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

50 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Group Program for depression in teens with Type 2 Diabetes?

While there is no direct data on the Group Program, research shows that depression is common in teens with diabetes, and addressing mental health is important. Cognitive behavioral therapy (CBT), a type of group therapy, has been shown to help with depression and improve insulin sensitivity in teens at risk for Type 2 Diabetes. ^{1 2 3 4 5}

Is group therapy safe for teens with type 2 diabetes and depression?

Group therapy, often using cognitive-behavioral therapy (CBT), has been studied in teens with depression and type 2 diabetes, and no specific safety concerns have been reported in these studies. It is generally considered safe for use in humans. ^{1 2 4 5 6}

How is the Group Program treatment for depression in teens with type 2 diabetes different from other treatments?

The Group Program treatment is unique because it combines group therapy with a focus on managing both depression and type 2 diabetes, which is not commonly addressed together in standard treatments. This approach may help improve both mental health and insulin sensitivity, offering a more holistic treatment for teens facing these dual challenges. ^{1 2 5 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Depression in adolescents with diabetes. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Discrepancies in Assessing Symptoms of Depression in Adolescents With Diabetes Using the Patient Health Questionnaire and Semi-Structured Interviews. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A retrospective multisite examination of depression screening practices, scores, and correlates in pediatric diabetes care. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Depressive Symptoms in Youth With Type 1 or Type 2 Diabetes: Results of the Pediatric Diabetes Consortium Screening Assessment of Depression in Diabetes Study. [2022]

5. United States 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. [2020]

6. United States 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Mental health comorbidity and youth onset type 2 diabetes: A systematic review of the literature. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Glycemic control, depression, diabetes distress among adolescents with type 2 diabetes: effects of sex, race, insurance, and obesity. [2022]