Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Heidelberg University | OTHER |
| Radboud University Medical Center | OTHER |
| Hospital Vall d'Hebron | OTHER |
| King's College London |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright light therapy | Experimental | 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 | Experimental | 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. |
|
| Treatment as usual | No Intervention | Stable treatment as usual comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of bright light therapy or exercise). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright light therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment) | Inventory of Depressive Symptomatology (clinician-rated) | baseline, follow up (22 weeks after baseline) |
| Change from baseline in clinician-rated ADHD symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine M Freitag, Prof. Dr. | Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Goethe University Frankfurt am Main | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38627266 | Derived | Mayer JS, Kohlhas L, Stermann J, Medda J, Brandt GA, Grimm O, Pawley AD, Asherson P, Sanchez JP, Richarte V, Bergsma D, Koch ED, Muntaner-Mas A, Ebner-Priemer UW, Kieser M, Retz W, Ortega FB, Colla M, Buitelaar JK, Kuntsi J, Ramos-Quiroga JA, Reif A, Freitag CM. Bright light therapy versus physical exercise to prevent co-occurring depression in adolescents and young adults with attention-deficit/hyperactivity disorder: a multicentre, three-arm, randomised controlled, pilot phase-IIa trial. Eur Arch Psychiatry Clin Neurosci. 2025 Apr;275(3):653-665. doi: 10.1007/s00406-024-01784-1. Epub 2024 Apr 16. | |
| 29482662 |
| Label | URL |
|---|---|
| Homepage of the CoCA project (Comorbid Conditions of Attention-deficit / hyperactivity disorder).The PROUD study is work package 6 of the CoCA project. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D003863 | Depression |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D009043 | Motor Activity |
| D009068 | Movement |
Not provided
Not provided
| OTHER |
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.
Not provided
Not provided
Observer-blinded assessment of the primary outcome measure
|
|
| Physical exercise | Behavioral | 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. |
|
|
ADHD Rating Scales for adults and children
| 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 | 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 | 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 | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in self-reported general health status | General Health Questionnaire General Health Questionnaire | baseline, end of intervention (10 weeks after baseline) |
| 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) |
| 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) |
| Change from baseline in circadian rhythm | Munich Chronotype Questionnaire | 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 | 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 | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) |
| Change from baseline in neurocognitive functions: Digit span | Digit span | 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 | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) |
| Change from baseline in general muscular fitness | handgrip strength test | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) |
| Change from baseline in muscular fitness | standing long jump test | baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline) |
| Change from baseline in aerobic fitness | Chester step test | 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 | 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 | 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 | 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 | 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 | 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 | 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 | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in movement acceleration | movement acceleration measured with the mobile Health app | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in sleep time | sleep time measured with the mobile Health app | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in context parameters | context measured with the mobile Health | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in mood regulation | mood regulation measured with the mobile Health app | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in reward reactivity | reward reactivity measured with the mobile Health app | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in stress reactivity | stress reactivity measured with the mobile Health app | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in inattention | inattention measured with the mobile Health app | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in melatonin concentration | Saliva sample will be taken to measure melatonin concentration | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in cortisol concentration | Saliva sample will be taken to measure cortisol concentration | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in leptin concentration | Saliva sample will be taken to measure leptin concentration | baseline, end of intervention (10 weeks after baseline) |
| Change from baseline in ghrelin concentration | Saliva sample will be taken to measure ghrelin concentration | 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 | baseline, end of intervention (10 weeks after baseline) |
| 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 |
| Derived |
| Mayer JS, Hees K, Medda J, Grimm O, Asherson P, Bellina M, Colla M, Ibanez P, Koch E, Martinez-Nicolas A, Muntaner-Mas A, Rommel A, Rommelse N, de Ruiter S, Ebner-Priemer UW, Kieser M, Ortega FB, Thome J, Buitelaar JK, Kuntsi J, Ramos-Quiroga JA, Reif A, Freitag CM. Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit / hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2018 Feb 26;19(1):140. doi: 10.1186/s13063-017-2426-1. |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |