Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes

Summary

Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that arise through living with and managing diabetes. High DD is characterized by feeling frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a negative impact on disease management and glycemic control; poor glycemic control can also have a negative effect on DD.

Few interventions have been assessed that directly target DD or mood in adults with Type 1 diabetes. In this study the investigators will compare two active, evidence-based behavioral interventions to reduce high DD and improve glycemic control and disease management:

1. A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in diabetes education and behavioral management.
2. A DD-reduction protocol ('OnTrack') that helps identify and address the personal stresses and strains of having diabetes.

Participants in both arms will attend a single, day-long workshop, four hour-long web group meetings and four personal phone calls with the group facilitator during the intervention period. Assessments will be carried out at baseline and at three and nine months.

Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at follow-up.

Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the difference between the two study arms and primary outcome.

Hypothesis 3: The differences between the two study arms and changes in the primary outcomes will be qualified by patient characteristics such as age, length of diagnosis, higher baseline distress or HbA1c.

Conditions

• Type 1 Diabetes Mellitus

Interventions

BEHAVIORAL

'KnowIt'

Participants in the 'KnowIt' group will participate in a single, day-long group workshop led by a trained facilitator. Content covered during the program will focus on recent advances in diabetes care and self-management. During the three months following the initial workshop, participants will receive four telephone calls with their group facilitator to address any questions and challenges. One week after each phone call participants will take part in a 60 minute web meetings with their facilitator and other group members to review program content and discuss any challenges. Finally, participants will receive two further phone calls from their facilitator during months four to nine.

BEHAVIORAL

'OnTrack'

Participants in the 'OnTrack' group will participate in a single, day-long group workshop led by a trained facilitator. Content covered during the program will utilize an emotion-based adaptation of Problem Solving Therapy to target and reduce diabetes distress. During the three months following the initial workshop, participants will receive four telephone calls with their group facilitator to address any questions and challenges. One week after each phone call participants will take part in a 60 minute web meetings with their facilitator and other group members to review program content and discuss any challenges. Finally, participants will receive two further phone calls from their facilitator during months four to nine.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Lawrence Fisher, Ph.D. · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• United States

Study Locations