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

NCT02503124 | Terminated

• 1 other identifier: CB001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• MADRS-S score reduction of 50%

  Montgomery Asberg Depression Rating Scale

  One week

Secondary Outcomes (10)

• MADRS-S score at discharge

  Participants will be followed at discharge, an expected average of 2-3 weeks

• MADRS-S score at follow-up

  10-14 weeks

• ISI score score at discharge

  Participants will be followed at discharge, an expected average of 2-3 weeks

• ISI score score at follow-up

  10-14 weeks

• ISI score reduction of 50%

  One week

Study Arms (2)

Chronobiological intervention

EXPERIMENTAL

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; Device: Bright light; Other: Treatment as usual - inpatient care; Drug: Treatment as usual - medicine

Control

ACTIVE COMPARATOR

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

Other: Treatment as usual - inpatient care; Other: Informative meeting; Drug: Treatment as usual - medicine

Interventions

Single night's wake therapy BEHAVIORAL

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

Also known as: Sleep deprivation

Chronobiological intervention

Bright light DEVICE

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

Chronobiological intervention

Treatment as usual - inpatient care OTHER

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

Chronobiological intervention; Control

Informative meeting OTHER

A short sleep hygiene consultation.

Control

Treatment as usual - medicine 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.

Chronobiological intervention; Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Steinn Steingrimsson, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, resident in psychiatry

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

SE (1)