Type 2 DiabetesNCT06285487
Depression in Youth Onset Type 2 Diabetes
A study testing Group Program in people with Type 2 Diabetes and Depression, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 2 Diabetes, Depression
- What is being tested?
- Group Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 2 Diabetes diagnosis ≥ 3 months
- Age 12-17yr
- Elevated depression symptoms
- HbA1c ≥7.0%
Who cannot join
- Currently receiving psychotherapy from a licensed counselor
- Psychotropic meds <8 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes.
- Conditions
- Type 2 Diabetes, Depression
- Being tested
- Group Program
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ProgramBehavioural
Participants in both arms will receive 6 weeks of T2D-IPT or 6 weeks of T2DEd.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy adapted for Type 2 Diabetes | Experimental | Participants in the IPT-T2D will receive 1 hour weekly IPT from a licensed psychologist in a group setting for 6 weeks. Receives: Behavioral: Group Program |
| Health Education adapted for Type 2 Diabetes | Experimental | Participants in the Health Education-T2D will receive 1 hour weekly Health Education lessons from a licensed psychologist in a group setting for 6 weeks. Receives: Behavioral: Group Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of IPT-T2D
Assessed by likeability, credibility, and descriptions by adolescents, parents, and facilitators
Measured: 3 Months
Depression Changes
Assessed by CESD
Measured: 3 Months
Changes in Glycemic Control
Assessed by changes in HbA1c
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285487
- Sponsor's protocol ID
- 23-1600
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression in Youth Onset Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06285487
- Acronym / sponsor ID
- 23-1600
- Conditions
- Type 2 Diabetes, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
The main purpose of this study is to compare a group-based interpersonal psychotherapy (IPT) program and a Type 2 Diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy adapted for Type 2 Diabetes | Experimental | Behavioral: Group ProgramParticipants in the IPT-T2D will receive 1 hour weekly IPT from a licensed psychologist in a group setting for 6 weeks. |
| Health Education adapted for Type 2 Diabetes | Experimental | Behavioral: Group ProgramParticipants in the Health Education-T2D will receive 1 hour weekly Health Education lessons from a licensed psychologist in a group setting for 6 weeks. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Type 2 Diabetes diagnosis ≥ 3 months
- Age 12-17yr
- Elevated depression symptoms
- HbA1c ≥7.0%
Key exclusion criteria (2 listed)
- Currently receiving psychotherapy from a licensed counselor
- Psychotropic meds <8 weeks
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 |
|---|---|---|
| Group ProgramParticipants in both arms will receive 6 weeks of T2D-IPT or 6 weeks of T2DEd. | Behavioural | Health Education adapted for Type 2 Diabetes, Interpersonal Psychotherapy adapted for Type 2 Diabetes |
Primary outcome
Acceptability of IPT-T2D
Time frame: 3 Months
Assessed by likeability, credibility, and descriptions by adolescents, parents, and facilitators
Depression Changes
Time frame: 3 Months
Assessed by CESD
Changes in Glycemic Control
Time frame: 3 Months
Assessed by changes in HbA1c
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Program in people with Type 2 Diabetes and Depression, run by University of Colorado, Denver 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 2 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren Gulley, PhD (720-777-8379, lauren.gulley@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of IPT-T2D (time frame: 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2024.