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

Not Applicable

Terminated

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

• Registration Number: NCT02503124
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronobiological intervention	Bright light	Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.
Chronobiological intervention	Single night's wake therapy	Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.
Control	Treatment as usual - inpatient care	Treatment as usual including a private educational meeting in sleep hygiene.
Control	Treatment as usual - medicine	Treatment as usual including a private educational meeting in sleep hygiene.
Chronobiological intervention	Treatment as usual - inpatient care	Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.
Chronobiological intervention	Treatment as usual - medicine	Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.
Control	Informative meeting	Treatment as usual including a private educational meeting in sleep hygiene.

Primary Outcome Measures

Name	Time	Method
MADRS-S score reduction of 50%	One week	Montgomery Asberg Depression Rating Scale

Secondary Outcome Measures

Name	Time	Method
MADRS-S score at discharge	Participants will be followed at discharge, an expected average of 2-3 weeks	Montgomery Asberg Depression Rating Scale
MADRS-S score at follow-up	10-14 weeks	Montgomery Asberg Depression Rating Scale
ISI score score at discharge	Participants will be followed at discharge, an expected average of 2-3 weeks	Insomnia Severity Index - Self administered scale of sleep quality
ISI score score at follow-up	10-14 weeks	Insomnia Severity Index - Self administered scale of sleep quality
ISI score reduction of 50%	One week	Insomnia Severity Index - Self administered scale of sleep quality
Length of stay	The number of days between admission and discharge	Patients will be followed up 10-14 weeks after discharge and the total number of days in inpatient services calculated.
Re-admission	10-14 weeks
CGI score	10-14 weeks	Clinical global impression
Medication use	10-14 weeks	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.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland, Sweden