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

NCT04933851 | Recruiting Phase 2 DMC

• 2 other identifiers: 1R01DK127491R01DK127491
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

Type 1 Diabetes; Emotional Distress

Outcome Measures

Primary Outcomes (2)

• Glycosylated Hemoglobin (HbA1c)

  HbA1c (%) reflects average glucose over the past 2-3 months, with higher values indicating greater risk for developing diabetes-related complications. HbA1c for up to 5 data points (0, 3, 6, 9, 12 months) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine HbA1c changes. Analyses will include the between-subjects factor of group and the within-subjects factor of time. Month 0 will be the referent time-point with post-intervention and follow-up time-points as comparison time-points in dummy-coded predictors. The group by time interaction is of primary interest. If an interaction is found significant, follow-up analyses will determine the nature of differential change between treatment conditions.

  Baseline, 3 months, 6 months, 9 months, 12 months

• Diabetes Distress Scale

  The Type 1 Diabetes Distress Scale (T1-DDS; 28 items averaged to obtain a total score ranging 1-6, with higher scores indicating greater diabetes-related emotional stress) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine change in diabetes distress over time. Analyses will include the between-subjects factor of group and the within-subjects factor of time. Month 0 will be the referent time-point with post-intervention and follow-up time-points as comparison time-points in dummy-coded predictors. The group by time interaction is of primary interest. If an interaction is found significant, follow-up analyses will determine the nature of differential change between treatment conditions.

  Baseline, 6 months, 12 months

Secondary Outcomes (8)

• Summary of Diabetes Self-Care Activities Survey

  Baseline, 6 months, 12 months

• Generalized Anxiety Disorder Assessment

  Baseline, 6 months, 12 months

• Patient Health Questionnaire-8

  Baseline, 6 months, 12 months

• Perceived Stress Scale

  Baseline, 6 months, 12 months

• The WHO Well-Being Index

  Baseline, 6 months, 12 months

Other Outcomes (4)

• Cost-effectiveness

  12 months

• Diabetes-Specific Self Compassion Scale

  Baseline, 6 months, 12 months

• Acceptance and Action Diabetes Questionnaire

  Baseline, 6 months, 12 months

Study Arms (2)

ACT1VATE

EXPERIMENTAL

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

Behavioral: ACT1VATE

DSME/S (usual care)

ACTIVE COMPARATOR

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

Behavioral: DSME/S

Interventions

ACT1VATE BEHAVIORAL

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.

ACT1VATE

DSME/S BEHAVIORAL

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.

DSME/S (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Whittier Diabetes Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Scripps Whittier Diabetes Institute

San Diego, California, 92121, United States

RECRUITING

Related Publications (1)

• Soriano EC, Fortmann AL, Guzman SJ, Sandoval H, Spierling Bagsic SR, Bastian A, Antrim M, Chichmarenko M, Philis-Tsimikas A. Addressing emotional distress to improve outcomes in adults with type 1 diabetes: Protocol for ACT1VATE randomized controlled trial. Contemp Clin Trials. 2024 Nov;146:107687. doi: 10.1016/j.cct.2024.107687. Epub 2024 Sep 13.

  PMID: 39265782 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Addie Fortmann, PhD

  Scripps Whittier Diabetes Institute

  PRINCIPAL INVESTIGATOR

• Athena Philis-Tsimikas, MD

  Scripps Whittier Diabetes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Sandoval

CONTACT

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

Addie Fortmann, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Corporate Vice President

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 22, 2021
• Study Start: October 25, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)