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Luminothérapie pour la dépression chez les adolescents ambulatoires

14 septembre 2026 mis à jour par: John Parkhurst, Ann & Robert H Lurie Children's Hospital of Chicago

Thérapie par la lumière pour la dépression chez les adolescents ambulatoires : un essai clinique préliminaire avec placebo

The goal of this placebo lead-in clinical trial was to test bright light therapy (BLT) in adolescents with depression. The main question[s] it aimed to answer were:

  1. characterize and define facilitators/barriers to treatment with BLT in adolescents);
  2. evaluate the acceptability and feasibility of outpatient BLT in a dose titration protocol;
  3. establish an effective, safe and tolerable light dose.

Aperçu de l'étude

Description détaillée

This outpatient study was performed at Ann & Robert H. Lurie Children's Hospital of Chicago. The Institutional Review Boards (IRB) of Lurie Children's Hospital and Northwestern University, Feinberg School of Medicine approved the protocol. Participants were recruited through partnering community pediatric practices (namely Lake Forest Pediatrics). Primary care pediatricians referred potential participants with depression and elevated scores on youth screening measures, Patient Health Questionnaire-9 (≥ 9) or PHQ-2 (≥ 3), without endorsed suicidality.

Light Therapy Protocol with Placebo Lead-in. Eligible participants were provided a light box and an actigraphy wrist watch and given instructions on the use of each. The active light box (Carex DayLight Classic Model) is a white fluorescent 4000 Kelvin unit that emits 10,000 lux and measures 33cm x 40cm. The placebo box emits 50 lux dim red light and appears identical to the active unit. Dim red light was selected because the illumination is a plausible placebo in clinical trials of BLT for depressive disorders and produces negligible effects on circadian rhythms and mood responses. Subjects were instructed to position themselves 30-36 cm from the box with their faces fully exposed to the light. The actigraphy device is a Philips Spectrum Plus actigraphy watch which collects activity level and sleep information along with multiple light measurements and wearer adherence. The light therapy dosing protocol was planned as follows: Weeks 0-2, 50 lux dim red light (DRL) x 30 minutes/day; weeks 3-4, 10,000 lux x 15 minutes/day; weeks 5-6, 10,000 lux x 30 minutes/day; weeks 6-8, 10,000 lux x 45 minutes/day. At week 2, the study coordinator (KJ) dispensed the 10,000 lux BLT unit (and picked up the dim red light box) and the actigraph watch. Participants and their parent/guardian met with 2 study clinicians at the end of each 2-week period. One study clinician (RB or JP), who was blinded to the participant's light box use, conducted a brief interview regarding mood, safety and functioning, and assigned a Clinical Global Impressions Scale-Severity (CGI-S). The other study clinician (DKS) subsequently met with the participant to review safety, side effects and response and made recommendations on duration and timing of light box use based on level of improvement and any barriers to use. Thus, some patients did not receive the above dosing schedule. After the 8-week active study period, participants who had symptom remission were given the option to keep the light box and continue use. A treatment summary and ongoing treatment recommendations were provided to all participant's primary care clinicians.

Adherence. The study coordinator made weekly calls/texts to participants to inquire about their daily exposure times and to encourage proper adherence. The constraints imposed upon adolescents by schools (early morning start times by 8:00 AM), bus commutes (pick up by 7:30 AM), after school activities and part-time jobs (landscaping etc.) are considerable. Knowing this and to avoid forcing adolescents to wake earlier than preferred (which can produce detrimental effects on adolescent sleep and mood) to use the study light box, participants agreed to initiate BLT exposure in the morning at awakening in accordance to the dosing protocol. At follow up visits, the non-blind clinician systematically explored whether morning use remained feasible and acceptable. If not, the clinician made informed clinical recommendations and recorded adjustments to the time-of-day of use (midday or afternoon) to ensure participants were able to consistently use the box. This strategy informed investigators and participants of the optimal timing of light exposure, increased adherence and strengthened the reliability of detecting response.

Actigraphic Assessments. Actigraphy using a wrist actigraph with a light sensor (Actiwatch Spectrum, Philips Respironics Healthcare, Bend, OR, USA) was used to measure a number of actigraphic-derived sleep, circadian, activity and light variables during the placebo and active light treatment phases.

Type d'étude

Interventionnel

Inscription (Réel)

9

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Rachel Ballard

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Participants with depression and elevated scores on youth screening measures, Patient Health Questionnaire-9 (PHQ-9 (≥ 9) or PHQ-2 (≥ 3).
  • English-speaking primary caregiver legally able to provide consent and who could contribute weekly mood ratings.

Exclusion Criteria:

  • Current or past diagnoses of bipolar disorder, moderate to severe autism, schizophrenia, or schizoaffective disorder, or intellectual disability; a major medical illness or ocular condition (e.g. glaucoma, retinal disease, macular degeneration) that would interfere with participation in the study; significant and imminent risk to self or to others; concurrent
  • Recent (<4 months) medication or new (< 3 months) psychotherapy treatment for depression
  • Current use of melatonin, beta-blockers, chloroquine, or regular non-steroidal anti-inflammatory agents, or St. John's Wort.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bright light therapy

Eligible participants were provided a light box and an actigraphy wrist-watch and given instructions on the use of each. The light therapy dosing protocol was planned as follows: Weeks 0-2, 50 lux dim red light (DRL) x 15 30 minutes/day; weeks 3-4, 10,000 lux x 15 minutes/day; weeks 5-6, 10,000 lux x 30 minutes/day; weeks 6-8, 10,000 lux x 45 minutes/day. At week 2, the study coordinator dispensed the 10,000 lux BLT unit (and picked up the DRL box) and the actigraphy watch. Participants and their parent/guardian met with 2 study clinicians at the end of each 2-week period. One study clinician, who was blinded to the participant's light box use, conducted a brief interview regarding mood, safety and functioning and side effects. The other study clinician subsequently met with the participant to review safety, side effects and response and made recommendations on duration and timing of light box use based on level of improvement and any barriers to use.

The active light box is a white fluorescent 4000 Kelvin unit that emits 10,000 lux and measures 33cm x 40cm. The placebo box emits 50 lux dim red light and appears identical to the active unit. Subjects were instructed to position themselves 30-36 cm from the box with their faces fully exposed to the light. The actigraphy device is a Phillips Spectrum Plus Actigraphy watch which collects activity level and sleep information along with multiple light measurements and wearer adherence.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Depression Severity
Délai: Baseline to week 2, week 8

Depression severity measured by the following:

Child and Parent Short Mood and Feelings Questionnaire (SMFQ) (Messer et al., 1995). The SMFQ (13 items) has good internal consistency (α = .92) (Eyre et al., 2021). Units of measurement range from (0-26 with, 0 = No severity and symptomology, 26 = extreme severity and symptomology)

Clinician Reported Clinical Global Impression-Improvement and Severity Rating Scales (CGI-S) (Guy, 1976) The CGI-S measures provides a global rating of severity of the participant's anxiety disorder. The ratings were made by an Independent Evaluation on a 1 (not at all ill) to 7 (extremely ill) scale. Scores of 1 or 2 reflect minimal symptoms; scores of 1 or 2 are considered remission status and higher scores (3-7) as not in remission.

Baseline to week 2, week 8
Adherence to BLT in Adolescent Outpatients With Depression
Délai: 8 week study period (measured at Week 2, Week 4, and Week 8)

The participation rate (%) defined as daily use of the light therapy box.

8 week study period (measured at Week 2, Week 4, and Week 8)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Anxiety With BLT
Délai: Baseline to study week 8

Screen for Child Anxiety Related Emotional Disorders (SCARED).(Birmaher et al., 1997) The SCARED is a 41-item child- and parent-measure of child anxiety symptoms that includes a total anxiety scale and subscales of Separation Anxiety (SEP), Generalized Anxiety (GAD), Social Anxiety (SOC), Panic/Somatic symptoms, and School Avoidance. The internal consistency of the SCARED total score was α = .94.(Muris & Steerneman, 2001)

Scale of Child Anxiety Related Disorders scale (score ranges from 0-82, with higher scores indicating worse outcomes).

Baseline to study week 8

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: John T Parkhurst, PhD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 décembre 2021

Achèvement primaire (Réel)

8 novembre 2022

Achèvement de l'étude (Réel)

8 novembre 2022

Dates d'inscription aux études

Première soumission

27 mars 2023

Première soumission répondant aux critères de contrôle qualité

8 avril 2023

Première publication (Réel)

21 avril 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2021-4706

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

The investigators do not plan to share individual participant data with other researchers.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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