Pilot Randomized-controlled Phase-IIa Trial on the Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Attention-Deficit / Hyperactivity Disorder
- Sponsor
- Goethe University
- Enrollment
- 207
- Locations
- 4
- Primary Endpoint
- Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Christine M. Freitag
Prof. Dr.
Goethe University
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
Outcomes
Primary Outcomes
Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
Time Frame: baseline, end of intervention (10 weeks after baseline)
Inventory of Depressive Symptomatology (clinician-rated)
Secondary Outcomes
- Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)(baseline, follow up (22 weeks after baseline))
- Change from baseline in clinician-rated ADHD symptoms(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in self-reported severity of depressive symptoms(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in self-reported health status(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(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in self-reported general health status(baseline, end of intervention (10 weeks after baseline))
- 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))
- 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))
- Change from baseline in circadian rhythm(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in cognitive emotion regulation(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in neurocognitive functions: verbal memory(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in neurocognitive functions: Digit span(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in self-reported physical fitness(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in body mass index(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in general muscular fitness(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in muscular fitness(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in aerobic fitness(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in waist circumference(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in waist-to-hip ratio(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in body fat percentage(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in heart rate(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in blood pressure(baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline))
- Change from baseline in number of steps(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in movement acceleration(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in sleep time(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in context parameters(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in mood regulation(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in reward reactivity(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in stress reactivity(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in inattention(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in melatonin concentration(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in cortisol concentration(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in neural activity associated with reward processing(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in leptin concentration(baseline, end of intervention (10 weeks after baseline))
- Change from baseline in ghrelin concentration(baseline, end of intervention (10 weeks after baseline))