Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

Not Applicable

Completed

Conditions: Diabetes Distress
Type 1 Diabetes

Registration Number: NCT04016558

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 296

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diabetes Distress at 12 Months	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).
Hemoglobin A1c (HbA1c) at 12 Months	12 months	Hemoglobin A1c (HbA1c) assay laboratory result

Secondary Outcome Measures

Name	Time	Method
Hypoglycemic Episodes at 12 Months	12 months	Self-reported number of severe of hypoglycemic episodes in the past 6 months, or since the last assessment. A numeric count is reported, zero indicates no hypoglycemic episodes, and a higher number indicates more hypoglycemic episodes.
Depression Symptoms at 12 Months	12 months	Symptoms of depression will be measured using the self-completion Patient Health Questionnaire (PHQ-8). The score ranges from zero to 24 with a higher score indicating more symptoms of depression.
Missed Insulin Boluses at 12 Months	12 months	Self-reported number of missed or skipped insulin boluses in the past week
Nonreactivity to Inner Experience at 12 Months	12 months	Nonreactivity to inner experience will be assessed by the nonreactivity sub-scale of the Five Facet Mindfulness Questionnaire. Items are scored from 1-5 with items summed to calculate a total scale score. The total score ranges from 7-35. Higher scores indicate greater nonreactivity to inner emotional experiences.
Non-judging of Experience at 12 Months	12 months	Non-judging of experience will be assessed by the nonjudgmental subscale of the Five Facet Mindfulness Questionnaire. Individual items are scored on a 1-5 scale and then summed to calculate a scale score with higher scores indicating greater non-judging of emotional experience. The total score ranges from 8-40.
Personal Control Over Illness at 12 Months	12 months	The personal control subscale from the Revised Illness Perception Questionnaire will assess participants' perceived control over their illness. The items are scored on a 1-5 scale and summed across items for a total score with higher scores indicating greater personal control. The total score ranges from 6-30.
Self-compassion - Diabetes (SCS-D) at 12 Months	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.

Trial Locations

Locations (1): University of California, San Francisco
🇺🇸
San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States