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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03371810
Other study ID # CoCA-PROUD
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 13, 2017
Est. completion date August 31, 2020

Study information

Verified date October 2020
Source Goethe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 207
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 14 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Bright 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.
Physical 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.

Locations

Country Name City State
Germany Goethe University Hospital Frankfurt, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, and Department of Psychiatry, Psychosomatic Medicine and Psychotherapy Frankfurt am Main
Netherlands Radboud University Medical Centre, Karakter Child and Adolescent Psychiatry, and Department of Psychiatry Nijmegen
Spain Vall d'Hebron Research Institute, Group of Psychiatry, Mental Health and Addiction Barcelona
United Kingdom King's College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience London

Sponsors (5)

Lead Sponsor Collaborator
Goethe University Heidelberg University, Hospital Vall d'Hebron, King's College London, Radboud University

Countries where clinical trial is conducted

Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment) Inventory of Depressive Symptomatology (clinician-rated) baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment) Inventory of Depressive Symptomatology (clinician-rated) baseline, follow up (22 weeks after baseline)
Secondary Change from baseline in clinician-rated ADHD symptoms ADHD Rating Scales for adults and children baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in self-reported severity of depressive symptoms Beck Depression Inventory II baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in self-reported health status Health Questionnaire EQ-5D-3L baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in self-reported health related quality of life Short Form Health Questionnaire General Health Questionnaire baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in self-reported general health status General Health Questionnaire General Health Questionnaire baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in self-reported emotional and behavioural problems in adolescents Youth self-report baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in self-reported emotional and behavioural problems in adults Adult self-report baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in circadian rhythm Munich Chronotype Questionnaire baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in cognitive emotion regulation Cognitive Emotion Regulation Questionnaire baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in neurocognitive functions: verbal memory Rey Auditory Verbal Learning Test baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in neurocognitive functions: Digit span Digit span baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in self-reported physical fitness International Fitness Scale baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in general muscular fitness handgrip strength test baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in muscular fitness standing long jump test baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in aerobic fitness Chester step test baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in body mass index body mass index measured by clinician baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in waist circumference waist circumference measured by clinician baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in waist-to-hip ratio waist-to-hip ratio measured by clinician baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in body fat percentage based on skinfold thickness measurements using a skinfold caliper baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in heart rate heart rate measured by clinician baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in blood pressure blood pressure measured by clinician baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Secondary Change from baseline in number of steps number of steps measured with the mobile Health app baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in movement acceleration movement acceleration measured with the mobile Health app baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in sleep time sleep time measured with the mobile Health app baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in context parameters context measured with the mobile Health baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in mood regulation mood regulation measured with the mobile Health app baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in reward reactivity reward reactivity measured with the mobile Health app baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in stress reactivity stress reactivity measured with the mobile Health app baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in inattention inattention measured with the mobile Health app baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in melatonin concentration Saliva sample will be taken to measure melatonin concentration baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in cortisol concentration Saliva sample will be taken to measure cortisol concentration baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in leptin concentration Saliva sample will be taken to measure leptin concentration baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in ghrelin concentration Saliva sample will be taken to measure ghrelin concentration baseline, end of intervention (10 weeks after baseline)
Secondary Change from baseline in neural activity associated with reward processing Striatal functional magnetic resonance imaging signal related to reward processing baseline, end of intervention (10 weeks after baseline)
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