openFORT COLLINS, CO

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

National Heart Lung and Blood Institute

Description

/Abstract 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%ile for age/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. We have shown that a relatively brief, 6-week/6-session CBT-group decreased depression at post-intervention and lowered indicators of insulin resistance at 1-year follow-up among racially/ethnically diverse (70% Black/ Hispanic) adolescents (12-17y) with depression (CES-D: Center for Epidemiologic Studies-Depression Scale ≥21) and elevated BMI (≥85th%ile), compared to a time/attention-matched health education control group (K99/R00HD069516). Decreases in depression explained health benefits and were linked to increases in adolescents’ frequency/enjoyment of physical activity. However, effect sizes were small-to-moderate (Cohen’s d=.39-.61), possibly due to less-than-optimal (~60%) 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. In qualitative focus groups after CBT-group, adolescents with depression and elevated BMI express a desire for digital technology support of homework completion (R01AT011008). Few empirically- supported digital apps for depression exist for adolescents, much less adolescents with elevated BMI. Yet, our overarching rationale is that enhancement of CBT-group with a digital app is likely to strengthen translation of CBT skills to healthier coping and behavior, leading to stronger improvements in cardiometabolic health than CBT-group alone. In this NHLBI R34, we will leverage mobile health (mHealth) to adapt an existing CBT-digital app for the distinct needs/preferences of adolescents with depression and elevated BMI and optimize the app’s integration with CBT-group virtual sessions. In Phase 1, we will gather input from adolescents, caregivers, and healthcare providers through semi-structured focus group discussions (N=30), yielding an adapted app (Aim 1). In Phase 2, we will iteratively refine the app through user-centered, mixed methods input in a single-arm, open trial (N=10) of CBT+ (virtual group + adapted app), until feasibility/acceptability benchmarks are met (Aim 2). Phase 3 is a pilot randomized controlled trial of CBT+ vs. virtual CBT-group only to assess protocol/intervention feasibility/acceptability (Aim 3). An interest holder working group will work with researchers to apply feedback from diverse perspectives at all stages. Completion of the aims will provide necessary and sufficient information to proceed with a rigorous efficacy study of CBT+. This research directly aligns with NHLBI’s interest in promoting cardiovascular/cardiometabolic health in early stages of the lifecourse such as adolescence (NOT-HL-21-020). Project Number: 1R34HL180788-01 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: LAUREN SHOMAKER | Institution: COLORADO STATE UNIVERSITY, FORT COLLINS, CO | Award Amount: $226,778 | Activity Code: R34 | Study Section: NHLBI Single-Site and Pilot Clinical Trials Study Section[SSPT (MA)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R34HL18078801

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Grant Details

Funding Range

$226,778 - $226,778

Deadline

July 31, 2028

Geographic Scope

FORT COLLINS, CO

Status
open

External Links

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