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NCT Number: NCT03371810

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.

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Key information

Conditions

Attention-Deficit / Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Body Weight Depression Mental Disorders Motor Activity Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Device: smartphone with m-Health app, Device: Philips EnergyLight HF 3419

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.

Other names: Device: smartphone with m-Health app

Primary outcomes

  1. 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

  1. Change from baseline in clinician-rated depressive symptoms (observer-blinded assessment)

    Time frame: baseline, follow up (22 weeks after baseline)

    Inventory of Depressive Symptomatology (clinician-rated)

  2. Change from baseline in clinician-rated ADHD symptoms

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    ADHD Rating Scales for adults and children

  3. 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)

    Beck Depression Inventory II

  4. Change from baseline in self-reported health status

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    Health Questionnaire EQ-5D-3L

  5. Change from baseline in self-reported health related quality of life

    Time frame: baseline, end of intervention (10 weeks after baseline)

    Short Form Health Questionnaire General Health Questionnaire

  6. Change from baseline in self-reported general health status

    Time frame: baseline, end of intervention (10 weeks after baseline)

    General Health Questionnaire General Health Questionnaire

  7. 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)

    Youth self-report

  8. 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)

    Adult self-report

  9. Change from baseline in circadian rhythm

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    Munich Chronotype Questionnaire

  10. Change from baseline in cognitive emotion regulation

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    Cognitive Emotion Regulation Questionnaire

  11. Change from baseline in neurocognitive functions: verbal memory

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    Rey Auditory Verbal Learning Test

  12. Change from baseline in neurocognitive functions: Digit span

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    Digit span

  13. Change from baseline in self-reported physical fitness

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    International Fitness Scale

  14. Change from baseline in general muscular fitness

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    handgrip strength test

  15. Change from baseline in muscular fitness

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    standing long jump test

  16. Change from baseline in aerobic fitness

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    Chester step test

  17. Change from baseline in body mass index

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    body mass index measured by clinician

  18. Change from baseline in waist circumference

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    waist circumference measured by clinician

  19. Change from baseline in waist-to-hip ratio

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    waist-to-hip ratio measured by clinician

  20. Change from baseline in body fat percentage

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    based on skinfold thickness measurements using a skinfold caliper

  21. Change from baseline in heart rate

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    heart rate measured by clinician

  22. Change from baseline in blood pressure

    Time frame: baseline, end of intervention (10 weeks after baseline), follow-up (22 weeks after baseline)

    blood pressure measured by clinician

  23. Change from baseline in number of steps

    Time frame: baseline, end of intervention (10 weeks after baseline)

    number of steps measured with the mobile Health app

  24. Change from baseline in movement acceleration

    Time frame: baseline, end of intervention (10 weeks after baseline)

    movement acceleration measured with the mobile Health app

  25. Change from baseline in sleep time

    Time frame: baseline, end of intervention (10 weeks after baseline)

    sleep time measured with the mobile Health app

  26. Change from baseline in context parameters

    Time frame: baseline, end of intervention (10 weeks after baseline)

    context measured with the mobile Health

  27. Change from baseline in mood regulation

    Time frame: baseline, end of intervention (10 weeks after baseline)

    mood regulation measured with the mobile Health app

  28. Change from baseline in reward reactivity

    Time frame: baseline, end of intervention (10 weeks after baseline)

    reward reactivity measured with the mobile Health app

  29. Change from baseline in stress reactivity

    Time frame: baseline, end of intervention (10 weeks after baseline)

    stress reactivity measured with the mobile Health app

  30. Change from baseline in inattention

    Time frame: baseline, end of intervention (10 weeks after baseline)

    inattention measured with the mobile Health app

  31. Change from baseline in melatonin concentration

    Time frame: baseline, end of intervention (10 weeks after baseline)

    Saliva sample will be taken to measure melatonin concentration

  32. Change from baseline in cortisol concentration

    Time frame: baseline, end of intervention (10 weeks after baseline)

    Saliva sample will be taken to measure cortisol concentration

  33. Change from baseline in leptin concentration

    Time frame: baseline, end of intervention (10 weeks after baseline)

    Saliva sample will be taken to measure leptin concentration

  34. Change from baseline in ghrelin concentration

    Time frame: baseline, end of intervention (10 weeks after baseline)

    Saliva sample will be taken to measure ghrelin concentration

  35. Change from baseline in neural activity associated with reward processing

    Time frame: baseline, end of intervention (10 weeks after baseline)

    Striatal functional magnetic resonance imaging signal related to reward processing

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • Heidelberg University
  • Hospital Vall d'Hebron
  • King's College London
  • Radboud University Medical Center

Registry information

Official study title

Pilot Randomized-controlled Phase-IIa Trial on the Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder

Acronym: PROUD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2017
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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