A Phase 2 interventional study of Bright light therapy and Physical exercise in Attention-Deficit / Hyperactivity Disorder, Depression and Obesity, sponsored by Goethe University. Completed at 4 sites in 4 countries. Open to participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Goethe University · Phase 2, Interventional, and Prevention
Among 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany — 2 open to participants now, 2 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · Germany.
Among the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany, this one is the 21st largest by enrollment of the 55 interventional ones that give a count, is the only one that started in 2017, is one of 3 in phase 2, and was the 48th registered.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
Browse Attention Deficit Disorder with Hyperactivity studies →2 of the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany are open now. Recruiting first, the newest first:
Prof. Dr. Frank Behrens · Sites in Germany
Bielefeld University · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.
This study: 14 Years to 45 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
63 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 23 · Phase 4 8
First in 2000; this study’s year is marked. 1 started in 2017.
This study's enrollment of 207 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Median enrollment 150 across the 55 interventional studies, 434 across the 8 observational. Of the 52 that completed or were terminated, 20 (38%) have results posted.
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33 of 63 have an industry lead sponsor. The 10 most frequent:
Goethe University is the lead sponsor of 98 studies on the registry; 15 are open to participants now.
Goethe University has 1 study filed under Attention Deficit Disorder with Hyperactivity — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 63 studies in Attention Deficit Disorder with Hyperactivity with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Bright light therapy
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.
Behavioral: Physical exercise
Stable treatment as usual comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of bright light therapy or exercise).
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.
Also known as: Device: smartphone with m-Health app, Device: Philips EnergyLight HF 3419
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.
Also known as: Device: smartphone with m-Health app
Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
Inventory of Depressive Symptomatology (clinician-rated)
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)
Inventory of Depressive Symptomatology (clinician-rated)
Time frame: baseline, follow up (22 weeks after baseline)
Change from baseline in clinician-rated ADHD symptoms
ADHD Rating Scales for adults and children
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
Beck Depression Inventory II
Time frame: 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
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
Short Form Health Questionnaire General Health Questionnaire
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in self-reported general health status
General Health Questionnaire General Health Questionnaire
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in self-reported emotional and behavioural problems in adolescents
Youth self-report
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
Adult self-report
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in circadian rhythm
Munich Chronotype Questionnaire
Time frame: 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
Time frame: 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
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in neurocognitive functions: Digit span
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
International Fitness Scale
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in general muscular fitness
handgrip strength test
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in muscular fitness
standing long jump test
Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)
Change from baseline in aerobic fitness
Chester step test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in movement acceleration
movement acceleration measured with the mobile Health app
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in sleep time
sleep time measured with the mobile Health app
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in context parameters
context measured with the mobile Health
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in mood regulation
mood regulation measured with the mobile Health app
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in reward reactivity
reward reactivity measured with the mobile Health app
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in stress reactivity
stress reactivity measured with the mobile Health app
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in inattention
inattention measured with the mobile Health app
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in melatonin concentration
Saliva sample will be taken to measure melatonin concentration
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in cortisol concentration
Saliva sample will be taken to measure cortisol concentration
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in leptin concentration
Saliva sample will be taken to measure leptin concentration
Time frame: baseline, end of intervention (10 weeks after baseline)
Change from baseline in ghrelin concentration
Saliva sample will be taken to measure ghrelin concentration
Time frame: 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
Time frame: baseline, end of intervention (10 weeks after baseline)
Plan to share: Undecided
Ran from Mar 2017 to primary completion in Aug 2020, 41 months.
Of 40 phase 2 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 41 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity →
Goethe University