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

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047968
• Other study ID #: VT12
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: October 28, 2016
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Description:

Background: About 150,000 Danes will constantly have symptoms of depression, and 20% of those are admitted to a psychiatric hospital at least once. When admitted, the patients are highly tormented and many have suicide thoughts. The treatment of depression in a ward consists of beginning or adjustment of antidepressive medication combined with for instance milieu therapy, psychotherapy and exercise offers. Full effect of medical treatment is only reached after 4-6 weeks, and no quicker effect is documented in the other treatment methods. Therefore, methods are needed which quickly, effectively and without large side effects can reduce the symptoms. Wake therapy is a treatment method which has appeared to stop or reduce depressive symptoms within hours, and several studies have demonstrated that up to 66% of the patients responded to wake therapy. The method consists in the patients staying awake for one night and the following day, in all 36 hours, which is followed by one night of sleep. Light therapy and stabilisation of circadian rhythm have been shown to maintain the effect of wake therapy.

Objective: To examine the efficacy of using wake and light therapy as a supplement to standard treatment of hospitalised patients with depression and to identify the characteristics of patients who accept and respond well to the treatment.

Methods: The project is carried out as a randomised controlled study and will include 74 patients with bipolar or unipolar depression. The patients are randomised to standard treatment or to the intervention, which besides standard treatment will consist of three times wake therapy in one week and 30 minutes daily light treatment in the entire nine week study period as well as ongoing guidance in good sleep hygiene. Raters for the Hamilton rating will be blinded to the treatment assignment.

Outcome: Primary outcome criteria will be the response rate in week two. Response is defined as a 50 % reduction or more compared to the baseline score in HAM-D 17. Secondary outcomes will be the remission rate in week two, the length of admission and the percentage of patients with response and remission in week nine.

Variables and Assessment: Severity of depression will be assessed by using the interview-based Hamilton Depression Rating scale, both the 17 item and the 6 item version. For patient-reported outcome measures the Major Depression Inventory (MDI) and the World Health Organisation (WHO)-5 wellbeing Index (WHO-5) will be used. Social and Occupational Functional Assessment Scale (GAF) and Bech-Rafaelsen mania scala (MAS) will also be recorded.

Data analysis: Data will be analysed in SPSS and presented descriptively in the two Groups to show whether the randomisation succeeded. A "intention to treat" analysis will be conducted, and on the basis of a requisite analysis a t-test, Mann-Whitney-Wilcoxon test or chi2-test will be used. The association between predictive factors and response to wake therapy will be described with prevalence proportions, ratios and will be analysed with a chi2-test. The level of statistical significance will be set at 5 %. The randomisation will be computer-generated, and the patients will be randomly allocated to the intervention group or the control group.

Sample size: The literature shows response rates at 41% after two weeks in the intervention group and 13 % in the control group. A power analysis based on these rates show that if α = 0,05 and β = 0,80, 37 patients should be included in each group, totally 74 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• wake therapy

Locations

Country	Name	City	State
Denmark	Mette Kragh	Risskov	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	Response is defined as a 50 % reduction or more compared to the baseline score in HAM-D 17.	Week two	No
Secondary	Remission	Remission will be defined as a score of <8 in HAM-D 17.	Week two	No
Secondary	Length of admission		Week nine	No
Secondary	Percentage of patients with response	Response is defined as a 50 % reduction or more compared to the baseline score in HAM-D 17.	week nine	No
Secondary	Percentage of patients with remission	Remission will be defined as a score of <8 in HAM-D 17.	week nine	No