Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
Condition: Sleep Phase Rhythm Disturbance; Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Previous data suggest some depressed patients act as if their internal biological clock is
      out of sync with the outside world and re-aligning their clock with the timing of sunlight
      lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may
      produce remission during the first week of treatment while causing minimal problems. This
      study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for
      inducing sleep phase advance. Which chronotherapy condition a participant will receive will
      be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to
      determination of which protocol a patient will follow, each patient will declare their
      desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific
      times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned
      sleep times will differ between groups using different strategies to shift the timing of
      their sleep from their ideal sleep time as determined by their Morningness-Eveningness
      Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily
      by telephone for the first week following randomization, and then weekly for an additional
      five weeks. Whenever possible, weekly visits will be in person, although telephone visits
      will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an
      Independent Evaluator blind to treatment assignment (as well as the nature of the treatment
      and if it has occurred or not). After the six week post-randomization evaluation, all
      participants will be offered six months of continued treatment and be rated monthly.
      Treatment during this six month period may consist of Chronotherapy or conventional
      antidepressants as the patient and doctor determine. Standard ratings of depression, over-all
      illness and functioning will be obtained. Change in the symptom measures will determine
      treatment efficacy. Analysis of saliva melatonin levels, sleep logs and activity monitor data
      will measure the timing of the biological clock and whether it has been shifted by the
      treatment. Measures of functioning will determine whether functioning improves coincident
      with, independent of, or subsequent to mood improvement.
    

Detailed description: 
      This study will investigate the utility of regimented sleep and lights in depressed subjects.
      Based on current timing of sleep, desired sleep time and responses to the
      Morningness-Eveningness Questionnaire, each subject who remains significantly depressed at
      their randomization (usually 2nd) visit, will be randomly assigned to one of two regimented
      sleep and light use protocols. On the night beginning their assigned regimented protocol,
      each subject will wear amber goggles for five hours and collect half hourly saliva samples
      for four hours. Each morning they will sit in front of a light box wearing goggles. During
      the first week following the start of the regimented protocol, they will complete self-report
      forms and have a telephone interview to document their depressive symptoms. They will have
      weekly in person interviews for six weeks and evaluations by an independent evaluator in
      person or by telephone at randomization, 2 and 6 weeks. Prior to their Week 2 Visit, they
      will wear the goggles for the four hours prior to their assigned bedtime and for the three
      hours prior to their assigned bedtime, they will collect half hourly saliva samples. At their
      Week 6 interview, they and their doctor will determine whether they have improved
      sufficiently or not. Their doctor will discuss with them whether it makes sense for them to
      continue the same regimented sleep/light schedule, make a change to it or switch to or add
      additional treatment, such as antidepressant medication. They will then be followed with
      study ratings monthly for six months, during which treatment is unrestricted; that is, the
      doctor and patient can determine what the treatment during this time will be. Following the
      six months follow-up, a referral will be made if appropriate.

      All saliva samples will be analyzed for melatonin concentration.
    

Intervention name(s): Morning Light Therapy; Assigned Sleep Times; Goggles
Intervention type(s): Behavioral; Behavioral; Device
Intervention description(s): 10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.; Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.; Subjects will wear goggles during saliva collection and Bright Light Therapy
Other intervention name(s): Light Therapy; Sleep Phase Advance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronotherapy; Light Therapy