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

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.