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

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02750631

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unipolar Depression	Other: Triple Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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).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).

Masking:

None (Open Label)

Masking Description:

All patients and staff know what the treatment is.

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Triple Therapy Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance	Other: Triple Therapy The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance Other Names: Chronotherapeutics

Arm

Intervention/Treatment

Experimental: Triple Therapy

Combined Wake Therapy (one night of missed sleep), early morning bright light and sleep phase advance

Other: Triple Therapy

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

Other Names:

Chronotherapeutics

Outcome Measures

Primary Outcome Measures

17-item Hamilton Rating Scale for Depression [1 week]
The Hamilton Rating Scale for Depression is a standard clinician scored rating of depressed mood and the symptoms commonly associated with clinical depression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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