Depression in AdolescenceCBT+NCT07569991
Digitally Enhanced Cognitive-Behavioral Therapy
A study testing Cognitive-behavioral therapy (CBT) and Digital app in people with Depression in Adolescence and Obesity & Overweight, run by Colorado State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depression in Adolescence, Obesity & Overweight, Cognitive-behavioral Therapy
- What is being tested?
- Cognitive-behavioral therapy (CBT) and Digital app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Lauren Shomaker, PhD, 1-855-395-9031, lauren.shomaker@cuanschutz.edu
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Depression in Adolescence, Obesity & Overweight, Cognitive-behavioral Therapy, Mobile Health Technology (mHealth), Health Behavior
- Being tested
- Cognitive-behavioral therapy (CBT), Digital app
- Keywords
- cognitive-behavioral therapy, depression, adolescents, cardiometabolic health, mHealth
- Medical subject headings
- Obesity, Overweight, Health Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy (CBT)Behavioural
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
Digital appBehavioural
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Cognitive-behavioral therapy (CBT) |
| 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 Receives: Behavioral: Cognitive-behavioral therapy (CBT); Behavioral: Digital app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)
Measured: Six-week follow-up
Intervention Feasibility
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
Measured: Six-week follow-up
App Acceptability
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
Measured: Six-week follow-up
Secondary outcomes (4)
Enrollment Feasibility
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
Measured: End-of-enrollment
Enrollment Feasibility
≥75% of those determined to be eligible will enroll
Measured: End-of-enrollment
Protocol Feasibility
<10% missing data
Measured: End-of-3-month follow-ups
Protocol Feasibility
≥80% 3-month follow-up retention
Measured: End-of-3-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569991
- Sponsor's protocol ID
- 25-0997
- Other IDs
- R34HL180788
- Acronym
- CBT+
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 27333897Perzow 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.
PubMed 40795045Shomaker 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.
PubMed 28370947
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Enhanced Cognitive-Behavioral Therapy for Adolescents With Depression and Obesity
- ClinicalTrials.gov ID
- NCT07569991
- Acronym / sponsor ID
- CBT+ / 25-0997
- Conditions
- Depression in Adolescence, Obesity & Overweight, Cognitive-behavioral Therapy, Mobile Health Technology (mHealth), Health Behavior
- Keywords
- cognitive-behavioral therapy, depression, adolescents, cardiometabolic health, mHealth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy (CBT) | Active comparator | Behavioral: 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 |
| Cognitive-behavioral therapy-Plus (CBT+) | Experimental | Behavioral: Cognitive-behavioral therapy (CBT), Behavioral: Digital appSix-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 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapy (CBT)Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually | Behavioural | Cognitive-behavioral therapy (CBT), Cognitive-behavioral therapy-Plus (CBT+) |
| Digital appApp tailored to support cognitive-behavioral therapy (CBT) skills and homework practices | Behavioural | Cognitive-behavioral therapy-Plus (CBT+) |
Primary outcome
Intervention Acceptability
Time frame: Six-week follow-up
≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)
Intervention Feasibility
Time frame: Six-week follow-up
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
App Acceptability
Time frame: Six-week follow-up
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
4 secondary outcomes
Enrollment Feasibility
Time frame: End-of-enrollment
Enrollment Feasibility
Time frame: End-of-enrollment
Protocol Feasibility
Time frame: End-of-3-month follow-ups
Protocol Feasibility
Time frame: End-of-3-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 27333897Shomaker 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.
- Background: PubMed 40795045Perzow 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.
- Background: PubMed 28370947Shomaker 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy (CBT) and Digital app in people with Depression in Adolescence and Obesity & Overweight, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren B Shomaker, PhD (970-491-3217, lauren.shomaker@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Acceptability (time frame: Six-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07569991, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.