Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder

NCT03371810 | Completed Phase 2 DMC

• 1 other identifier: CoCA-PROUD
• Study Type: interventional
• Target: 207
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Attention-Deficit / Hyperactivity Disorder; Depression; Obesity

Keywords

attention-deficit / hyperactivity disorder; depression; obesity; prevention; bright light therapy; exercise; mobile healthy system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (35)

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

  baseline, follow up (22 weeks after baseline)

• Change from baseline in clinician-rated ADHD symptoms

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

• Change from baseline in self-reported severity of depressive symptoms

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

• Change from baseline in self-reported health status

  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

  baseline, end of intervention (10 weeks after baseline)

Study Arms (3)

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.

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.

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).

Interventions

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.

Also known as: Device: smartphone with m-Health app, Device: Philips EnergyLight HF 3419

Bright light therapy

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.

Also known as: Device: smartphone with m-Health app

Physical exercise

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Goethe University: lead
• Heidelberg University: collaborator
• Radboud University Medical Center: collaborator
• Hospital Vall d'Hebron: collaborator
• King's College London: collaborator

Study Sites (4)

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

Location

Radboud University Medical Centre, Karakter Child and Adolescent Psychiatry, and Department of Psychiatry

Nijmegen, Netherlands

Location

Vall d'Hebron Research Institute, Group of Psychiatry, Mental Health and Addiction

Barcelona, Spain

Location

King's College London, Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38627266 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.

  PMID: 29482662 DERIVED

Related Links

• Homepage of the CoCA project (Comorbid Conditions of Attention-deficit / hyperactivity disorder).The PROUD study is work package 6 of the CoCA project.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Depression; Obesity; Motor Activity

Interventions

Ultraviolet Therapy; Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christine M Freitag, Prof. Dr.

  Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital, Goethe University Frankfurt am Main

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Observer-blinded assessment of the primary outcome measure
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: December 13, 2017
• Study Start: March 13, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

NL (1); ES (1); DE (1); GB (1)