Light Therapy for Depression in Adolescent Outpatients
Condition: Depression; Adolescent - Emotional Problem
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): light box (Carex DayLight Classic Model)
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: placebo lead-in open trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: light therapy