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Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression

Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02750631
Acronym
WakeTherapy
Enrollment
30
Registered
2016-04-25
Start date
2014-04-30
Completion date
2017-07-31
Last updated
2017-08-29

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

Conditions

Unipolar Depression

Keywords

depression, melatonin, light therapy, Wake Therapy, chronobiology

Brief summary

Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times ending at their desired sleep time. Beginning the morning following their Wake Night, patients sit in front of a bright light, continuing morning bright light and specified sleep time for six weeks with weekly visits measuring depressive symptoms.

Detailed description

Nonpsychotic, nonbipolar, physically healthy depressed patients keep sleep, mood and energy logs for a week, complete the Morningness-Eveningness Questionnaire (measuring morningness and eveningness) and determine the time patients want to sleep. Patients then miss a night of sleep and subsequently are allowed later and later sleep times until patients are sleeping at their desired time. Beginning the morning following their Wake Night, patients sit in front of bright lights at their intended wake-up time for the next six weeks and once their allowed sleep time is their intended sleep time, patients also continue to only be allowed to sleep between those times (e.g., 11 p.m. to 7 a.m.). Daily sleep, energy and mood logs and activity monitoring are maintained throughout with weekly clinician ratings. In additional, daily telephone check ins occur during the first week following the Wake Night both to be sure the patient is following the protocol and to obtain symptom ratings. Saliva to be measured for melatonin is collected prior to and following sleep adjustment.

Interventions

The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance

Sponsors

New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

All patients and staff know what the treatment is.

Intervention model description

All patients receive Chronotherapy, which consists of a night of no sleep (Wake Therapy) followed by bright lights at their desired sleep time and two nights of Sleep Phase Advance (i.e., sleeping 6 hours earlier than desired for 1 night and 3 hours earlier for the next night, then desired sleep time).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* major depressive disorder or persistent depressive disorder or unspecified depressive disorder * physically healthy * patients over age 60 need primary care physician's approval, electrocardiogram and Mini Mental Status Examination

Exclusion criteria

* medically unstable condition * bipolar disorder * current (past six months) substance use disorder * significant suicide risk * need for hospitalization * history of psychosis

Design outcomes

Primary

MeasureTime frameDescription
17-item Hamilton Rating Scale for Depression1 weekThe Hamilton Rating Scale for Depression is a standard clinician scored rating of depressed mood and the symptoms commonly associated with clinical depression

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026