Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)
2026年9月1日 更新者：Colorado State University
Digitally Enhanced Cognitive-Behavioral Therapy for Adolescents With Depression and Obesity
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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Lauren B Shomaker, PhD
- 電話番号：970-491-3217
- メール：lauren.shomaker@colostate.edu
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Anschutz Medical Campus
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コンタクト：
- Lauren Shomaker, PhD
- 電話番号：1-855-395-9031
- メール：lauren.shomaker@cuanschutz.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Cognitive-behavioral therapy (CBT)
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood
|
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
|
|
実験的：Cognitive-behavioral therapy-Plus (CBT+)
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
|
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intervention Acceptability
時間枠：Six-week follow-up
|
≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)
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Six-week follow-up
|
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Intervention Feasibility
時間枠：Six-week follow-up
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≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
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Six-week follow-up
|
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App Acceptability
時間枠：Six-week follow-up
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Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
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Six-week follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Enrollment Feasibility
時間枠：End-of-enrollment
|
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
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End-of-enrollment
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Enrollment Feasibility
時間枠：End-of-enrollment
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≥75% of those determined to be eligible will enroll
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End-of-enrollment
|
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Protocol Feasibility
時間枠：End-of-3-month follow-ups
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<10% missing data
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End-of-3-month follow-ups
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Protocol Feasibility
時間枠：End-of-3-month follow-ups
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≥80% 3-month follow-up retention
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End-of-3-month follow-ups
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depression Symptoms
時間枠：Six-week follow-up and 3-month follow-up
|
Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score
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Six-week follow-up and 3-month follow-up
|
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Negative Automatic Thoughts
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent report on the Negative Automatic Thoughts subscale of the Children's Automatic Thoughts Scale-Negative/Positive
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Six-week follow-up and 3-month follow-up
|
|
Pleasant Activities
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule
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Six-week follow-up and 3-month follow-up
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Homework Completion
時間枠：Six-week follow-up
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Adolescent report on the Homework Rating Scale-Version 2
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Six-week follow-up
|
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Coping
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent report on the Brief COPE inventory
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Six-week follow-up and 3-month follow-up
|
|
Self-efficacy
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent report on the Self-efficacy Questionnaire for Children
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Six-week follow-up and 3-month follow-up
|
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Loneliness
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent report on the UCLA Loneliness Scale
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Six-week follow-up and 3-month follow-up
|
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Physical Activity
時間枠：Six-week follow-up and 3-month follow-up
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Time spent in moderate-to-vigorous physical activity measured from the adolescent-worn actigraphy
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Six-week follow-up and 3-month follow-up
|
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Sedentary Time
時間枠：Six-week follow-up and 3-month follow-up
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Time spent sedentary measured from adolescent-worn actigraphy
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Six-week follow-up and 3-month follow-up
|
|
Emotional Eating
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent report on the Emotional Eating Scale-Adapted for Children and Adolescents
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Six-week follow-up and 3-month follow-up
|
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Loss-of-control Eating
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent report of loss-of-control episodes on the Loss-of-Control Eating Disorder Questionnaire for Children
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Six-week follow-up and 3-month follow-up
|
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Insulin Resistance
時間枠：Six-week follow-up and 3-month follow-up
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Homeostatic model assessment of insulin resistance derived from adolescent fasting insulin and fasting glucose
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Six-week follow-up and 3-month follow-up
|
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Blood pressure
時間枠：Six-week follow-up and 3-month follow-up
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Systolic blood pressure derived from adolescent ambulatory monitoring
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Six-week follow-up and 3-month follow-up
|
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Blood Pressure
時間枠：Six-week follow-up and 3-month follow-up
|
Diastolic blood pressure derived from adolescent ambulatory monitoring
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Six-week follow-up and 3-month follow-up
|
|
Lipids
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent triglycerides
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Six-week follow-up and 3-month follow-up
|
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Lipids
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent HDL cholesterol
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Six-week follow-up and 3-month follow-up
|
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Lipids
時間枠：Six-week follow-up and 3-month follow-up
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Adolescent LDL cholesterol
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Six-week follow-up and 3-month follow-up
|
|
Glycemic Variability
時間枠：Six-week follow-up and 3-month follow-up
|
Standard deviation of glucose derived from adolescent wear of continuous glucose monitor
|
Six-week follow-up and 3-month follow-up
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Shomaker LB, Kelly NR, Radin RM, Cassidy OL, Shank LM, Brady SM, Demidowich AP, Olsen CH, Chen KY, Stice E, Tanofsky-Kraff M, Yanovski JA. Prevention of insulin resistance in adolescents at risk for type 2 diabetes with depressive symptoms: 1-year follow-up of a randomized trial. Depress Anxiety. 2017 Oct;34(10):866-876. doi: 10.1002/da.22617. Epub 2017 Mar 31.
- Shomaker LB, Kelly NR, Pickworth CK, Cassidy OL, Radin RM, Shank LM, Vannucci A, Thompson KA, Armaiz-Flores SA, Brady SM, Demidowich AP, Galescu OA, Courville AB, Olsen C, Chen KY, Stice E, Tanofsky-Kraff M, Yanovski JA. A Randomized Controlled Trial to Prevent Depression and Ameliorate Insulin Resistance in Adolescent Girls at Risk for Type 2 Diabetes. Ann Behav Med. 2016 Oct;50(5):762-774. doi: 10.1007/s12160-016-9801-0.
- Perzow SED, Hu J, Bristol M, Ruzicka EB, Clementi MA, Handing EP, Vargas E, Gutierrez-Colina AM, Gulley LD, Shomaker LB. Systematic review and meta-analysis of psychological interventions for depression symptoms in young people with long-term physical health conditions. J Pediatr Psychol. 2025 Jul 1;50(7):699-714. doi: 10.1093/jpepsy/jsaf049.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2028年1月1日
研究の完了 (推定)
2028年8月1日
試験登録日
最初に提出
2026年4月29日
QC基準を満たした最初の提出物
2026年4月29日
最初の投稿 (実際)
2026年5月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年9月1日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-0997
- R34HL180788 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
CBT-app usage and CBT group attendance; adolescent depression questionnaire data; CBT and CBT-app adolescent questionnaires assessing CBT-group and CBT-app therapeutic targets (thoughts, pleasant activities, coping, self-efficacy, loneliness); health behavior measured by actigraphy (physical activity/sleep) and adolescent questionnaire (eating); adolescent cardiometabolic health indicators by fasting blood draw to assess lipids (triglycerides, cholesterol) and glucose/insulin to calculate insulin resistance, continuous glucose monitoring data, and heart rate/blood pressure
IPD 共有時間枠
Data will be made available no later than the time of an associated publication
IPD 共有アクセス基準
We will use the openICPSR data repository, an NIH-approved self-publishing repository for social, behavioral, and health sciences research data; to request access of the data, researchers will follow the standard process at openICPSR
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。