Cognitive Behavioral Therapy for Depression and Insulin Sensitivity in Adolescents

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Colorado State University

Must not be taking: Insulin sensitizers, Antidepressants, Stimulants

Disqualifiers: Pregnancy, Type 2 diabetes, Major psychiatric disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies, the investigators found that a brief cognitive-behavioral therapy group decreased depressive symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a cognitive-behavioral therapy depression group vs. a health education control group for improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up; 2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test changes in cortisol factors as explanatory.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications that affect mood, weight, cortisol, or insulin sensitivity, such as insulin sensitizers, anti-depressants, and stimulants.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Depression and Insulin Sensitivity in Adolescents?

Research shows that Cognitive Behavioral Therapy (CBT) can help reduce depression symptoms, which is linked to improved insulin sensitivity in adolescents at risk for type 2 diabetes. Additionally, CBT has been effective in decreasing depression and improving related health outcomes like body mass index and insulin resistance. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for adolescents?

Cognitive Behavioral Therapy (CBT) is generally considered safe for adolescents and is a well-established treatment for depression in this age group. It has been extensively tested and is one of the two evidence-based psychotherapies for adolescent depression, with no significant safety concerns reported in the studies reviewed. ^{3 4 6 7 8}

How is cognitive-behavioral therapy (CBT) unique for treating depression and insulin sensitivity in adolescents?

Cognitive-behavioral therapy (CBT) is unique because it not only addresses depression in adolescents but also has the potential to improve insulin sensitivity, which is important for those at risk of type 2 diabetes. Unlike medications, CBT focuses on changing negative thought patterns and behaviors, making it a non-drug approach that can have long-term benefits for both mental and physical health. ^{1 3 4 8 9}

Research Team

Eligibility Criteria

Adolescent girls aged 12-17 with moderate depression and a high risk for type 2 diabetes are eligible. They must have a family history of diabetes, be English-speaking, and have a BMI in the top 15% for their age and sex. Girls who already have type 2 diabetes, are pregnant or breastfeeding, on certain medications affecting mood or insulin sensitivity, or suffering from major psychiatric disorders cannot participate.

Inclusion Criteria

I am female.

I am between 12 and 17 years old.

Your depression score is higher than 20 on the CES-D scale.

Exclusion Criteria

I have not had thoughts or actions of harming myself.

You have a serious mental health condition that could make it hard for you to follow the study rules and may need more treatment. This includes conditions like depression, bipolar disorder, PTSD, panic disorder, OCD, schizophrenia, conduct disorder, alcohol or drug abuse, and anorexia or bulimia.

Pregnancy or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week cognitive-behavioral therapy group or a health education control group, with weekly 1-hour sessions

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in insulin sensitivity, depressive symptoms, and other secondary outcomes over a 1-year period

1 year

Treatment Details

Interventions

• Cognitive-behavioral therapy group (Behavioral)
• Health education group (Behavioral)

Trial Overview The trial is testing if cognitive-behavioral therapy can improve insulin sensitivity better than just health education in adolescent girls at risk for type 2 diabetes with depressive symptoms. The study will follow participants over one year to see changes in eating habits, physical activity, sleep patterns, and stress hormones.

Participant Groups

Group I: Cognitive-behavioral therapy group Experimental Treatment 1 Intervention

Six-session cognitive-behavioral therapy group program designed as a prevention of depression intervention for adolescents at-risk for depression. The program is facilitated by a psychologist. Sessions are weekly for 1-hour.

Group II: Health education group Active Control 1 Intervention

Six-session health education group program designed as a health education curriculum for teenagers. The program is facilitated by a psychologist. Sessions are weekly for 1-hour.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Children's Hospital Colorado Aurora, CO

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Patients Recruited

38,200+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2103

Patients Recruited

2,760,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Patients Recruited

404,000+

Children's Hospital Colorado

Collaborator

Trials

121

Patients Recruited

5,135,000+

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

Collaborator

Trials

2513

Patients Recruited

4,366,000+

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 involving 119 adolescent girls with overweight/obesity and a family history of type 2 diabetes, cognitive-behavioral therapy (CBT) was found to effectively reduce depression symptoms, which in turn led to significant decreases in body mass index (BMI) and insulin resistance after one year.

The study highlighted that increased physical activity and the enjoyment of social activities during CBT contributed to these positive outcomes, suggesting that behavioral activation strategies can be beneficial in preventing type 2 diabetes in at-risk adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining cognitive-behavioral therapy change mechanisms for decreasing depression, weight, and insulin resistance in adolescent girls at risk for type 2 diabetes. Gulley, LD., Shomaker, LB., Kelly, NR., et al.[2023]

Cognitive-behavioral therapy (CBT) for depression in physically ill adolescents (ages 12-17) was found to be safe and feasible, with no adverse events reported during the 12-session treatment.

Participants showed significant reductions in depressive symptoms and improvements in psychological and social functioning, indicating that this adapted CBT approach is a promising intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for depression in adolescents with inflammatory bowel disease: a pilot study. Szigethy, E., Whitton, SW., Levy-Warren, A., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for adolescent depression and suicidality. Spirito, A., Esposito-Smythers, C., Wolff, J., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Group Therapy for Latino youth with Type 1 Diabetes and depression: A case study. Cumba-Avilés, E.[2023]

A randomized controlled trial involving 70 adolescents aged 15 to 19 showed that an internet-delivered cognitive behavioral therapy (ICBT) blended with weekly therapist chat sessions significantly reduced depression symptoms compared to a minimal attention control group, with a large effect size (d=0.86).

46% of ICBT participants experienced clinically significant improvement in their depression, compared to only 11% in the control group, highlighting the efficacy of this blended treatment approach for adolescents with major depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial. Topooco, N., Byléhn, S., Dahlström Nysäter, E., et al.[2020]

Cognitive Behavioral Therapy (CBT) is an effective treatment for adolescent depression, with three out of six reviewed studies showing significant reductions in depressive symptoms after just a few sessions, indicating its efficacy even with limited intervention time.

Group CBT (G-CBT) not only reduced depressive symptoms but also enhanced social support among peers, suggesting that the group setting plays a crucial role in the therapy's success by providing feedback and opportunities to practice new skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of group CBT in treating adolescents with depression symptoms: a critical review. Nardi, B., Massei, M., Arimatea, E., et al.[2019]

Depression is a prevalent issue among adolescents and poses a significant risk for suicide, which is the third leading cause of death in this age group in the U.S.

Currently, there are only two established psychotherapies for treating adolescent depression—cognitive-behavioral therapy and interpersonal psychotherapy—highlighting a critical need for more effective psychosocial interventions targeting both depression and suicidal behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial treatment of depression and suicidality in adolescents. Brunstein Klomek, A., Stanley, B.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial treatments for adolescent depression. Lewinsohn, PM., Clarke, GN.[2019]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Examining cognitive-behavioral therapy change mechanisms for decreasing depression, weight, and insulin resistance in adolescent girls at risk for type 2 diabetes. [2023]

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

Cognitive-behavioral therapy for depression in adolescents with inflammatory bowel disease: a pilot study. [2018]

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

Cognitive-behavioral therapy for adolescent depression and suicidality. [2022]

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

Cognitive-Behavioral Group Therapy for Latino youth with Type 1 Diabetes and depression: A case study. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of group CBT in treating adolescents with depression symptoms: a critical review. [2019]

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

Psychosocial treatment of depression and suicidality in adolescents. [2022]

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

Psychosocial treatments for adolescent depression. [2019]