ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes

Scripps Whittier Diabetes Institute

Status and phase

Enrolling

Phase 2

Conditions

Type 1 Diabetes

Treatments

Behavioral: ACT1VATE

Behavioral: DSME/S

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04933851

R01DK127491 (U.S. NIH Grant/Contract)

1R01DK127491

Details and patient eligibility

About

This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.

Full description

This randomized controlled trial will compare a telemedicine psychological intervention specifically designed to address diabetes distress ("ACT1VATE") versus traditional diabetes self-management education and support (DSME/S; usual care) in improving glycemic control among N=250 adults with type 1 diabetes (T1D), glycosylated hemoglobin (HbA1c) between 7.5% - 12.5% in the last 90 days, and significant diabetes distress. Capitalizing on existing and real-world processes, the electronic health record (EHR) will be used to identify eligible patients and examine primary outcomes. Participants randomized to the usual care group will be offered standard, 1:1 DSME/S delivered by a Certified Diabetes Care and Education Specialist via telemedicine format. Participants randomized to the ACT1VATE group will be offered 5 group-therapy telemedicine sessions delivered by a Behavioral Health Provider who is an integrated member of the diabetes care team. ACT1VATE is grounded in Acceptance and Commitment Therapy (ACT), which has been delivered effectively in clinics via brief format; implemented via phone and other modalities; and adapted for a wide range of chronic conditions. The primary clinical outcome, HbA1c, assessed as part of quarterly standard-of-care medical visits will be extracted from the EHR over 12 months. Changes in patient-reported behavioral (diabetes self-care) and psychosocial (emotional well-being, quality of life) outcomes will be evaluated via online surveys at baseline, month 6, and month 12. A thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient and provider perspectives. Cost-effectiveness will also be examined from the health system perspective. By maximizing integration with routine medical care for T1D in a real world, healthcare environment, results will be highly generalizable and hold great potential to inform the future of care for adults living with T1D.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Spanish or English-speaking
Type 1 diabetes
Glycosylated Hemoglobin (HbA1c) 7.5% - 12.5% in last 90 days
Screen positive for diabetes distress

Exclusion criteria

Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider
Plans to move out of the San Diego area in the next 12 months
Lack of technology capability required to complete online surveys and telemedicine visit

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

250 participants in 2 patient groups

ACT1VATE

Experimental group

Description:

Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.

Treatment:

Behavioral: ACT1VATE

DSME/S (usual care)

Active Comparator group

Description:

Participants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME/S).

Treatment:

Behavioral: DSME/S