Type 1 DiabetesPhase 2NCT04933851
ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
A Phase 2 study testing ACT1VATE and DSME/S in people with Type 1 Diabetes, run by Scripps Whittier Diabetes Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- ACT1VATE and DSME/S
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spanish or English-speaking
- Type 1 diabetes
- Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days
- Screen positive for diabetes distress
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Scripps Whittier Diabetes Institute
San Diego, California, 92121
Addie Fortmann, PhD, 858-922-2276, fortmann.adelaide@scrippshealth.org
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- ACT1VATE, DSME/S
- Keywords
- Type 1 Diabetes, Emotional Distress
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT1VATEBehavioural
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/SBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT1VATE | Experimental | Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress. Receives: 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). Receives: Behavioral: DSME/S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (8)
Summary of Diabetes Self-Care Activities Survey
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.
Measured: Baseline, 6 months, 12 months
Generalized Anxiety Disorder Assessment
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.
Measured: Baseline, 6 months, 12 months
Patient Health Questionnaire-8
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.
Measured: Baseline, 6 months, 12 months
Perceived Stress Scale
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.
Measured: Baseline, 6 months, 12 months
The WHO Well-Being Index
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.
Measured: Baseline, 6 months, 12 months
Hypoglycemic Attitudes and Behaviors Scale
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.
Measured: Baseline, 6 months, 12 months
Revised Diabetes Knowledge Test
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.
Measured: Baseline, 6 months, 12 months
Diabetes Support and Isolation Questionnaire
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.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start25 Oct 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
- Investigators
- Addie Fortmann, PhD, Principal investigator, Scripps Whittier Diabetes InstituteAthena Philis-Tsimikas, MD, Principal investigator, Scripps Whittier Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933851
- Sponsor's protocol ID
- 1R01DK127491
- Other IDs
- R01DK127491
- Status last verified
- May 2026
- First submitted
- 4 Jun 2021
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39265782
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04933851
- Acronym / sponsor ID
- 1R01DK127491
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Emotional Distress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT1VATE | Experimental | Behavioral: ACT1VATEParticipants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress. |
| DSME/S (usual care) | Active comparator | Behavioral: DSME/SParticipants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME/S). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spanish or English-speaking
- Type 1 diabetes
- Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days
- Screen positive for diabetes distress
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT1VATEACT1VATE, informed by Acceptance and Commitment Therapy (ACT), will consist of five, 90-minute group-based telemedicine therapy sessions delivered by a Behavioral Health Provider. | Behavioural | ACT1VATE |
| DSME/SDiabetes self-management education and support (DSME/S) will be delivered by a Certified Diabetes Care and Education Specialist via one-on-one telemedicine format. | Behavioural | DSME/S (usual care) |
Primary outcome
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.
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.
8 secondary outcomes
Summary of Diabetes Self-Care Activities Survey
Time frame: Baseline, 6 months, 12 months
Generalized Anxiety Disorder Assessment
Time frame: Baseline, 6 months, 12 months
Patient Health Questionnaire-8
Time frame: Baseline, 6 months, 12 months
Perceived Stress Scale
Time frame: Baseline, 6 months, 12 months
The WHO Well-Being Index
Time frame: Baseline, 6 months, 12 months
Hypoglycemic Attitudes and Behaviors Scale
Time frame: Baseline, 6 months, 12 months
Revised Diabetes Knowledge Test
Time frame: Baseline, 6 months, 12 months
Diabetes Support and Isolation Questionnaire
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 39265782Soriano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Addie Fortmann, PhD principal investigator
Scripps Whittier Diabetes Institute
Athena Philis-Tsimikas, MD principal investigator
Scripps Whittier Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACT1VATE and DSME/S in people with Type 1 Diabetes, run by Scripps Whittier Diabetes Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Sandoval (970-497-6701, sandoval.haley@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 3 months, 6 months, 9 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04933851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.