Clinical trial NCT03371810: Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
Official title: Pilot Randomized-controlled Phase-IIa Trial on the Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention-Deficit / Hyperactivity Disorder
Depression
Obesity
Keywords: attention-deficit / hyperactivity disorder
depression
obesity
prevention
bright light therapy
exercise
mobile healthy system
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: Radboud University Medical Center
name: Hospital Vall d'Hebron
name: King's College London
First posted: 2017-12-13
Enrollment: 207
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, observer-blinded, controlled, multi-centre, pilot phase-IIa parallel-group design with three arms (two treatment groups and one control group); three trial phases: baseline assessment, 10 weeks of treatment versus treatment as usual; 12 weeks post-treatment observation period.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The risk for comorbid major depressive disorder and obesity is increased in adolescents and adults with attention-deficit/ hyperactivity disorder (ADHD), and adolescent ADHD predicts adults major depressive disorder and obesity. Nonpharmacological interventions to prevent these comorbidities are urgently needed. Bright light therapy (BLT) improves day-night rhythm and is an established therapy for major depression in adolescents and adults. Exercise prevents and reduces obesity in adolescents and adults and also improves depressive symptoms. Interestingly, a reinforcement-based intervention using a mobile health app (m-Health) resulted in improved effects on weightloss in obesity. The aim of the current pilot randomized-controlled phase-IIa study is to establish feasibility and effect sizes of two kinds of interventions, BLT and exercise, in combination with m-Health based monitoring and reinforcement in adolescents and young adults aged 14 to 45 years old with ADHD, targeting the prevention of depressive symptoms and obesity. In addition, immediate and long-term treatment effects on ADHD specific psychopathology, health related quality of life, fitness and body related measures, neurocognitive functions and chronotype are explored. Furthermore, saliva samples are taken in a subgroup of adult patients to explore the effects of BLT and exercise on concentrations of hormones. This subgroup of adult patients will also participate in an additional neuroimaging study of the reward system in order to explore intervention effects on striatal reward reactivity.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (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:

* Intelligence Quotient (IQ) below 75
* Any severe (comorbid) psychiatric disorder with necessary additional psychopharmaco or daycare/ inpatient therapy beyond treatment as usual
* Severe medical/ neurological condition not allowing bright light therapy or exercise
* History of epilepsy
* Use of antipsychotics, antiepileptic or photosensitising medication
* Substance abuse/ dependency

Primary outcomes:
measure: Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
timeFrame: baseline, end of intervention (10 weeks after baseline)
Secondary outcomes:
measure: Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
timeFrame: baseline, follow up (22 weeks after baseline)
measure: Change from baseline in clinician-rated ADHD symptoms
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in self-reported severity of depressive symptoms
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in self-reported health status
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in self-reported health related quality of life
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in self-reported general health status
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in self-reported emotional and behavioural problems in adolescents
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in self-reported emotional and behavioural problems in adults
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in circadian rhythm
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in cognitive emotion regulation
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in neurocognitive functions: verbal memory
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in neurocognitive functions: Digit span
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in self-reported physical fitness
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in general muscular fitness
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in muscular fitness
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in aerobic fitness
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in body mass index
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in waist circumference
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in waist-to-hip ratio
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in body fat percentage
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in heart rate
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in blood pressure
timeFrame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
measure: Change from baseline in number of steps
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in movement acceleration
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in sleep time
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in context parameters
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in mood regulation
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in reward reactivity
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in stress reactivity
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in inattention
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in melatonin concentration
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in cortisol concentration
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in leptin concentration
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in ghrelin concentration
timeFrame: baseline, end of intervention (10 weeks after baseline)
measure: Change from baseline in neural activity associated with reward processing
timeFrame: baseline, end of intervention (10 weeks after baseline)
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Goethe University Hospital Frankfurt, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, and Department of Psychiatry, Psychosomatic Medicine and Psychotherapy
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre, Karakter Child and Adolescent Psychiatry, and Department of Psychiatry
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute, Group of Psychiatry, Mental Health and Addiction
city: London
country: United Kingdom
facility: King's College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience
Study officials:
affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Goethe University Frankfurt am Main
name: Christine M Freitag, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayer JS, Hees K, Medda J, Grimm O, Asherson P, Bellina M, Colla M, Ibanez P, Koch E, Martinez-Nicolas A, Muntaner-Mas A, Rommel A, Rommelse N, de Ruiter S, Ebner-Priemer UW, Kieser M, Ortega FB, Thome J, Buitelaar JK, Kuntsi J, Ramos-Quiroga JA, Reif A, Freitag CM. Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit / hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2018 Feb 26;19(1):140. doi: 10.1186/s13063-017-2426-1.