Pilot randomized-controlled phase-IIa trial on the prevention of comorbid depression and obesity in attention-deficit/ hyperactivity disorder

Phase 2

• Conditions: F90.0; F90.1; F98.8; F32; E66; Disturbance of activity and attention; Hyperkinetic conduct disorder; Other specified behavioural and emotional disorders with onset usually occurring in childhood and adolescence; Depressive episode; Obesity

• Registration Number: DRKS00011666
• Lead Sponsor: Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum Frankfurt am Main

Brief Summary

Depression is common in attention-defcit/hyperactivity disorder (ADHD), but preventive behavioural interventions are lacking. This randomised controlled, pilot phase-IIa trial aimed to study a physical exercise intervention (EI) and bright light therapy (BLT)—both implemented and monitored in an individual, naturalistic setting via a mobile health (m-health) system—for feasibility of trial design and interventions, and to estimate their efects on depressive symptoms in young people with ADHD. Two hundred seven participants aged 14–45 years were randomised to 10-week add-on intervention of either BLT (10,000 lx; daily 30-min sessions) (n=70), EI (aerobic and muscle-strengthening activities 3 days/ week) (n=69), or treatment-as-usual (TAU) (n=68), of whom 165 (80%) were retained (BLT: n=54; EI: n=52; TAU: n=59). Intervention adherence (i.e.= 80% completed sessions) was very low for both BLT (n=13, 22%) and EI (n=4, 7%). Usability of the m-health system to conduct interventions was limited as indicated by objective and subjective data. Safety was high and comparable between groups. Changes in depressive symptoms (assessed via observer-blind ratings, Inventory of Depressive Symptomatology) between baseline and end of intervention were small (BLT: -0.124 [95% CI: -2.219, 1.971], EI: -2.646 [95% CI: -4.777, -0.515], TAU: -1.428 [95% CI: -3.381, 0.526]) with no group differences [F(2,153)=1.45, p=0.2384]. These fndings suggest that the m-health approach did not achieve feasibility of EI and BLT in young people with ADHD. Prior to designing efcacy studies, strategies how to achieve high intervention adherence should be specifcally investigated in this patient group.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-09
• Study Completion: 2020-08-31
• Results First Posted: 2024-04-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Diagnosis of ADHD according to DSM-5 criteria
Stable treatment as usual comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of bright light therapy or exercise)

Exclusion Criteria

IQ below 75
Any severe (comorbid) psychiatric disorder with necessary additional psychopharmaco- or day-care/inpatient therapy beyond treatment of usual
Severe medical/ neurological condition not allowing bright light therapy or exercise
History of epilepsy
Use of antipsychotics, anti-epileptic or photosensitising medication
Substance abuse/ dependency

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Inventory of Depressive Symptomatology (IDS-C30) total score (observer-blinded assessment) between baseline and end of intervention