Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
- Conditions
- ObesityDepressionAttention-Deficit / Hyperactivity Disorder
- Interventions
- Behavioral: Bright light therapyBehavioral: Physical exercise
- Registration Number
- NCT03371810
- Lead Sponsor
- Goethe University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bright light therapy Bright light therapy Mobile therapeutic light (10.000 LUX), daily (except Sunday) for 30 min in the morning or evening for 10 weeks in total. Additional treatment as usual comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of bright light therapy or exercise) is allowed. Physical exercise Physical exercise Aerobic exercise of moderate-to-vigorous intensity three days a week plus muscle-strengthening exercises two days a week during 10 weeks in total. Additional treatment as usual comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of bright light therapy or exercise) is allowed.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 circadian rhythm baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) Munich Chronotype Questionnaire
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 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
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 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 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
Trial Locations
- Locations (4)
King's College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience
🇬🇧London, United Kingdom
Radboud University Medical Centre, Karakter Child and Adolescent Psychiatry, and Department of Psychiatry
🇳🇱Nijmegen, Netherlands
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
Vall d'Hebron Research Institute, Group of Psychiatry, Mental Health and Addiction
🇪🇸Barcelona, Spain