Wake and Light Therapy to In-patients With Major Depression: Efficacy, Predictors and Patient Experiences
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): wake therapy
Intervention type(s): Behavioral
Other intervention name(s): light therapy; sleep time stabilisation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
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