Group Therapy for Depression in Teens with Type 2 Diabetes

Overseen By Lauren Gulley, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Psychotropic meds

Disqualifiers: Psychotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two group programs to help teens with Type 2 Diabetes manage depression and stress related to diabetes. One program focuses on interpersonal psychotherapy (IPT) to build social skills, while the other provides health education about diabetes. Both programs meet for one hour a week over six weeks. Teens who have had Type 2 Diabetes for at least three months and experience high levels of depression may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for teens to explore new ways to manage their mental health and diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have been on psychotropic medications for less than 8 weeks, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that interpersonal psychotherapy (IPT) is generally well-tolerated by teenagers with depression. One study found that both IPT and similar treatments improved mood without causing significant side effects, suggesting the therapy is safe for young people.

For the health education program tailored for Type 2 Diabetes, research also supports its safety. Early evidence from similar cognitive-behavioral programs showed a reduction in depressive symptoms over six weeks, with no major negative effects reported. This indicates that both programs in the trial are safe options for teens with Type 2 Diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a unique approach to tackling depression in teens with Type 2 diabetes. Unlike standard treatments that often involve medication, these methods focus on mental health support through group therapy. Interpersonal Psychotherapy adapted for Type 2 Diabetes (IPT-T2D) addresses the social and relational aspects of living with both diabetes and depression, providing tailored support in a group setting. Meanwhile, the Health Education-T2D program empowers teens by enhancing their understanding of diabetes management, potentially improving both their physical and mental health. This dual focus on psychological and educational support offers a holistic alternative to traditional depression treatments.

What evidence suggests that this trial's treatments could be effective for depression in teens with Type 2 Diabetes?

Research has shown that Interpersonal Psychotherapy (IPT), one of the treatments in this trial, effectively treats depression. A review of several studies found that IPT helped teenagers with depression both immediately after treatment and six months later. Another study found that IPT can also help prevent new episodes of depression and relapses.

In contrast, the Health Education program, another treatment arm in this trial, has less evidence supporting its effectiveness in reducing depression. Studies have shown that people with diabetes often continue to experience depression symptoms even after a year. While learning about diabetes is important, it might not directly alleviate depression symptoms. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adolescents with Type 2 Diabetes who are also experiencing depression. The study aims to include those who can participate in group programs and are looking for ways to manage both their mental health and diabetes.

Inclusion Criteria

HbA1c ≥7.0%

I have been diagnosed with Type 2 Diabetes for at least 3 months.

I am between 12 and 17 years old.

Exclusion Criteria

I am currently seeing a licensed therapist for psychotherapy.

I have not started any new psychotropic medications in the last 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either group-based interpersonal psychotherapy or health education adapted for Type 2 Diabetes for 6 weeks

6 weeks

6 visits (in-person, weekly)

Follow-up

Participants are monitored for changes in depression levels, diabetes distress, and glycemic control

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Group Program

Trial Overview

The trial is testing a group-based interpersonal psychotherapy (IPT) program against a diabetes education program, focusing on the impact these have on depression levels, emotional distress related to diabetes, and blood sugar control.

How Is the Trial Designed?

Group I: Interpersonal Psychotherapy adapted for Type 2 Diabetes Experimental Treatment 1 Intervention

Participants in the IPT-T2D will receive 1 hour weekly IPT from a licensed psychologist in a group setting for 6 weeks.

Group II: Health Education adapted for Type 2 Diabetes Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

A 6-week cognitive behavioral therapy (CBT) program helped reduce depressive symptoms in adolescent females at risk for type 2 diabetes, with significant improvements noted in those with moderate baseline depression.

While overall insulin sensitivity remained stable in both the CBT and health education groups, girls with moderate depressive symptoms in the CBT group showed a significant reduction in 2-hour insulin levels, suggesting potential metabolic benefits from CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of insulin resistance in adolescents at risk for type 2 diabetes with depressive symptoms: 1-year follow-up of a randomized trial. Shomaker, LB., Kelly, NR., Radin, RM., et al.[2020]

In a study of 119 adolescent girls at risk for type 2 diabetes, those who received cognitive-behavioral therapy (CBT) showed significant decreases in depression, which in turn was linked to lower fasting insulin levels after one year.

The results suggest that reducing depression may help prevent type 2 diabetes in at-risk adolescents, particularly for those with higher initial levels of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect Effects of a Cognitive-Behavioral Intervention on Adolescent Weight and Insulin Resistance Through Decreasing Depression in a Randomized Controlled Trial. Gulley, LD., Shomaker, LB., Kelly, NR., et al.[2021]

Citations

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Diabetes and Depression - Endotext - NCBI Bookshelf

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This article highlights recent findings related to psychosocial and behavioral health concerns among people living with diabetes.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03263351

Depression & Insulin Sensitivity in Adolescents

In preliminary data, the investigators found initial evidence that a 6-week cognitive-behavioral group decreased depressive symptoms and prevented worsening of ...

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diabetesjournals.org

diabetesjournals.org/spectrum/article/38/1/23/157816/The-Interconnected-Complexity-of-Diabetes-and

The Interconnected Complexity of Diabetes and Depression

Findings revealed that participants with impaired FPG and undiagnosed type 2 diabetes did not have an increased risk of depressive symptoms, ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0168822725000282

The role of depression and diabetes distress in glycemic ...

Emerging evidence suggests that depression and diabetes distress substantially affect diabetes outcomes, with up to 36 % of individuals with type 2 diabetes ( ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10037371/

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A study by the Pediatric Diabetes Consortium found that youth with T2DM had double the number of depressive symptoms compared to those with T1DM ...

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cdc.gov/diabetes/data-research/research/young-people-mental-health.html

Mental Health for Kids and Teens With Diabetes

Young people with diabetes were nearly twice as likely to have a mental, emotional, or behavioral disorder or developmental or language disorder compared to ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10107478/

Psychological care of children, adolescents and young adults ...

Youth with T2D and DEB had a significantly higher BMI, lower insulin sensitivity, more depressive symptoms, and poorer QoL than those without DEB, with no ...

9.

diabetesjournals.org

diabetesjournals.org/care/article/47/Supplement_1/S258/153946/14-Children-and-Adolescents-Standards-of-Care-in

14. Children and Adolescents: Standards of Care in Diabetes ...

Early detection of depression, anxiety, disordered eating, and learning disabilities can facilitate effective treatment options and help ...