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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2020-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Attention-Deficit / Hyperactivity Disorder Depression Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Observer-blinded assessment of the primary outcome measure

Study Groups

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Bright light therapy

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.

Group Type EXPERIMENTAL

Bright light therapy

Intervention Type 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.

Physical exercise

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.

Group Type EXPERIMENTAL

Physical exercise

Intervention Type 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.

Treatment as usual

Stable treatment as usual comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of bright light therapy or exercise).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bright light therapy

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.

Intervention Type BEHAVIORAL

Physical exercise

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No