Digitally Enhanced Cognitive-Behavioral Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorColorado State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive-behavioral therapy (CBT)

    Behavioral

    Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually

  • Digital app

    Behavioral

    App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cognitive-behavioral therapy (CBT)Active comparator 1 intervention
Group B: Cognitive-behavioral therapy-Plus (CBT+)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Intervention Acceptability

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

Time frame
Six-week follow-up
2

Intervention Feasibility

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

Time frame
Six-week follow-up
3

App Acceptability

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

Time frame
Six-week follow-up

Secondary outcomes

1

Enrollment Feasibility

10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts

Time frame
End-of-enrollment
2

Enrollment Feasibility

≥75% of those determined to be eligible will enroll

Time frame
End-of-enrollment
3

Protocol Feasibility

\<10% missing data

Time frame
End-of-3-month follow-ups
4

Protocol Feasibility

≥80% 3-month follow-up retention

Time frame
End-of-3-month follow-ups

Other outcomes

1

Depression Symptoms

Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score

Time frame
Six-week follow-up and 3-month follow-up
2

Negative Automatic Thoughts

Adolescent report on the Negative Automatic Thoughts subscale of the Children's Automatic Thoughts Scale-Negative/Positive

Time frame
Six-week follow-up and 3-month follow-up
3

Pleasant Activities

Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule

Time frame
Six-week follow-up and 3-month follow-up
4

Homework Completion

Adolescent report on the Homework Rating Scale-Version 2

Time frame
Six-week follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colorado State University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: