Back to resultsEffect of a Single Nights' Wake Followed by Bright Light Therapy for Severe Depression
Primary Purpose
Depression
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Single night's wake therapy
Bright light
Treatment as usual - inpatient care
Informative meeting
Treatment as usual - medicine
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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
Sites / Locations
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chronobiological intervention
Control
Arm Description
Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.
Treatment as usual including a private educational meeting in sleep hygiene.
Outcomes
Primary Outcome Measures
MADRS-S score reduction of 50%
Montgomery Asberg Depression Rating Scale
Secondary Outcome Measures
MADRS-S score at discharge
Montgomery Asberg Depression Rating Scale
MADRS-S score at follow-up
Montgomery Asberg Depression Rating Scale
ISI score score at discharge
Insomnia Severity Index - Self administered scale of sleep quality
ISI score score at follow-up
Insomnia Severity Index - Self administered scale of sleep quality
ISI score reduction of 50%
Insomnia Severity Index - Self administered scale of sleep quality
Length of stay
Patients will be followed up 10-14 weeks after discharge and the total number of days in inpatient services calculated.
Re-admission
CGI score
Clinical global impression
CGI score
Clinical global impression
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.
Full Information
NCT ID
NCT02503124
First Posted
July 10, 2015
Last Updated
March 30, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02503124
Brief Title
Effect of a Single Nights' Wake Followed by Bright Light Therapy for Severe Depression
Official Title
Wake and Bright Light Therapy for Depression Among Admitted Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 and re-organisation at the hospital
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized controlled trial comparing wake therapy (single night) followed by bright light therapy to treatment as usual.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chronobiological intervention
Arm Type
Experimental
Arm Description
Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment as usual including a private educational meeting in sleep hygiene.
Intervention Type
Behavioral
Intervention Name(s)
Single night's wake therapy
Other Intervention Name(s)
Sleep deprivation
Intervention Description
Eligible patients are assisted in maintaining total sleep deprivation during one night
Intervention Type
Device
Intervention Name(s)
Bright light
Intervention Description
Bright light according to patients´ own circadian rhythm each morning for a week.
Intervention Type
Other
Intervention Name(s)
Treatment as usual - inpatient care
Intervention Description
All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.
Intervention Type
Other
Intervention Name(s)
Informative meeting
Intervention Description
A short sleep hygiene consultation.
Intervention Type
Drug
Intervention Name(s)
Treatment as usual - medicine
Intervention Description
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.
Primary Outcome Measure Information:
Title
MADRS-S score reduction of 50%
Description
Montgomery Asberg Depression Rating Scale
Time Frame
One week
Secondary Outcome Measure Information:
Title
MADRS-S score at discharge
Description
Montgomery Asberg Depression Rating Scale
Time Frame
Participants will be followed at discharge, an expected average of 2-3 weeks
Title
MADRS-S score at follow-up
Description
Montgomery Asberg Depression Rating Scale
Time Frame
10-14 weeks
Title
ISI score score at discharge
Description
Insomnia Severity Index - Self administered scale of sleep quality
Time Frame
Participants will be followed at discharge, an expected average of 2-3 weeks
Title
ISI score score at follow-up
Description
Insomnia Severity Index - Self administered scale of sleep quality
Time Frame
10-14 weeks
Title
ISI score reduction of 50%
Description
Insomnia Severity Index - Self administered scale of sleep quality
Time Frame
One week
Title
Length of stay
Description
Patients will be followed up 10-14 weeks after discharge and the total number of days in inpatient services calculated.
Time Frame
The number of days between admission and discharge
Title
Re-admission
Time Frame
10-14 weeks
Title
CGI score
Description
Clinical global impression
Time Frame
One week
Title
CGI score
Description
Clinical global impression
Time Frame
10-14 weeks
Title
Medication use
Description
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.
Time Frame
10-14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steinn Steingrimsson, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of a Single Nights' Wake Followed by Bright Light Therapy for Severe Depression
We'll reach out to this number within 24 hrs