Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)

Colorado State University (CSU)

Status: Begins enrollment in 3 months

Conditions: Cognitive-behavioral Therapy; Mobile Health Technology (mHealth); Obesity & Overweight; Depression in Adolescence; Health Behavior

Treatments: Behavioral: Digital app; Behavioral: Cognitive-behavioral therapy (CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07569991

25-0997

R34HL180788 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Adolescent depression is a major public health problem. Depression affects adolescents' emotional well-being now and in the future, and it also affects their physical health, especially the risk for heart disease and other cardiovascular and metabolic health problems. In adolescents with depression and obesity, evidence-based programs for depression, like cognitive-behavioral therapy (CBT), might improve physical health, in part by supporting healthy behaviors such as physical activity, nutritious eating, and getting enough sleep. Our preliminary studies provide support for this overarching hypothesis. If adolescents have access to a digital app to support practicing CBT skills in between program sessions, it might especially help them to learn skills that help to feel better and be healthier in their day-to-day lives. We are tailoring a digital app for this purpose and we will make changes to the app based on feedback from adolescents, their parents, and their doctors. Once the app is well-liked and helpful, and works well as a support for taking part in CBT, we will randomly assign 60 adolescents with depression and overweight/obesity to either "CBT+" - a CBT group program plus the app, or "CBT-only" - the CBT group program only. We will pilot test whether this research is feasible, likeable, and credible, learning information that will inform a larger study to test of CBT+ can support emotional well-being, health behavior, and cardiovascular and metabolic health in adolescents.

Full description

Adolescent depression is a major public health problem that has serious consequences for cardiometabolic disease, predicting heightened risk for glucose dysregulation, type 2 diabetes onset, and cardiovascular events. Evidence-based interventions such as cognitive-behavioral therapy (CBT) to decrease depression in adolescents with elevated body mass index (BMI ≥85th percentile for age and sex) are anticipated to improve cardiometabolic health, in part by ameliorating the negative impacts of depression on health behavior (e.g., physical activity, eating, and sleep). Our preliminary studies provide support for this overarching hypothesis. However, effect sizes for CBT were small-to-moderate, possibly due to less-than-optimal home practice in between sessions. Homework completion tracks with treatment effects in our team's and others' studies, likely because homework facilitates skills acquisition in daily life. Our overarching study rationale is that enhancement of CBT-group with a digital app is likely to strengthen homework completion and translation of CBT skills to healthier coping and behavior, leading to stronger improvements in cardiometabolic health than CBT-group alone. We will leverage mobile health (mHealth) to adapt a CBT-digital app for the distinct needs and preferences of adolescents with depression and elevated BMI. After we optimize the app's integration with CBT-group virtual sessions through focus groups and iterative pilot testing with adolescents, we will conduct a two-arm, single-site pilot and feasibility randomized controlled trial to compare a digitally-enhanced CBT-group (CBT+) with a virtual CBT-group only in 60 adolescents with depression and overweight/obesity to assess feasibility, acceptability, proof-of-concept, and implementation outcomes.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 12-17 years
• Body mass index (BMI) ≥85th percentile for age and sex
• Elevated depression symptoms, Center for Epidemiologic Studies-Depression Scale (CES-D) ≥21

Exclusion criteria

• Type 2 diabetes; Fasting glucose ≥126 mg/dL or HbA1c ≥6.5
• Major developmental (e.g., intellectual developmental disability) or medical or genetic condition (e.g. cancer, Bardet-Biedhl)
• Pregnancy/breastfeeding (females)
• Bariatric surgery, weight loss medication, or weight loss >3% in the past 3 months
• Active suicidality or self-harm

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Cognitive-behavioral therapy (CBT)

Active Comparator group

Description:

Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood

Treatment:

Behavioral: Cognitive-behavioral therapy (CBT)

Cognitive-behavioral therapy-Plus (CBT+)

Experimental group

Description:

Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood PLUS access to a digital app to use throughout the CBT group program

Treatment:

Behavioral: Digital app

Behavioral: Cognitive-behavioral therapy (CBT)