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

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

Official Title
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Wake and Bright Light Therapy for Depression Among Admitted Patients

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Single night's wake therapy
* Device: Bright light
* Other: Treatment as usual - inpatient care
* Other: Informative meeting
* Drug: Treatment as usual - medicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronobiological intervention<br>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<br>* Eligible patients are assisted in maintaining total sleep deprivation during one night<br>* Other names: Sleep deprivation;Device: Bright light<br>* Bright light according to patients´ own circadian rhythm each morning for a week.<br>Other: Treatment as usual - inpatient care<br>* All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.<br>Drug: Treatment as usual - medicine<br>* 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.<br>|
| Active Comparator: Control<br>Treatment as usual including a private educational meeting in sleep hygiene. | Other: Treatment as usual - inpatient care<br>* All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.<br>Other: Informative meeting<br>* A short sleep hygiene consultation.<br>Drug: Treatment as usual - medicine<br>* 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.<br>|

What is the study measuring?
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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 |