Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder

Goethe University207 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Interventions

Bright light therapyBEHAVIORAL

Mobile therapeutic light (10.000 LUX, white light without UV light), daily (except Sunday) for 30 min in the morning or evening for 10 weeks in total at home provided by a bright light therapy device (Philips EnergyLight HF 3419). Monitoring and feedback will be realized with the m-Health system comprising of a smartphone equipped with the m-Health App, and an activity sensor equipped with a light sensor to monitor the light exposure of the participant.

Physical exerciseBEHAVIORAL

During 10 weeks participants perform three days of aerobic activities proposed and in two of these days also do muscle-strengthening exercise. Specifically, a training day consists of: (i) a 5-min warm-up period, (ii) a 10-35 min of muscle-strength training on two of the three days, (iii) a 20-40 min of aerobic training, (iii), and a 5-min of flexibility/stretching cool-down. During the course of the 10 weeks, the duration and intensity of the exercises will increase gradually. Instruction, monitoring, and feedback will be realised by the m-Health system including a smartphone equipped with the m-Health app and Secure Digital Memory cards to store the exercise videos as well as an activity sensor equipped with a mobile sensor for the acquisition of physical activity.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (4)

Goethe University Hospital Frankfurt, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, and Department of Psychiatry, Psychosomatic Medicine and Psychotherapy

Frankfurt am Main, Germany

Radboud University Medical Centre, Karakter Child and Adolescent Psychiatry, and Department of Psychiatry

Nijmegen, Netherlands

Vall d'Hebron Research Institute, Group of Psychiatry, Mental Health and Addiction

Barcelona, Spain

King's College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience

London, United Kingdom

Outcomes

Primary Outcomes

Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)

Inventory of Depressive Symptomatology (clinician-rated)

Time frame: baseline, end of intervention (10 weeks after baseline)

Secondary Outcomes

Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)

Inventory of Depressive Symptomatology (clinician-rated)

Time frame: baseline, follow up (22 weeks after baseline)

Change from baseline in clinician-rated ADHD symptoms

ADHD Rating Scales for adults and children

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in self-reported severity of depressive symptoms

Beck Depression Inventory II

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in self-reported health status

Health Questionnaire EQ-5D-3L

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in self-reported health related quality of life

Short Form Health Questionnaire General Health Questionnaire

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in self-reported general health status

General Health Questionnaire General Health Questionnaire

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in self-reported emotional and behavioural problems in adolescents

Youth self-report

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in self-reported emotional and behavioural problems in adults

Adult self-report

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in circadian rhythm

Munich Chronotype Questionnaire

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in cognitive emotion regulation

Cognitive Emotion Regulation Questionnaire

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in neurocognitive functions: verbal memory

Rey Auditory Verbal Learning Test

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in neurocognitive functions: Digit span

Digit span

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in self-reported physical fitness

International Fitness Scale

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in general muscular fitness

handgrip strength test

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in muscular fitness

standing long jump test

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in aerobic fitness

Chester step test

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in body mass index

body mass index measured by clinician

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in waist circumference

waist circumference measured by clinician

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in waist-to-hip ratio

waist-to-hip ratio measured by clinician

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in body fat percentage

based on skinfold thickness measurements using a skinfold caliper

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in heart rate

heart rate measured by clinician

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in blood pressure

blood pressure measured by clinician

Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

Change from baseline in number of steps

number of steps measured with the mobile Health app

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in movement acceleration

movement acceleration measured with the mobile Health app

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in sleep time

sleep time measured with the mobile Health app

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in context parameters

context measured with the mobile Health

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in mood regulation

mood regulation measured with the mobile Health app

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in reward reactivity

reward reactivity measured with the mobile Health app

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in stress reactivity

stress reactivity measured with the mobile Health app

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in inattention

inattention measured with the mobile Health app

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in melatonin concentration

Saliva sample will be taken to measure melatonin concentration

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in cortisol concentration

Saliva sample will be taken to measure cortisol concentration

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in leptin concentration

Saliva sample will be taken to measure leptin concentration

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in ghrelin concentration

Saliva sample will be taken to measure ghrelin concentration

Time frame: baseline, end of intervention (10 weeks after baseline)

Change from baseline in neural activity associated with reward processing

Striatal functional magnetic resonance imaging signal related to reward processing

Time frame: baseline, end of intervention (10 weeks after baseline)

Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes