Design of a randomized controlled trial to decrease depression and improve insulin sensitivity in adolescents: Mood and INsulin sensitivity to prevent Diabetes (MIND)

Contemp Clin Trials. 2018 Dec:75:19-28. doi: 10.1016/j.cct.2018.10.007. Epub 2018 Oct 17.

Abstract

Background: Depressive symptoms often manifest in adolescence and predict worsening insulin sensitivity, a key precursor in the path to β-cell failure and type 2 diabetes (T2D).

Objective: To assess the efficacy of a six-week cognitive-behavioral group versus six-week health education group for improving insulin sensitivity and preserving β-cell function in adolescent girls at-risk for T2D with depressive symptoms and evaluate mechanisms underlying the association between depression and insulin dynamics.

Design: Randomized controlled trial of N = 150 12-17-year-old girls with overweight/obesity (body mass index [BMI; kg/m2] ≥85th percentile), elevated depressive symptoms (Center for Epidemiologic Studies-Depression Scale [CES-D] total score > 20), and diabetes family history.

Methods: Girls at-risk for T2D with elevated depressive symptoms are recruited from the Denver-metropolitan area and randomized to participate in one of two six-week interventions. The cognitive-behavioral group is a depression prevention program involving psycho-education, restructuring negative thoughts, and behavioral activation. The health education group is a didactic control that provides knowledge about healthy living. Participants are assessed at baseline, immediate post-intervention, and one-year follow-up. Primary outcomes are insulin sensitivity and β-cell function from oral glucose tolerance tests. Secondary outcomes are disinhibited eating, physical activity, sleep, and cortisol.

Summary: Results from this adequately powered randomized controlled trial will determine whether decreasing depressive symptoms with a behavioral health program preventatively alters insulin sensitivity and β-cell function trajectories in adolescents at-risk for T2D. Results from the MIND Project will add to knowledge of the contribution of depressive symptoms to T2D risk.

Keywords: Adolescent; Depression; Insulin resistance; Insulin sensitivity; Type 2 diabetes.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Blood Glucose* / metabolism
  • Child
  • Cognitive Behavioral Therapy* / methods
  • Depression* / metabolism
  • Depression* / prevention & control
  • Depression* / therapy
  • Diabetes Mellitus, Type 2
  • Exercise
  • Feeding Behavior
  • Female
  • Glucose Tolerance Test
  • Humans
  • Hydrocortisone / metabolism
  • Insulin Resistance*
  • Insulin-Secreting Cells* / metabolism
  • Pediatric Obesity* / metabolism
  • Psychotherapy, Group / methods
  • Randomized Controlled Trials as Topic
  • Sleep

Substances

  • Blood Glucose
  • Hydrocortisone