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}

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

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

National Center for Advancing Translational Sciences (NCATS) Collaborator

Children's Hospital Colorado Collaborator

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

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] Depression is associated with poor insulin sensitivity. We evaluated the long-term effects of a cognitive behavioral therapy (CBT) program for prevention of depression on insulin sensitivity in adolescents at risk for type 2 diabetes (T2D) with depressive symptoms.

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] Depression in adolescence is linked to risk for type 2 diabetes (T2D). In this secondary data analysis of a randomized controlled trial comparing cognitive-behavioral therapy (CBT) to a control program to ameliorate insulin resistance via reducing depression symptoms, we examine which CBT change mechanisms (e.g., behavioral activation, cognitive restructuring) contributed to decreased depression and subsequent improvements in body mass index (BMI), percent body fat, and insulin resistance.

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

Cognitive-behavioral therapy for depression in adolescents with inflammatory bowel disease: a pilot study. [2018] To evaluate the safety and feasibility of cognitive-behavioral therapy (CBT) for depression in physically ill adolescents.

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

Cognitive-behavioral therapy for adolescent depression and suicidality. [2022] Cognitive-behavioral therapy (CBT) is a well-established treatment of depression in children and adolescents but treatment trials for adolescents with suicidality are few in number, and their efficacy to date is limited. This article reviews the rationale underlying the use of CBT for the treatment of depression and suicidality in adolescents, the literature supporting the efficacy of CBT for depressed adolescents, and whether CBT for depression reduces suicidal thoughts and behavior. A description of some of the core cognitive, affective, and behavioral techniques used in CBT treatments of suicidal ideation and behavior in depressed adolescents is included.

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] This group case study describes the course of a 14-session Cognitive Behavioral Therapy (CBT) for Latino adolescents with Type 1 Diabetes Mellitus (T1DM) and depressive symptoms. The intervention, known as CBT-DM, is an adaptation of an efficacious group intervention for adolescent depression. The treatment rationale and cultural adaption model are described as well as procedures used to achieve sensitivity to the characteristics of the T1DM culture as experienced by Latino youth from Puerto Rico. Session-by-session protocol is reviewed and treatment gains on the group as a whole and on its individual members are presented, providing quantitative and qualitative data. Treatment feasibility, clients' acceptance and satisfaction with treatment, and follow-up data up to 6 months post-treatment are also examined, considering cognitive, behavioral, emotional, relational, medical, and functional outcomes. Complicating factors, barriers to care, and treatment implications are discussed in the context of treating clients with comorbid chronic physical illness and emotional problems also embedded in a Latino culture. Translation of evidence-based treatments for depression into primary care settings and adapting protocols to youth populations with other medical illnesses is proposed. Recommendations for clinicians are provided, emphasizing the establishment of collaborative relationships with clients, assessing their stage in the process of accepting their chronic illness, as well as understanding their overall context to avoid unnecessary attributions of pathology to their thoughts, behaviors, and feelings.

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] Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed.

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

Effectiveness of group CBT in treating adolescents with depression symptoms: a critical review. [2019] Depression is among the most common psychological disorders of adolescents. Its management is based on pharmacological treatment, psychological therapy, or a combination thereof. Cognitive behavioral therapy (CBT) is the most extensively tested intervention for adolescent depression. A PubMed search was conducted for randomized controlled trials (RCT) of the efficacy of CBT in treating adolescents with depressive symptoms published in 2005-2015. Keywords were "cognitive behavioral therapy", "group therapy", "depression" and "adolescent". Of the 23 papers that were retrieved, only six met all inclusion criteria. Three of them reported a significant reduction in depressive symptom severity after either individual or group (G)-CBT compared with the control group, even with a small number of CBT sessions (six rather than 10-12), with a medium or medium-to-large effect size. One study reported improved self-awareness and a significantly greater increase in perceived friend social support compared with bibliotherapy and check with brochure. Two studies reported clinical symptom reduction without significant differences compared with the control group (activity contrast). This review highlighted primarily that very few RCT have applied CBT in adolescents; moreover, it confirmed the effectiveness of G-CBT, especially as psychotherapy, although it was not always superior to other interventions (e.g. other activities in prevention programs). Comparison showed that G-CBT and group interpersonal psychotherapy were both effective in reducing depressive symptoms. Successful G-CBT outcomes were related to the presence of peers, who were an important source of feedback and support to observe, learn, and practice new skills to manage depressive symptoms and improve social-relational skills.

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

Psychosocial treatment of depression and suicidality in adolescents. [2022] Depression is a common disorder among adolescents and is associated with a high risk of suicide. Suicide is the third leading cause of death among adolescents in the United States. Currently, there are only two evidence-based psychotherapies for adolescence depression: cognitive-behavioral therapy and interpersonal psychotherapy. Furthermore, psychosocial interventions that specifically target suicidal behavior in adolescents are even fewer in number than treatments for depression. This article will review the psychosocial interventions for depression and suicidality in adolescents and will describe a recently developed treatment that is under study for depressed suicidal adolescents.

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

Psychosocial treatments for adolescent depression. [2019] Major Depressive Disorders affect between 2% and 5% of adolescents at any one point in time. Depression in adolescence is associated with serious psychosocial deficits and has negative effects on functioning during young adulthood. Starting with the pioneering work of Lenore Butler and her colleagues, many psychosocial interventions have been developed and studied, with generally positive results. On the basis of a meta-analysis of the existing cognitive-behavioral therapy (CBT) studies we estimate an overall effect size of 1.27 and that 63% of patients show clinically significant improvement at the end of treatment. It seems reasonable to conclude that CBT has been demonstrated to be an effective treatment for depressed adolescents. In this article we describe these interventions, most of which are meant to address the problems shown by depressed adolescents. The purpose of our article is to bring this literature to the attention of clinicians in a manner which quickly and clearly summarizes the key features of the interventions to make it easy for clinicians to take advantage of this wealth of information and to avail themselves of the existing resources. We conclude by suggesting future directions and several additional areas of application for adolescent depression treatments.