Wake and Light Therapy to In-patients With Major Depression: Efficacy, Predictors and Patient Experiences

NCT02047968 | Completed DMC

• 1 other identifier: VT12
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to examine whether a combination of wake therapy, light therapy and sleep time stabilization as a supplement to standard treatment can reduce depressive symptoms in patients admitted at two psychiatric wards at Aarhus University Hospital, Risskov. Seventy-four patients will be randomized either to this intervention or to a control group receiving treatment as usual. Furthermore, it will be examined whether the duration of admission can be reduced in the intervention group. Finally, the aim is to identify predictors of good effect of the intervention.

Conditions

Major Depression

Keywords

Wake therapy; Sleep deprivation; Light therapy; Bipolar depression; Sleep-wake cycle; Major depression; Depression; Depressive Disorder; Major Behavioural Symptoms; Mood Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Affective Disorders

Outcome Measures

Primary Outcomes (1)

• Response

  Response is defined as a 50 % reduction or more compared to the baseline score in HAM-D 17.

  Week two

Secondary Outcomes (4)

• Remission

  Week two

• Length of admission

  Week nine

• Percentage of patients with response

  week nine

• Percentage of patients with remission

  week nine

Study Arms (2)

wake therapy, light therapy and sleep time stabilisation

EXPERIMENTAL

Wake therapy/sleep deprivation: Patients are awake for 36 hours three times in one week with a normal night of sleep between. Light therapy for 30 minutes daily in the entire study period. Sleep time stabilisation which involves psychoeducation regarding sleep hygiene and keeping the day-night cycle constant.

Behavioral: wake therapy

treatment as usual

NO INTERVENTION

Interventions

wake therapy BEHAVIORAL

Also known as: light therapy, sleep time stabilisation

wake therapy, light therapy and sleep time stabilisation

Eligibility Criteria

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

You may qualify if:

• A diagnosis of major depression according to DSM-IV
• A score on the Hamilton Depression Scale, 17 items version of at least 18
• Patient with major depression as part of a bipolar disorder should be in adequate mood stabilising therapy at entry to the study
• Age of 18 to 65
• Speak and understand Danish

You may not qualify if:

• Severe suicidal ideation (a score of 3 or above on the Hamilton Depression Scale, 17-items version)
• Anxiety psychic or somatic (a score of 3 or above on the Hamilton Depression Scale, 17-items version)
• personality disorder according to DSM-IV
• Drug or alcohol abuse
• Psychotic disorder
• Pregnancy
• Glaucoma
• Epilepsy

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Mette Kragh

Risskov, Central Jutland, 8240, Denmark

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Deprivation; Bipolar Disorder; Depression; Depressive Disorder; Mood Disorders; Mental Disorders; Dyssomnias; Sleep Wake Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mette Kragh, RN, MSc, PhDstudent

  Department of Affective Disorders Q

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 29, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

DK (1)