Trial results for a study investigating a mindfulness-based intervention for depression and insulin resistance in adolescents were posted on ClinicalTrials.gov on 2026-04-02, with 120 participants enrolled.
Background
Rates of type 2 diabetes (T2D) in adolescents have escalated, with adolescent-onset T2D associated with greater health comorbidities and shorter life expectancy than adult-onset. T2D is preventable by decreasing insulin resistance, a physiological precursor to the condition. While the standard-of-care for T2D prevention involves lifestyle intervention to decrease insulin resistance through weight loss, this approach has shown insufficient effectiveness in adolescents. Furthermore, adolescents at risk for T2D frequently experience depression, which is known to predict worsening insulin resistance and T2D onset, even independently of obesity. This highlights the need for effective interventions that address both metabolic and mental health aspects in this vulnerable population.
Trial design
This completed study, designated as Phase NA, enrolled 120 participants to investigate conditions including Type 2 Diabetes, Depression, Insulin Resistance, Obesity, and Adolescent Development. The trial explored various interventions, including a Mindfulness-Based Intervention, Cognitive-Behavioral Therapy, and Health Education, focusing on their feasibility and fidelity in an adolescent population.
Key results
The trial reported several key measurements related to intervention and training fidelity, as well as recruitment feasibility:
- Intervention Fidelity (Expert ratings ranging from 0-100%):
- For the Mindfulness-Based Intervention, median ratings were 90% and 100%.
- For Cognitive-Behavioral Therapy, median ratings were 90% and 90.5%.
- For Health Education, median ratings were 97.5% and 96%.
- Recruitment Feasibility: Percentage of Eligible Adolescents Who Enroll:
- A total of 120 adolescents enrolled in the study.
- Training Fidelity: Facilitator Knowledge After Training (Participants):
- For the Mindfulness-Based Intervention group, 11 facilitators were assessed.
- For the Cognitive-Behavioral Therapy group, 10 facilitators were assessed.
- For the Health Education group, 9 facilitators were assessed.
- Training Fidelity: Facilitator Adherence and Competence During Mock Sessions (Expert ratings ranging from 0-100%):
- For the Mindfulness-Based Intervention, the median rating was 80%.
- For Cognitive-Behavioral Therapy, the median rating was 86%.
What this means
The posted results indicate successful recruitment, with 120 adolescents enrolling in the study. High levels of intervention fidelity were observed across the Mindfulness-Based Intervention, Cognitive-Behavioral Therapy, and Health Education groups, as evidenced by expert ratings. Similarly, facilitator training fidelity was also reported. These findings suggest that implementing such interventions and training facilitators for them is feasible within an adolescent population facing risks of depression and type 2 diabetes. While these results do not include efficacy data, they provide crucial insights into the operational viability of these approaches, laying groundwork for future studies to assess clinical outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study "Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents" were posted on 2026-04-02 on clinicaltrials.gov.