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Pilot randomized-controlled phase-IIa trial on the prevention of comorbid depression and obesity in attention-deficit/ hyperactivity disorder

Pilot randomized-controlled phase-IIa trial on the prevention of comorbid depression and obesity in attention-deficit/ hyperactivity disorder - CoCA-PROUD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011666
Enrollment
330
Registered
2017-02-09
Start date
2017-03-13
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F90.0 F90.1 F98.8 F32 E66

Interventions

Group 1: Treatment group 1: Exercise intervention Aerobic exercise of moderate-to-vigorous intensity three days a week plus muscle-strengthening exercises two days a week during 10 weeks in total. Add

Sponsors

Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum Frankfurt am Main
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 45 Years

Inclusion criteria

Inclusion criteria: Diagnosis of ADHD according to 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

Exclusion criteria: IQ below 75 Any severe (comorbid) psychiatric disorder with necessary additional psychopharmaco- or day-care/inpatient therapy beyond treatment of usual Severe medical/ neurological condition not allowing bright light therapy or exercise History of epilepsy Use of antipsychotics, anti-epileptic or photosensitising medication Substance abuse/ dependency

Design outcomes

Primary

MeasureTime frame
Change in the Inventory of Depressive Symptomatology (IDS-C30) total score (observer-blinded assessment) between baseline and end of intervention

Secondary

MeasureTime frame
Parameters assessed at baseline, at the end of the interventions, and at 12 weeks follow-up: - Clinician-rated ADHD symptoms (ADHD Rating Scales for adults and children) - Self-reported severity of depressive symptoms (Beck Depression Inventory II) - Self-reported health status and health related quality of life (Health Questionnaire EQ-5D-3L, General Health Questionnaire) - Self-reported emotional and behavioural problems (Youth self-report, Adult self-report) - Circadian rhythm (Munique Chronotype Questionnaire) - Neurocognitive functions (Cognitive Emotion Regulation Questionnaire, Rey Auditory Verbal Learning Test, Digit span) - Physical fitness (International Fitness Scale, fitness tests) - Body composition parameters - Heart rate and blood pressure - Clinician rated depressive symptoms (Inventory of Depressive Symptomatology, observer-blinded assessment, based on interview) between baseline and 12 weeks follow-up Parameters assessed at baseline and at the end of the interventions: - Short Form Health Questionnaire - Parameters measured with the mobile Health app: number of steps, movement acceleration, sleep time, context, mood regulation, reward/ stress reactivity, inattention - Concentrations of hormones - Additional neuroimaging study: Striatal fMRI signal related to reward processing

Countries

Germany, Netherlands, Spain, United Kingdom

Contacts

Public ContactJutta Mayer

Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum Frankfurt am Main

mayer@psych.uni-frankfurt.de+49 69/ 6301-84055

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 7, 2026