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Pilot Randomized-controlled Phase-IIa Trial on the Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder

ClinicalTrials.gov · COMPLETED, 2020

207 participants

Abstract

Depression and obesity are very common among adolescents and young adults with attention-deficit/ hyperactivity disorder (ADHD). However, intervention programmes to prevent these comorbid disorders rarely exist. In a pilot randomized-controlled study we test two newly developed intervention programmes that do not involve medication: bright light therapy and physical exercise. Both interventions will be supported by a mobile Health application to monitor and feedback intervention success and booster patients' motivation.

Conditions: Attention-Deficit / Hyperactivity Disorder, Depression, Obesity.

Primary outcome: Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment).

Enrollment: 207 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 207 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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