Abstract
BackgroundDepressive disorders are among the most prominent health problems in youth. Even with the best available pharmacological and non-pharmacological treatments, remission rates are low. Without early treatment, depression in youth is associated with a high risk of symptom progression, chronicity, co-morbidity, and suicidal behavior. Thus, adolescent depression is a prime candidate for innovation in treatment. In depressive adults, meta-analytic evidence has proven that bright light therapy (BLT) is a potent low-threshold intervention, promising due to easy application, low side effects, and optimized compliance. In adolescents, studies with small samples show promising effects. This randomized controlled trial will examine the effectiveness of BLT in youth inpatients.Methods/designIn this randomized, controlled, double-blind multicenter parallel group trial, morning BLT is applied for four weeks in addition to treatment as usual (TAU) for depressed youth inpatients (daily morning exposure to bright light via light-emitting glasses, 10,000 lx, for 30 min) and will be compared to a control condition (placebo light treatment, red light, identical light glasses). The primary objective is to assess whether BLT reduces symptoms of depression in youth with greater effect compared to placebo light therapy. Secondary objectives are to examine the impact of BLT on responder status, application of antidepressant medication, and further depression-related symptoms (sleep, activity, quality of life, satisfaction with health, general psychopathology, alertness, and circadian function). N = 224 patients will be recruited in a naturalistic inpatient setting. A follow-up will be carried out after three and six months.DiscussionThe study aims to discuss and evaluate BLT as an additive method supporting standardized clinical procedures dealing with severe to moderate depressive symptoms in youth.Trial registrationGerman Clinical Trials Register, DRKS00013188. Registered on November 30, 2017.
Highlights
DiscussionThe study aims to discuss and evaluate bright light therapy (BLT) as an additive method supporting standardized clinical procedures dealing with severe to moderate depressive symptoms in youth
Depressive disorders are among the most prominent health problems in youth
– examine whether bright light therapy (BLT) in addition to multimodal treatment as usual (TAU) reduces symptoms of depression in youth inpatients with greater effect compared to placebo light therapy plus TAU;
Summary
We presented the background, design, measurements, and statistical procedures of our randomized, controlled, double-blind multicenter parallel group trial of BLT in a naturalistic inpatient setting. We discussed the medical problems regarding treatment and remission rates in adolescents meeting the criteria of depression and constituted the need to close the gap of evidence of BLT in youth therapy by prolonged (four weeks) intervention time and minimized bias problems due to our randomized, double-blind design. There are several limitations the study will have to deal with, e.g. the exclusion of the weekends during intervention periods or lack of evidence for actual wearing time of the glasses because of the naturalistic setting. Since previous studies investigating the effect of BLT in depressed adolescents suffer from small sample sizes, the results of this projected trial will be of great importance.
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