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 - PROUD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45280

Enrollment

Registered

2017-10-10

Start date

2018-04-10

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

ADHD

Interventions

In the planned pilot randomized-controlled Phase-IIa study, we will establish feasibility and effect sizes of two interventions, Bright Light Therapy (BLT) and Aerobic exercise intervention (AEI), i

ADHD

comorbidity

Intervention

Eligibility

Age

12 Years to 64 Years

Inclusion criteria

Inclusion criteria: - All subjects must meet DSM-5 criteria for a lifetime history of childhood onset ADHD (DSM-5 314.00, 314.01) as well as current ADHD criteria - Age: 14-30 years old. - Stable TAU comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of BLT or AEI).

Exclusion criteria

Exclusion criteria: - Any severe medical or neurological condition interfering with interventions. - Any severe medical or neurological condition not allowing BLT or AEI. - Use of antipsychotic or anti-epileptic medication, photos-sensitising medication (e.g., Lithium, St. John's Wort) - Substance use disorder (DSM-5) or dependency (DSM-5) - History of epilepsy - Acute suicidal ideation - Pregnancy

Design outcomes

Primary

Measure	Time frame
To assess the prevention of depressive symptoms by 10-weeks BLT and 10-weeks AEI vs. TAU, and to establish feasibility and effect sizes of these two kinds of interventions in combination with a m-Health app based reinforcement.Descriptive analyses of treatment response group; exploratory analysis of intervention effects in subgroups and of potential prognostic factors.	—

Secondary

Measure	Time frame
To assess the prevention of obesity and the improvement of general health and ADHD symptoms by 10-weeks BLT and 10-weeks AEI interventions vs. TAU in combination with a m-Health app based reinforcement. Descriptive analyses of treatment response group; exploratory analysis of intervention effects in subgroups and of potential prognostic factors.	—

Countries

Germany, Spain, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)