Effect of a Single Nights' Wake Followed by Bright Light Therapy for Severe Depression

Wake and Bright Light Therapy for Depression Among Admitted Patients

A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual.

Study Overview

• Status: Terminated
• Conditions: Depression
• Intervention / Treatment: Behavioral: Single night's wake therapy; Device: Bright light; Other: Treatment as usual - inpatient care; Drug: Treatment as usual - medicine; Other: Informative meeting

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Depressive episode requiring admission to a psychiatric hospital (including unipolar and bipolar depression).

Exclusion Criteria:

• Psychotic symptoms/agitation
• Compulsory admission
• Confusion
• Active substance use disorder
• Eye disease preventing bright light therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chronobiological intervention; Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.	Behavioral: Single night's wake therapy; Eligible patients are assisted in maintaining total sleep deprivation during one night; Other Names: Sleep deprivation; Device: Bright light; Bright light according to patients´ own circadian rhythm each morning for a week.; Other: Treatment as usual - inpatient care; All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.; Drug: Treatment as usual - medicine; Since all patients are admitted due to a severe mental illness, they will receive medication according to indication. Most patients have already tried more than one antidepressant at the time of admission. In cases of severe anxiety, anxiolytics are prescribed but this is kept to a minimum.
Active Comparator: Control; Treatment as usual including a private educational meeting in sleep hygiene.	Other: Treatment as usual - inpatient care; All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.; Drug: Treatment as usual - medicine; Since all patients are admitted due to a severe mental illness, they will receive medication according to indication. Most patients have already tried more than one antidepressant at the time of admission. In cases of severe anxiety, anxiolytics are prescribed but this is kept to a minimum.; Other: Informative meeting; A short sleep hygiene consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS-S score reduction of 50%	Montgomery Asberg Depression Rating Scale	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS-S score at discharge	Montgomery Asberg Depression Rating Scale	Participants will be followed at discharge, an expected average of 2-3 weeks
MADRS-S score at follow-up	Montgomery Asberg Depression Rating Scale	10-14 weeks
ISI score score at discharge	Insomnia Severity Index - Self administered scale of sleep quality	Participants will be followed at discharge, an expected average of 2-3 weeks
ISI score score at follow-up	Insomnia Severity Index - Self administered scale of sleep quality	10-14 weeks
ISI score reduction of 50%	Insomnia Severity Index - Self administered scale of sleep quality	One week
Length of stay	Patients will be followed up 10-14 weeks after discharge and the total number of days in inpatient services calculated.	The number of days between admission and discharge
Re-admission		10-14 weeks
CGI score	Clinical global impression	One week
CGI score	Clinical global impression	10-14 weeks
Medication use	The use of antidepressants, anxiolytics or other psychiatric medication will be registered at follow-up. The number of patients using more than one medication and the dosage will be compared.	10-14 weeks

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Steinn Steingrimsson, MD, PhD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: CB001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED