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临床试验/NCT07569991
NCT07569991尚未招募不适用

Digitally Enhanced Cognitive-Behavioral Therapy for Adolescents With Depression and Obesity

Colorado State University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Intervention Acceptability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Cognitive-behavioral therapy (CBT)

Active Comparator

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

干预措施: Cognitive-behavioral therapy (CBT) (Behavioral)

Cognitive-behavioral therapy-Plus (CBT+)

Experimental

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

干预措施: Digital app (Behavioral)

Cognitive-behavioral therapy-Plus (CBT+)

Experimental

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

干预措施: Cognitive-behavioral therapy (CBT) (Behavioral)

结局指标

主要结局

Intervention Acceptability

时间窗: Six-week follow-up

≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)

Intervention Feasibility

时间窗: Six-week follow-up

≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)

App Acceptability

时间窗: Six-week follow-up

Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)

次要结局

  • Enrollment Feasibility(End-of-enrollment)
  • Protocol Feasibility(End-of-3-month follow-ups)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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