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Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control (EMBARK)

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ClinicalTrials.gov Identifier: NCT04016558
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This study is comparing three programs to reduce Diabetes Distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. About a third of participants will take part in the TunedIn program, about a third will take part in the FixIt program, and about a third in the StreamLine program.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Diabetes Distress Behavioral: StreamLine Behavioral: TunedIn Behavioral: FixIt Not Applicable

Detailed Description:

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 range. When high, DD can have a major, negative impact on disease management and glycemic control. 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 resources.

The proposed study is a three-arm, 12-month randomized comparison trial 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 three programs (arms) will follow a separate, standardized protocol. All participants will receive three months of intervention with nine months of follow-up.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Affective and Unified Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: StreamLine
Diabetes education, behavioral management
Behavioral: StreamLine

StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.

Participants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts.


Experimental: TunedIn
Diabetes distress reduction, emotion regulation techniques.
Behavioral: TunedIn

TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two 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 blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).

Between the two workshops (two weeks), participants will complete a "feeling log" to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time.


Experimental: FixIt
Unified program combining diabetes education, behavioral management, diabetes distress reduction, and emotion regulation techniques.
Behavioral: FixIt

FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.

Between the two workshops, participants will record their blood glucose data and keep a parallel "feeling log" to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time.





Primary Outcome Measures :
  1. Diabetes Distress [ Time Frame: Change from baseline to 12 months ]
    Self-reported diabetes distress across several domains will be assessed using the Type 1 Diabetes Distress Scale (T1-DDS) a validated measure averaged across items (range 1.0-6.0 with higher scores indicating a higher level of diabetes-related distress).

  2. Hemoglobin A1c (HbA1c) [ Time Frame: Change from baseline to 12 months ]
    Assay


Secondary Outcome Measures :
  1. Broad quality of life [ Time Frame: Change from baseline to 12 months ]
    Broad quality if life will be measured using the World Health Organization (Five) Well-Being Index (WHO-5)

  2. Hypoglycemic episodes [ Time Frame: Change from baseline to 12 months ]
    Self-reported number and severity of hypoglycemic episodes in the past 6 months, or since the last assessment

  3. Depression [ Time Frame: Change from baseline to 12 months ]
    Symptoms of depression will be measured using the self-completion Patient Health Questionnaire (PHQ-8)

  4. Insulin adherence [ Time Frame: Change from baseline to 12 months ]
    Self-reported number of missed or skipped insulin boluses in the past week

  5. Nonreactivity to inner experience [ Time Frame: Change from baseline to 12 months ]
    Nonreactivity to inner experience will be assessed by the nonreactivity subscale of the Five Facet Mindfulness Questionnaire

  6. Non-judging of experience [ Time Frame: Change from baseline to 12 months ]
    Non-judging of experience will be assessed by the nonjudgmental subscale of the Five Facet Mindfulness Questionnaire

  7. Personal Control Over Illness [ Time Frame: Change from baseline to 12 months ]
    The personal control subscale from the Revised Illness Perception Questionnaire will assess participants' perceived control over their illness.

  8. Interpersonal emotion regulation [ Time Frame: Change from baseline to 12 months ]
    Interpersonal Emotion Regulation measure (IERQ) will be used to assess openness to using social resources and supports to manage diabetes distress

  9. Self-compassion - Diabetes (SCS-D) [ Time Frame: Change from baseline to 12 months ]
    Diabetes-specific self-compassion will be measured using the validate Self-Compassion Scale - Diabetes (SCS-D) in which the average of items is calculated. Items are scored on a scale from 1 to 5 with higher scores indicative of greater self compassion.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with type 1 diabetes (confirmed by clinical history and/or anti-glutamic acid decarboxylase] antibody testing) on intensive insulin treatment;
  • Diagnosis of type 1 diabetes for at least 12 months that occurred at or below age 40;
  • Have a recent HbA1c of 7.5% or higher;
  • 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.

Exclusion Criteria:

  • No documented psychosis, blindness, dementia, active dialysis, substance abuse, amputations, or severe functional deficits, or recent major surgery or hospitalization in the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016558


Contacts
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Contact: Danielle Hessler, Ph.D. (415) 476-6196 danielle.hessler@ucsf.edu
Contact: Vicky Bowyer, MSc. (415) 476-5679 vicky.bowyer@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Danielle Hessler, Ph.D. University of California, San Francisco

Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04016558     History of Changes
Other Study ID Numbers: 133107A
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases