Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)
2026년 9월 1일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Lauren B Shomaker, PhD
- 전화번호: 970-491-3217
- 이메일: lauren.shomaker@colostate.edu
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045
- University of Colorado Anschutz Medical Campus
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연락하다:
- Lauren Shomaker, PhD
- 전화번호: 1-855-395-9031
- 이메일: lauren.shomaker@cuanschutz.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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
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Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
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|
실험적: 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
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Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Intervention Acceptability
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Enrollment Feasibility
기간: End-of-enrollment
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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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depression Symptoms
기간: 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
기간: 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
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Pleasant Activities
기간: 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
기간: 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
기간: 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
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Self-efficacy
기간: 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
|
|
Loneliness
기간: 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
기간: 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
기간: 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
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Emotional Eating
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
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Lipids
기간: 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
기간: 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
기간: 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
|
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Glycemic Variability
기간: Six-week follow-up and 3-month follow-up
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Standard deviation of glucose derived from adolescent wear of continuous glucose monitor
|
Six-week follow-up and 3-month follow-up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 1일
기본 완료 (추정된)
2028년 1월 1일
연구 완료 (추정된)
2028년 8월 1일
연구 등록 날짜
최초 제출
2026년 4월 29일
QC 기준을 충족하는 최초 제출
2026년 4월 29일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 1일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-0997
- R34HL180788 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Data will be made available no later than the time of an associated publication
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .