Attention-Deficit / Hyperactivity DisorderPhase 2PROUDNCT03371810
Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
A Phase 2 study testing Bright light therapy and Physical exercise in people with Attention-Deficit / Hyperactivity Disorder and Depression, run by Goethe University at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Attention-Deficit / Hyperactivity Disorder, Depression, Obesity
- What is being tested?
- Bright light therapy and Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 13 Mar 2017to 31 Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Germany1 site
Goethe University Hospital Frankfurt, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, and Department of Psychiatry, Psychosomatic Medicine and Psychotherapy
Frankfurt am Main
Netherlands1 site
Radboud University Medical Centre, Karakter Child and Adolescent Psychiatry, and Department of Psychiatry
Nijmegen
Spain1 site
Vall d'Hebron Research Institute, Group of Psychiatry, Mental Health and Addiction
Barcelona
United Kingdom1 site
King's College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience
London
About this study
Official title: Pilot Randomized-controlled Phase-IIa Trial on the Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
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.
Read the 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.
- Being tested
- Bright light therapy, Physical exercise
- Keywords
- attention-deficit / hyperactivity disorder, depression, obesity, prevention, bright light therapy, exercise, mobile healthy system
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Depression, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright light therapyBehavioural
Also called Device: smartphone with m-Health app, Device: Philips EnergyLight HF 3419
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 exerciseBehavioural
Also called Device: smartphone with m-Health app
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Bright light therapy |
| 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. Receives: Behavioral: Physical exercise |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
Inventory of Depressive Symptomatology (clinician-rated)
Measured: baseline, end of intervention (10 weeks after baseline)
Secondary outcomes (35)
Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
Inventory of Depressive Symptomatology (clinician-rated)
Measured: baseline, follow up (22 weeks after baseline)
Change from baseline in clinician-rated ADHD symptoms
ADHD Rating Scales for adults and children
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in self-reported general health status
General Health Questionnaire General Health Questionnaire
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in self-reported emotional and behavioural problems in adolescents
Youth self-report
Measured: 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
Measured: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in circadian rhythm
Munich Chronotype Questionnaire
Measured: 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
Measured: 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
Measured: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in neurocognitive functions: Digit span
Digit span
Measured: 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
Measured: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in general muscular fitness
handgrip strength test
Measured: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in muscular fitness
standing long jump test
Measured: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in aerobic fitness
Chester step test
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in movement acceleration
movement acceleration measured with the mobile Health app
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in sleep time
sleep time measured with the mobile Health app
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in context parameters
context measured with the mobile Health
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in mood regulation
mood regulation measured with the mobile Health app
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in reward reactivity
reward reactivity measured with the mobile Health app
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in stress reactivity
stress reactivity measured with the mobile Health app
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in inattention
inattention measured with the mobile Health app
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in melatonin concentration
Saliva sample will be taken to measure melatonin concentration
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in cortisol concentration
Saliva sample will be taken to measure cortisol concentration
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in leptin concentration
Saliva sample will be taken to measure leptin concentration
Measured: baseline, end of intervention (10 weeks after baseline)
Change from baseline in ghrelin concentration
Saliva sample will be taken to measure ghrelin concentration
Measured: 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
Measured: baseline, end of intervention (10 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start13 Mar 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit / Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Radboud University Medical Center, Hospital Vall d'Hebron, King's College London
- Responsible party
- Principal investigator, Christine M. Freitag, Goethe University
- Investigators
- Christine M Freitag, Prof. Dr., Principal investigator, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Goethe University Frankfurt am Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371810
- Sponsor's protocol ID
- CoCA-PROUD
- Acronym
- PROUD
- Status last verified
- Oct 2020
- First submitted
- 3 Mar 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38627266Mayer 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.
PubMed 29482662
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized-controlled Phase-IIa Trial on the Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03371810
- Acronym / sponsor ID
- PROUD / CoCA-PROUD
- Keywords
- attention-deficit / hyperactivity disorder, depression, obesity, prevention, bright light therapy, exercise, mobile healthy system
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Heidelberg University, Radboud University Medical Center, Hospital Vall d'Hebron, King's College London
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bright light therapy | Experimental | Behavioral: Bright light therapyMobile 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 | Behavioral: Physical exerciseAerobic 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). |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright light therapyAlso: Device: smartphone with m-Health app, Device: Philips EnergyLight HF 3419Mobile 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. | Behavioural | Bright light therapy |
| Physical exerciseAlso: Device: smartphone with m-Health appDuring 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. | Behavioural | Physical exercise |
Primary outcome
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)
35 secondary outcomes
Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
Time frame: baseline, follow up (22 weeks after baseline)
Change from baseline in clinician-rated ADHD symptoms
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in self-reported severity of depressive symptoms
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in self-reported health status
Time frame: 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
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in self-reported general health status
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in self-reported emotional and behavioural problems in adolescents
Time frame: 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
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in circadian rhythm
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in cognitive emotion regulation
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in neurocognitive functions: verbal memory
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in neurocognitive functions: Digit span
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in self-reported physical fitness
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in general muscular fitness
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in muscular fitness
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in aerobic fitness
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in body mass index
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in waist circumference
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in waist-to-hip ratio
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in body fat percentage
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in heart rate
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in blood pressure
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in number of steps
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in movement acceleration
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in sleep time
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in context parameters
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in mood regulation
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in reward reactivity
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in stress reactivity
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in inattention
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in melatonin concentration
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in cortisol concentration
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in leptin concentration
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in ghrelin concentration
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in neural activity associated with reward processing
Time frame: baseline, end of intervention (10 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 38627266Mayer 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.
- Derived from this study: PubMed 29482662Mayer 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.
- Homepage of the CoCA project (Comorbid Conditions of Attention-deficit / hyperactivity disorder).The PROUD study is work package 6 of the CoCA project.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine M Freitag, Prof. Dr. principal investigator
Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Goethe University Frankfurt am Main
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bright light therapy and Physical exercise in people with Attention-Deficit / Hyperactivity Disorder and Depression, run by Goethe University at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment) (time frame: baseline, end of intervention (10 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371810, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.