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

May 27, 2026 updated by: Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 7.0% - 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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT1VATE
Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.
Behavioral: 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.
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).
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
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
Time Frame: Baseline, 6 months, 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Diabetes Self-Care Activities Survey
Time Frame: Baseline, 6 months, 12 months
Seven items regarding dietary and exercise behaviors from the Summary of Diabetes Self-Care Activities scale (SDSCA; items averaged to obtain a total score for each behavioral domain, ranging from 0-7, with higher scores indicating better outcomes/greater adherence to diabetes self-management behaviors) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine behavioral 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, 6 months, 12 months
Generalized Anxiety Disorder Assessment
Time Frame: Baseline, 6 months, 12 months
The Generalized Anxiety Disorder Assessment (GAD-7; 7 items are summed to obtain a total score, ranging from 0 to 21, with higher scores indicating worse outcomes/greater anxiety symptoms) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine anxiety symptom changes 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
Patient Health Questionnaire-8
Time Frame: Baseline, 6 months, 12 months
Patient Health Questionnaire (PHQ-8; 8 items averaged to obtain a total score, with higher scores indicating worse outcomes/greater depressive symptomatology) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine depressive symptom changes 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
Perceived Stress Scale
Time Frame: Baseline, 6 months, 12 months
Perceived Stress Scale (PSS-4; 4 items are summed to obtain a total score, ranging from 0-16, higher scores indicating worse outcomes/greater levels of perceived stress) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine stress level changes 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
The WHO Well-Being Index
Time Frame: Baseline, 6 months, 12 months
The WHO Well-Being Index (WHO-5; 5 items are summed and multiplied by 4 to obtain a total score ranging from 0-100, with higher scores indicating better outcomes/greater well-being/overall quality of life) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine quality of life 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, 6 months, 12 months
Hypoglycemic Attitudes and Behaviors Scale
Time Frame: Baseline, 6 months, 12 months
Hypoglycemic Attitudes and Behaviors Scale [HABS; a 14-item self-report scale that highlights three dimensions of hypoglycemia-related concerns (anxiety, avoidance, confidence), with higher scores indicating higher levels of patient worry and concerns related to hypoglycemia] will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in hypoglycemic attitudes and behaviors 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
Revised Diabetes Knowledge Test
Time Frame: Baseline, 6 months, 12 months
The Diabetes Knowledge Test (DKT; a 23-item multiple-choice questionnaire developed by the University of Michigan, with higher scores reflecting greater diabetes knowledge) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine knowledge changes 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
Diabetes Support and Isolation Questionnaire
Time Frame: Baseline, 6 months, 12 months
The Diabetes Support and Isolation Questionnaire (an 11-item, multiple choice questionnaire developed by University of California, San Francisco to assess available support resources for managing one's diabetes) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine changes in support resources 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 12 months
Long-term cost-effectiveness of ACT1VATE will use a simulation model. The UKPDS Outcomes Model Risk Engine (UKPDS-OM) developed the predictive equations for diabetes-related complications, mortality, and assigned utilities conditional on disease. Estimated clinical effects + costs of each arm will be inputs into the UKPDS-OM model. Estimated clinical effects (HbA1c change) come from Aim 1. Intervention costs will be estimated using standard accounting methods, process mapping + time-based activity costing. Base case assumes a health system perspective, 40-year time horizon, and 3% discount rate for both QALY and costs. Sensitivity analyses will investigate the influence of the estimated treatment effects and intervention costs, the influence of time horizon and discount rate, and second order uncertainty. UKPDS-OM provides equation parameters derived from bootstrap samples of the original UKPDS population. Estimates will be used to calculate an incremental cost-effectiveness plan.
12 months
Diabetes-Specific Self Compassion Scale
Time Frame: Baseline, 6 months, 12 months
Diabetes-Specific Self-Compassion Scale (D-SCS; range 0-5 with higher scores indicating higher levels of diabetes-specific self-compassion) will be analyzed to evaluate theoretical fidelity. Multilevel models using full information maximum likelihood estimation will be conducted to examine change in the construct 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
Acceptance and Action Diabetes Questionnaire
Time Frame: Baseline, 6 months, 12 months
The Acceptance and Action Diabetes Questionnaire (AADQ; a 6-item scale measuring cognitive avoidance related to diabetes with higher scores indicating higher levels of cognitive avoidance) will be analyzed to evaluate theoretical fidelity. Multilevel models using full information maximum likelihood estimation will be conducted to examine change in the construct 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
Body Mass Index (BMI)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Body Mass Index (BMI) - will be measured as Weight in kg/Height squared in meters. BMI 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 BMI 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Whittier Diabetes Institute

Collaborators

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

Investigators

  • Principal Investigator: Addie Fortmann, PhD, Scripps Whittier Diabetes Institute
  • Principal Investigator: Athena Philis-Tsimikas, MD, Scripps Whittier Diabetes Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DK127491 (U.S. NIH Grant/Contract)
  • R01DK127491 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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