Recruiting
Phase 2

Emotional Distress

Sponsor:

Scripps Whittier Diabetes Institute

Code:

NCT04933851

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACT1VATE

DSME/S

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes

Study ID

NCT04933851

Start date

Oct 25, 2021

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Spanish or English-speaking
  • Type 1 diabetes
  • Glycosylated Hemoglobin (HbA1c) 7.0% - 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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ACT1VATE

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

active comparator: DSME/S (usual care)

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

Interventions

ACT1VATE

ACT1VATE, informed by Acceptance and Commitment Therapy (ACT), will consist of five, 90-minute group-based telemedicine therapy sessions delivered by a Behavioral Health Provider.

DSME/S

Diabetes self-management education and support (DSME/S) will be delivered by a Certified Diabetes Care and Education Specialist via one-on-one telemedicine format.

Primary outcome measure

  • Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
  • Diabetes Distress Scale [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Haley Sandoval

970-497-6701sandoval.haley@scrippshealth.org

Addie Fortmann, PhD

858-922-2276fortmann.adelaide@scrippshealth.org

Locations

Scripps Whittier Diabetes Institute

Recruiting

San Diego, California, United States, 92121

Contacts

Addie Fortmann, PhD

858-922-2276fortmann.adelaide@scrippshealth.org

More Information

Sponsor

Scripps Whittier Diabetes Institute

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Type 1 Diabetes
  • Emotional Distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Whittier Diabetes Institute on 2026-05-29.