiology of anxiety disorders. Curr Top Behav Neurosci. 2010;2:21-35.
citation: Zimmerman M, Clark HL, Multach MD, Walsh E, Rosenstein LK, Gazarian D. Have Treatment Studies of Depression Become Even Less Generalizable? A Review of the Inclusion and Exclusion Criteria Used in Placebo-Controlled Antidepressant Efficacy Trials Published During the Past 20 Years. Mayo Clin Proc. 2015 Sep;90(9):1180-6. doi: 10.1016/j.mayocp.2015.06.016. Epub 2015 Aug 12.
citation: Lorenzo-Luaces L, Zimmerman M, Cuijpers P. Are studies of psychotherapies for depression more or less generalizable than studies of antidepressants? J Affect Disord. 2018 Jul;234:8-13. doi: 10.1016/j.jad.2018.02.066. Epub 2018 Feb 27.
citation: Simoni JM, Wiebe JS, Sauceda JA, Huh D, Sanchez G, Longoria V, Andres Bedoya C, Safren SA. A preliminary RCT of CBT-AD for adherence and depression among HIV-positive Latinos on the U.S.-Mexico border: the Nuevo Dia study. AIDS Behav. 2013 Oct;17(8):2816-29. doi: 10.1007/s10461-013-0538-5.
citation: Allen LB, White KS, Barlow DH, Shear MK, Gorman JM, Woods SW. Cognitive-Behavior Therapy (CBT) for Panic Disorder: Relationship of Anxiety and Depression Comorbidity with Treatment Outcome. J Psychopathol Behav Assess. 2010 Jun;32(2):185-192. doi: 10.1007/s10862-009-9151-3. Epub 2009 Jul 24.
citation: Tsao JC, Lewin MR, Craske MG. The effects of cognitive-behavior therapy for panic disorder on comorbid conditions. J Anxiety Disord. 1998 Jul-Aug;12(4):357-71. doi: 10.1016/s0887-6185(98)00020-6.
citation: Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
citation: Gonzalez JS, McCarl LA, Wexler D DD, Cagliero E, Delahanty L, Soper TD, Goldman V, Knauz R, Safren SA. Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in Type 2 Diabetes. J Cogn Psychother. 2010 Nov 1;24(4):329-343. doi: 10.1891/0889-8391.24.4.329.
citation: Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty LM, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes. Diabetes Care. 2014;37(3):625-33. doi: 10.2337/dc13-0816. Epub 2013 Oct 29.
citation: Targum SD, Sauder C, Evans M, Saber JN, Harvey PD. Ecological momentary assessment as a measurement tool in depression trials. J Psychiatr Res. 2021 Apr;136:256-264. doi: 10.1016/j.jpsychires.2021.02.012. Epub 2021 Feb 14.
citation: Mulvaney SA, Vaala SE, Carroll RB, Williams LK, Lybarger CK, Schmidt DC, Dietrich MS, Laffel LM, Hood KK. A mobile app identifies momentary psychosocial and contextual factors related to mealtime self-management in adolescents with type 1 diabetes. J Am Med Inform Assoc. 2019 Dec 1;26(12):1627-1631. doi: 10.1093/jamia/ocz147.
citation: Hermanns N, Scheff C, Kulzer B, Weyers P, Pauli P, Kubiak T, Haak T. Association of glucose levels and glucose variability with mood in type 1 diabetic patients. Diabetologia. 2007 May;50(5):930-3. doi: 10.1007/s00125-007-0643-y. Epub 2007 Mar 17.
citation: Wagner J, Armeli S, Tennen H, Bermudez-Millan A, Wolpert H, Perez-Escamilla R. A daily study of stressors, continuously measured glucose, and diabetes symptoms in latinos with type 2 diabetes. J Behav Med. 2021 Feb;44(1):94-103. doi: 10.1007/s10865-020-00162-1. Epub 2020 Jun 3.
citation: Skaff MM, Mullan JT, Almeida DM, Hoffman L, Masharani U, Mohr D, Fisher L. Daily negative mood affects fasting glucose in type 2 diabetes. Health Psychol. 2009 May;28(3):265-72. doi: 10.1037/a0014429.
citation: Polonsky WH, Fortmann AL. The influence of time in range on daily mood in adults with type 1 diabetes. J Diabetes Complications. 2020 Dec;34(12):107746. doi: 10.1016/j.jdiacomp.2020.107746. Epub 2020 Oct 7.
citation: Bullis JR, Fortune MR, Farchione TJ, Barlow DH. A preliminary investigation of the long-term outcome of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Compr Psychiatry. 2014 Nov;55(8):1920-7. doi: 10.1016/j.comppsych.2014.07.016. Epub 2014 Jul 22.
citation: Markowitz SM, Carper MM, Gonzalez JS, Delahanty LM, Safren SA. Cognitive-behavioral therapy for the treatment of depression and adherence in patients with type 1 diabetes: pilot data and feasibility. Prim Care Companion CNS Disord. 2012;14(2):PCC.11m01220. doi: 10.4088/PCC.11m01220. Epub 2012 Mar 15.
citation: Esbitt SA, Batchelder AW, Tanenbaum ML, Shreck E, Gonzalez JS. "Knowing That You're Not the Only One": Perspectives on Group-Based Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) in Adults With Type 1 Diabetes. Cogn Behav Pract. 2015 Aug 1;22(3):393-406. doi: 10.1016/j.cbpra.2014.02.006.
citation: Agarwal S, Kanapka LG, Raymond JK, Walker A, Gerard-Gonzalez A, Kruger D, Redondo MJ, Rickels MR, Shah VN, Butler A, Gonzalez J, Verdejo AS, Gal RL, Willi S, Long JA. Racial-Ethnic Inequity in Young Adults With Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Aug 1;105(8):e2960-9. doi: 10.1210/clinem/dgaa236.
citation: Agarwal S, Schechter C, Gonzalez J, Long JA. Racial-Ethnic Disparities in Diabetes Technology use Among Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Apr;23(4):306-313. doi: 10.1089/dia.2020.0338. Epub 2020 Dec 1.
citation: Agarwal S, Raymond JK, Schutta MH, Cardillo S, Miller VA, Long JA. An Adult Health Care-Based Pediatric to Adult Transition Program for Emerging Adults With Type 1 Diabetes. Diabetes Educ. 2017 Feb;43(1):87-96. doi: 10.1177/0145721716677098. Epub 2016 Nov 15.
citation: Agarwal S, Hilliard M, Butler A. Disparities in Care Delivery and Outcomes in Young Adults With Diabetes. Curr Diab Rep. 2018 Jul 14;18(9):65. doi: 10.1007/s11892-018-1037-x.
citation: Agarwal S, Cappola AR. Continuous Glucose Monitoring in Adolescent, Young Adult, and Older Patients With Type 1 Diabetes. JAMA. 2020 Jun 16;323(23):2384-2385. doi: 10.1001/jama.2020.7058. No abstract available.
citation: Garvey KC, Foster NC, Agarwal S, DiMeglio LA, Anderson BJ, Corathers SD, Desimone ME, Libman IM, Lyons SK, Peters AL, Raymond JK, Laffel LM. Health Care Transition Preparation and Experiences in a U.S. National Sample of Young Adults With Type 1 Diabetes. Diabetes Care. 2017 Mar;40(3):317-324. doi: 10.2337/dc16-1729. Epub 2016 Dec 22.
citation: Kahkoska AR, Shay CM, Crandell J, Dabelea D, Imperatore G, Lawrence JM, Liese AD, Pihoker C, Reboussin BA, Agarwal S, Tooze JA, Wagenknecht LE, Zhong VW, Mayer-Davis EJ. Association of Race and Ethnicity With Glycemic Control and Hemoglobin A1c Levels in Youth With Type 1 Diabetes. JAMA Netw Open. 2018 Sep 7;1(5):e181851. doi: 10.1001/jamanetworkopen.2018.1851.
citation: Agarwal S, Jawad AF, Miller VA. A multivariate model exploring the predictive value of demographic, adolescent, and family factors on glycemic control in adolescents with type 1 diabetes. Pediatr Diabetes. 2016 Nov;17(7):500-508. doi: 10.1111/pedi.12331. Epub 2015 Oct 21.
citation: Ehrenreich-May J, Rosenfield D, Queen AH, Kennedy SM, Remmes CS, Barlow DH. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents. J Anxiety Disord. 2017 Mar;46:46-55. doi: 10.1016/j.janxdis.2016.10.006. Epub 2016 Oct 17.
citation: Sauer-Zavala S, Boswell JF, Gallagher MW, Bentley KH, Ametaj A, Barlow DH. The role of negative affectivity and negative reactivity to emotions in predicting outcomes in the unified protocol for the transdiagnostic treatment of emotional disorders. Behav Res Ther. 2012 Sep;50(9):551-7. doi: 10.1016/j.brat.2012.05.005. Epub 2012 Jun 9.
citation: Boswell JF, Farchione TJ, Sauer-Zavala S, Murray HW, Fortune MR, Barlow DH. Anxiety sensitivity and interoceptive exposure: a transdiagnostic construct and change strategy. Behav Ther. 2013 Sep;44(3):417-31. doi: 10.1016/j.beth.2013.03.006. Epub 2013 Apr 2.
citation: Mohr DC, Ho J, Duffecy J, Reifler D, Sokol L, Burns MN, Jin L, Siddique J. Effect of telephone-administered vs face-to-face cognitive behavioral therapy on adherence to therapy and depression outcomes among primary care patients: a randomized trial. JAMA. 2012 Jun 6;307(21):2278-85. doi: 10.1001/jama.2012.5588.
citation: Raymond JK, Berget CL, Driscoll KA, Ketchum K, Cain C, Fred Thomas JF. CoYoT1 Clinic: Innovative Telemedicine Care Model for Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2016 Jun;18(6):385-90. doi: 10.1089/dia.2015.0425. Epub 2016 May 19.
citation: Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
citation: Shear MK, Vander Bilt J, Rucci P, Endicott J, Lydiard B, Otto MW, Pollack MH, Chandler L, Williams J, Ali A, Frank DM. Reliability and validity of a structured interview guide for the Hamilton Anxiety Rating Scale (SIGH-A). Depress Anxiety. 2001;13(4):166-78.
citation: Williams J, Link M, Rosenthal N, Terman M. Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD). New York: New York State Psychiatric Institute.1988.
citation: Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
citation: Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.
citation: Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: Perera MJ, Brintz CE, Birnbaum-Weitzman O, Penedo FJ, Gallo LC, Gonzalez P, Gouskova N, Isasi CR, Navas-Nacher EL, Perreira KM, Roesch SC, Schneiderman N, Llabre MM. Factor structure of the Perceived Stress Scale-10 (PSS) across English and Spanish language responders in the HCHS/SOL Sociocultural Ancillary Study. Psychol Assess. 2017 Mar;29(3):320-328. doi: 10.1037/pas0000336. Epub 2016 Jun 9.
citation: Geddes J, Wright RJ, Zammitt NN, Deary IJ, Frier BM. An evaluation of methods of assessing impaired awareness of hypoglycemia in type 1 diabetes. Diabetes Care. 2007 Jul;30(7):1868-70. doi: 10.2337/dc06-2556. Epub 2007 Apr 6. No abstract available.
citation: Gonder-Frederick LA, Schmidt KM, Vajda KA, Greear ML, Singh H, Shepard JA, Cox DJ. Psychometric properties of the hypoglycemia fear survey-ii for adults with type 1 diabetes. Diabetes Care. 2011 Apr;34(4):801-6. doi: 10.2337/dc10-1343. Epub 2011 Feb 23.
citation: Manzar MD, BaHammam AS, Hameed UA, Spence DW, Pandi-Perumal SR, Moscovitch A, Streiner DL. Dimensionality of the Pittsburgh Sleep Quality Index: a systematic review. Health Qual Life Outcomes. 2018 May 9;16(1):89. doi: 10.1186/s12955-018-0915-x.
citation: Laffel LM, Kanapka LG, Beck RW, Bergamo K, Clements MA, Criego A, DeSalvo DJ, Goland R, Hood K, Liljenquist D, Messer LH, Monzavi R, Mouse TJ, Prahalad P, Sherr J, Simmons JH, Wadwa RP, Weinstock RS, Willi SM, Miller KM; CGM Intervention in Teens and Young Adults with T1D (CITY) Study Group; CDE10. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2388-2396. doi: 10.1001/jama.2020.6940.
citation: Snijders T BR. Multilevel Modeling: An Introduction to Basic and Advanced Multilevel Modeling. Sage Publications; 1999.
citation: Bauer DJ, Preacher KJ, Gil KM. Conceptualizing and testing random indirect effects and moderated mediation in multilevel models: new procedures and recommendations. Psychol Methods. 2006 Jun;11(2):142-63. doi: 10.1037/1082-989X.11.2.142.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Hilliard ME, Minard CG, Marrero DG, de Wit M, Thompson D, DuBose SN, Verdejo A, Monzavi R, Wadwa RP, Jaser SS, Anderson BJ. Assessing Health-Related Quality of Life in Children and Adolescents with Diabetes: Development and Psychometrics of the Type 1 Diabetes and Life (T1DAL) Measures. J Pediatr Psychol. 2020 Apr 1;45(3):328-339. doi: 10.1093/jpepsy/jsz083.