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

NCT ID: NCT02503124

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2020-03-15

Brief Summary

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

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronobiological intervention

Single night's wake therapy followed by bright light therapy for a week as add-on treatment to treatment as usual.

Group Type EXPERIMENTAL

Single night's wake therapy

Intervention Type BEHAVIORAL

Eligible patients are assisted in maintaining total sleep deprivation during one night

Bright light

Intervention Type DEVICE

Bright light according to patients´ own circadian rhythm each morning for a week.

Treatment as usual - inpatient care

Intervention Type OTHER

All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.

Treatment as usual - medicine

Intervention Type DRUG

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.

Control

Treatment as usual including a private educational meeting in sleep hygiene.

Group Type ACTIVE_COMPARATOR

Treatment as usual - inpatient care

Intervention Type OTHER

All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.

Informative meeting

Intervention Type OTHER

A short sleep hygiene consultation.

Treatment as usual - medicine

Intervention Type DRUG

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.

Interventions

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Single night's wake therapy

Eligible patients are assisted in maintaining total sleep deprivation during one night

Intervention Type BEHAVIORAL

Bright light

Bright light according to patients´ own circadian rhythm each morning for a week.

Intervention Type DEVICE

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.

Intervention Type OTHER

Informative meeting

A short sleep hygiene consultation.

Intervention Type OTHER

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.

Intervention Type DRUG

Other Intervention Names

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Sleep deprivation

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Steinn Steingrimsson

MD, PhD, resident in psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steinn Steingrimsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CB001

Identifier Type: -

Identifier Source: org_study_id

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