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Terapia de luz para la depresión en pacientes ambulatorios adolescentes

14 de septiembre de 2026 actualizado por: John Parkhurst, Ann & Robert H Lurie Children's Hospital of Chicago

Terapia de luz para la depresión en pacientes ambulatorios adolescentes: un ensayo clínico introductorio con 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

9

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Rachel Ballard

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Depression Severity
Periodo de tiempo: 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
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Anxiety With BLT
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de diciembre de 2021

Finalización primaria (Actual)

8 de noviembre de 2022

Finalización del estudio (Actual)

8 de noviembre de 2022

Fechas de registro del estudio

Enviado por primera vez

27 de marzo de 2023

Primero enviado que cumplió con los criterios de control de calidad

8 de abril de 2023

Publicado por primera vez (Actual)

21 de abril de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2021-4706

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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