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

New York State Psychiatric Institute

Status: Completed

Conditions: Unipolar Depression

Treatments: Other: Triple Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02750631

6938

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Triple Therapy

Experimental group

Description:

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

Treatment:

Other: Triple Therapy