Attention-Deficit / Hyperactivity Disorder, Depression, Obesity
Conditions
Keywords
attention-deficit / hyperactivity disorder, depression, obesity, prevention, bright light therapy, exercise, mobile healthy system
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.
Interventions
BEHAVIORALBright light therapy
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.
BEHAVIORALPhysical exercise
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.
Sponsors
Heidelberg University
Radboud University Medical Center
Hospital Vall d'Hebron
King's College London
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Observer-blinded assessment of the primary outcome measure
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment) | baseline, end of intervention (10 weeks after baseline) | Inventory of Depressive Symptomatology (clinician-rated) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in self-reported emotional and behavioural problems in adults | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Adult self-report |
| Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment) | baseline, follow up (22 weeks after baseline) | Inventory of Depressive Symptomatology (clinician-rated) |
| Change from baseline in clinician-rated ADHD symptoms | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | ADHD Rating Scales for adults and children |
| Change from baseline in self-reported severity of depressive symptoms | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Beck Depression Inventory II |
| Change from baseline in self-reported health status | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Health Questionnaire EQ-5D-3L |
| Change from baseline in self-reported health related quality of life | baseline, end of intervention (10 weeks after baseline) | Short Form Health Questionnaire General Health Questionnaire |
| Change from baseline in self-reported general health status | baseline, end of intervention (10 weeks after baseline) | General Health Questionnaire General Health Questionnaire |
| Change from baseline in self-reported emotional and behavioural problems in adolescents | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Youth self-report |
| Change from baseline in cognitive emotion regulation | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Cognitive Emotion Regulation Questionnaire |
| Change from baseline in neurocognitive functions: verbal memory | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Rey Auditory Verbal Learning Test |
| Change from baseline in neurocognitive functions: Digit span | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Digit span |
| Change from baseline in self-reported physical fitness | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | International Fitness Scale |
| Change from baseline in general muscular fitness | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | handgrip strength test |
| Change from baseline in muscular fitness | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | standing long jump test |
| Change from baseline in aerobic fitness | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Chester step test |
| Change from baseline in body mass index | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | body mass index measured by clinician |
| Change from baseline in waist circumference | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | waist circumference measured by clinician |
| Change from baseline in circadian rhythm | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | Munich Chronotype Questionnaire |
| Change from baseline in body fat percentage | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | based on skinfold thickness measurements using a skinfold caliper |
| Change from baseline in heart rate | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | heart rate measured by clinician |
| Change from baseline in blood pressure | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | blood pressure measured by clinician |
| Change from baseline in number of steps | baseline, end of intervention (10 weeks after baseline) | number of steps measured with the mobile Health app |
| Change from baseline in movement acceleration | baseline, end of intervention (10 weeks after baseline) | movement acceleration measured with the mobile Health app |
| Change from baseline in sleep time | baseline, end of intervention (10 weeks after baseline) | sleep time measured with the mobile Health app |
| Change from baseline in context parameters | baseline, end of intervention (10 weeks after baseline) | context measured with the mobile Health |
| Change from baseline in mood regulation | baseline, end of intervention (10 weeks after baseline) | mood regulation measured with the mobile Health app |
| Change from baseline in reward reactivity | baseline, end of intervention (10 weeks after baseline) | reward reactivity measured with the mobile Health app |
| Change from baseline in stress reactivity | baseline, end of intervention (10 weeks after baseline) | stress reactivity measured with the mobile Health app |
| Change from baseline in inattention | baseline, end of intervention (10 weeks after baseline) | inattention measured with the mobile Health app |
| Change from baseline in melatonin concentration | baseline, end of intervention (10 weeks after baseline) | Saliva sample will be taken to measure melatonin concentration |
| Change from baseline in cortisol concentration | baseline, end of intervention (10 weeks after baseline) | Saliva sample will be taken to measure cortisol concentration |
| Change from baseline in leptin concentration | baseline, end of intervention (10 weeks after baseline) | Saliva sample will be taken to measure leptin concentration |
| Change from baseline in ghrelin concentration | baseline, end of intervention (10 weeks after baseline) | Saliva sample will be taken to measure ghrelin concentration |
| Change from baseline in neural activity associated with reward processing | baseline, end of intervention (10 weeks after baseline) | Striatal functional magnetic resonance imaging signal related to reward processing |
| Change from baseline in waist-to-hip ratio | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) | waist-to-hip ratio measured by clinician |
Countries
Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed