Cognitive Behavioral Therapy for Depression and Insulin Sensitivity in Adolescents

Overseen By Lauren B Shomaker, PhD

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: Colorado State University

Must not be taking: Insulin sensitizers, Antidepressants, Stimulants

Disqualifiers: Pregnancy, Type 2 diabetes, Major psychiatric disorders, 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 explores how cognitive-behavioral therapy (a type of talk therapy) can improve insulin sensitivity and manage depression in adolescent girls. It targets girls at risk for type 2 diabetes who have moderate depressive symptoms. Participants will join either a cognitive-behavioral therapy group or a health education group to determine which approach is more effective. Suitable candidates for this trial have moderate depressive symptoms, a family history of diabetes, and a higher body weight. As an unphased trial, this study allows participants to contribute to important research that could enhance mental and physical health outcomes for at-risk adolescents.

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 prior data suggests that cognitive-behavioral therapy is safe for adolescents?

Research has shown that cognitive-behavioral therapy (CBT) is generally safe and well-tolerated. Studies indicate that CBT can help reduce depression symptoms in many people, including teenagers, by changing negative thoughts and behaviors. The reviewed studies did not report any significant negative effects.

In group settings, CBT effectively reduces depression symptoms and improves health measures like body mass index (BMI) and insulin sensitivity. This is particularly important for teens at risk for type 2 diabetes and depression. While the studies focus on safety and effectiveness, participants have not reported any major negative experiences with the therapy itself.

Overall, CBT is a well-established treatment with a strong safety record, making it a good option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cognitive-behavioral therapy (CBT) for depression in adolescents because it targets not only mood but also physical health. Unlike typical treatments like antidepressants, which primarily address chemical imbalances in the brain, CBT helps teens develop practical skills to manage stress and emotions. This particular CBT approach also explores its potential to improve insulin sensitivity, which could have added benefits for physical health. The dual focus on mental and physical well-being makes it a promising alternative to traditional treatments.

What evidence suggests that this trial's treatments could be effective for depression and insulin sensitivity in adolescents?

This trial will compare the effects of cognitive-behavioral therapy (CBT) with a health education program. Research has shown that CBT can reduce depression symptoms, potentially improving insulin management in teenagers. Past studies found that CBT lowered insulin levels by alleviating depression. Lower insulin levels are important for preventing type 2 diabetes (T2D). CBT effectively reduces depression, which is linked to better overall health. Additionally, a review of several studies found that CBT significantly reduced depression symptoms, highlighting its mental health benefits. Overall, CBT may offer a promising approach to addressing both depression and insulin issues in teenagers at risk for T2D. ^{1 6 7 8 9}

Who Is on the Research Team?

Lauren B Shomaker, PhD

Principal Investigator

Colorado State University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-behavioral therapy group
• Health education group

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

A 14-session Cognitive Behavioral Therapy (CBT) program specifically adapted for Latino adolescents with Type 1 Diabetes Mellitus (T1DM) showed positive treatment gains, addressing both depressive symptoms and the unique cultural context of the participants.

The study highlighted the importance of cultural sensitivity in treatment, demonstrating that clients accepted and were satisfied with the CBT-DM intervention, which also provided valuable follow-up data on various outcomes up to 6 months post-treatment.

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]

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]

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]

Cognitive-behavioral therapy (CBT) is recognized as an effective treatment for depression in children and adolescents, but there is limited evidence specifically addressing its efficacy for adolescents experiencing suicidality.

The article discusses various CBT techniques aimed at reducing suicidal thoughts and behaviors in depressed adolescents, highlighting the need for more targeted treatment trials in this vulnerable group.

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]

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]

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]

Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for major depressive disorders in adolescents, with a meta-analysis revealing an overall effect size of 1.27 and 63% of patients experiencing clinically significant improvement after treatment.

The article aims to summarize various psychosocial interventions for depressed adolescents, making it easier for clinicians to access and utilize these resources in their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

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Examining Cognitive-Behavioral Therapy Change ... These results tentatively suggest that CBT may be a promising intervention to address depression, and subsequently, obesity and worsening insulin resistance, ...

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Indirect Effects of a Cognitive-Behavioral Intervention on ... There was an indirect effect of CBT on decreased 1-year fasting insulin via decreases in depression during treatment, among adolescents with ...

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Examining cognitive-behavioral therapy change ... Cognitive-behavioral therapy (CBT) is an evidence-based behavioral intervention that has shown significant effects for decreasing depression in the general ...

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Cognitive Behavioral Therapy for Depression and Insulin ... Research shows that Cognitive Behavioral Therapy (CBT) can help reduce depression symptoms, which is linked to improved insulin sensitivity in adolescents at ...

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A generalization meta-analysis of randomized controlled ... CBT significantly reduced depressive symptoms (SMD = –1.30, 95 % CI –2.46 to –0.13, p < 0.05), demonstrating substantial psychological benefits.

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Next-Generation Cognitive-Behavioral Therapy for ... This systematic review aims to present the latest developments in next-generation CBT interventions of digital support tools, teletherapies, and personalized ...