Pilot Randomized-controlled phase-IIa trial on the prevention of comorbid Depression and Obesity in Attention-deficit / Hyperactivity disorder <br>

Phase 2

Completed

Conditions: ADHD
attention deficit hyperactivity disorder
10009841

Registration Number: NL-OMON45280

Lead Sponsor: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt, Goethe Universität

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 55

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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