Depression in adolescents: A double-blind randomised controlled trial of Bright Light Therapy in a naturalistic inpatient setting.

Depression in adolescents: A double-blind randomised controlled trial of Bright Light Therapy in a naturalistic inpatient setting. - DeLight

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013188

Enrollment

224

Registered

2017-11-30

Start date

2018-03-26

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

F32.1 F32.2 F33.1 F33.2 F92.0

Interventions

Group 1: Morning bright light therapy, light glasses, 10.000 Lux, 4 weeks, 30 minutes/day Group 2: Morning placebo light therapy, light glasses, red light, 4 weeks, 30 minutes/day

Eligibility

Sex/Gender

All

Age

12 Years to 18 Years

Inclusion criteria

Inclusion criteria: Moderate to severe depression (ICD-10 / Beck Depression Inventory II, BDI-II), inpatients, 12-18 years of age, written informed consent/assent.

Exclusion criteria

Exclusion criteria: suicidality, pregnancy or lactation, treatment with betablocker or neuroleptics, bipolar 1 disorder, schizophrenia, diseases of the Retina, IQ<70, insufficient knowledge of German language of the patient or his/her parents

Design outcomes

Primary

Measure	Time frame
Self-reported depressive symptoms after two and four weeks of treamtent-onset (BDI-II)	—

Secondary

Measure	Time frame
- changes in depressive symptoms after three (T3) and six (T4) months with BDI-II - Clinical Global Impression of improvements with CGI-Improvement after the Intervention (T2) and after three (T3) and six (T4) months - improvement and number of treatment responders defined as CGI-I=2 and BDI=28 after the Intervention (T2) - Clinical Impression of changes in depressive symptoms; Children`s Depression Rating Scale-Revised (CDRS-R; Keller et al., 2011; Plener et al., 2012): before (T1) and after (T2) the Intervention and after three (T3) and six (T4) months - Antidepressant Medication Status: Changes in the treatment regime (initiation/cessation/dose-adjustment of antidepressants) will be assessed weekly from baseline until the end of the treatment - Sleep behavior and - Quality (measured with "Schlaffragebogen"; SF-BR; Görtelmeyer et al., 2001), Changes in well-being (KIDSCREEN-10), Physical activity (Domain Resilience of CHIP-AE), General psychopathology (Strengths and Difficulties Questionnaire; SDQ): before (T1) and after (T2) the intervention and after three (T3) and six (T4) months - Changes in sleep and activity will be objectively measured with actigraphy before (T1) and after (T2) the intervention - Changes in level of alertness will be assessed via the subtest “Alertness” of the Testbattery for Attentional Performance (TAP, Zimmermann & Fimm 2002): before (T1) after after (T2) the intervention - Changes in Melatonin and Cortisol will be measured with saliva samples: 5 samples per Patient (T1, T2) - Adverse Events will be measured directly after the intervention (T2) and three (T3) and six (T4) months after the Intervention (Follow-up) Expected and measured moderating variables: -The chronotype (Horne-Ostberg-Morningness-Eveningness-Questionnaire – MEQ – deutsche Version, D-MEQ): before (T1) and after (T2) the intervention and after three (T3) and six (T4) months - the Impact of seasonal Patterns (Seasonal Pattern Assessment Questionaire	—

Measure

Time frame

- changes in depressive symptoms after three (T3) and six (T4) months with BDI-II - Clinical Global Impression of improvements with CGI-Improvement after the Intervention (T2) and after three (T3) and six (T4) months - improvement and number of treatment responders defined as CGI-I=2 and BDI=28 after the Intervention (T2) - Clinical Impression of changes in depressive symptoms; Children`s Depression Rating Scale-Revised (CDRS-R; Keller et al., 2011; Plener et al., 2012): before (T1) and after (T2) the Intervention and after three (T3) and six (T4) months - Antidepressant Medication Status: Changes in the treatment regime (initiation/cessation/dose-adjustment of antidepressants) will be assessed weekly from baseline until the end of the treatment - Sleep behavior and - Quality (measured with "Schlaffragebogen"; SF-BR; Görtelmeyer et al., 2001), Changes in well-being (KIDSCREEN-10), Physical activity (Domain Resilience of CHIP-AE), General psychopathology (Strengths and Difficulties Questionnaire; SDQ): before (T1) and after (T2) the intervention and after three (T3) and six (T4) months - Changes in sleep and activity will be objectively measured with actigraphy before (T1) and after (T2) the intervention - Changes in level of alertness will be assessed via the subtest “Alertness” of the Testbattery for Attentional Performance (TAP, Zimmermann & Fimm 2002): before (T1) after after (T2) the intervention - Changes in Melatonin and Cortisol will be measured with saliva samples: 5 samples per Patient (T1, T2) - Adverse Events will be measured directly after the intervention (T2) and three (T3) and six (T4) months after the Intervention (Follow-up) Expected and measured moderating variables: -The chronotype (Horne-Ostberg-Morningness-Eveningness-Questionnaire – MEQ – deutsche Version, D-MEQ): before (T1) and after (T2) the intervention and after three (T3) and six (T4) months - the Impact of seasonal Patterns (Seasonal Pattern Assessment Questionaire

—

Countries

Germany

Contacts

Public ContactMaren Terwege

LWL-Universitätsklinik für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik

maren.terwege@lwl.org02381-893-5021

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026