Primary objective: 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 in…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The risk for comorbid obesity and major depressive disorder is increased in
adolescents and adults with attention-deficit / hyperactivity disorder (ADHD)
and adolescent ADHD predicts adult obesity and major depressive disorder.
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. In addition, it has been shown that reinforcement-based exercise
interventions using a mobile health (m-Health) approach resulted in improved
effects on weight-loss in obesity. To date, it is not known whether BLT and
exercise interventions in combination with m-Health based reinforcement prevent
and/or reduce depression and obesity in adolescents and young adults with ADHD.
Study objective
Primary objective: 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 in adolescents and young adults aged 14 to 30 years old with
ADHD.
Secondary objectives: 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 in
adolescents and young adults aged 14 to 30 years old with ADHD. Descriptive
analyses of treatment response group; exploratory analysis of intervention
effects in subgroups and of potential prognostic factors.
Study design
The study is a three arm (two treatment groups and one control group) phase-IIa
pilot randomized, observer-blinded, controlled, prospective, multi-centre study
with five measurement points.
Intervention
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), in combination with m-Health based
monitoring and reinforcement in adolescents and young adults with ADHD as
add-on treatment to TAU compared to TAU alone.
BLT: Mobile therapeutic light (10.000 LUX, white light without UV light), daily
(except Sunday) for 30 min for 10 weeks in total provided by a BLT device (
Philips EnergyLight HF 3419). The exact time of day of implementation (either
during the morning or the evening) is determined by the type of Chronoprofile
(Morning- or Evening type) of each study participant determined by the MEQ.
AEI: The physical exercise intervention consists in training three days a week
during 10 weeks. Participants will 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.
Study burden and risks
Generally, both, BLT and AEI, are considered as safe interventions with no
specific, relevant risk conferred to the trial participants. The BLT device
implemented in this study (Chronolux Medic-4) uses UV and IR filtered
therapeutic light (10.000 LUX) and is thus safe for eyes and skin. If side
effects occur (e.g. nausea, headache, eyestrain), they are usually mild and
short lasting. In rare circumstances, BLT can trigger a manic episode in
bipolar disorder, which therefore is an exclusion criterion. Regarding the AEI
arm of the intervention, it should be said that the risks associated with
exercise are directly related to the *dose* of exercise and top athletes are at
a high risk of suffering different type of injuries. However, in this study,
the exercise administered will be recreational and only small injuries (e.g.
ankle sprain) might occur with a similar probability than when being at the
school recess (in the case of adolescent participants) or in any daily
activity. All participants will undergo a medical examination to exclude any
severe medical or neurological condition not allowing BLT (i.e. an eye
condition that makes your eyes vulnerable to light damage or other diseases
with effects on the retina such as Diabetes mellitus) or AEI (i.e. heart
disease, high blood pressure, injuries).
Deutschordenstr. 50
Frankfurt 60528
DE
Deutschordenstr. 50
Frankfurt 60528
DE
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60194.091.17 |