A randomized placebo-controlled trial of adjunctive non-pharmacological treatment in patients with bipolar depression and eveningness
Bipolar affective disorder (BD) causes significant personal distress, socioeconomic burden, frequent hospitalization, caring burden and suicidality, and is difficult to treat as it is more predominant by depressive phases. Sleep-wake cycle is a core manifestation of the endogenous circadian rhythm. Circadian disruption appears to be more conspicuous in bipolar disorder. In our previous investigation, bipolar patients were at a higher risk for delayed sleep phase disorder and insomnia disorder. Evening-chronotype is significantly associated with bipolar depression, and such patients are at a higher risk of adverse outcomes and suboptimal response to treatment.
We aim to evaluate the efficacy of two non-pharmacological treatments in reducing depressive symptoms and insomnia symptoms at the treatment endpoint (a 6-week treatment), by conducting a randomized placebo-controlled trial. We also hope to explore the changes in urinary aMT6 secretion and pupil response before and after treatment.
We aim to recruit adults aged 18-65 with bipolar depression who is receiving treatment from the psychiatric specialist out-patient clinics in the Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital.
- Clinical Interviews,
- Questionnaires,
- Sleep Diary,
- Non-pharmacological treatment,
- Urine samples collection,
- Actiwatch,
- Pupillometry
Subjects will be randomized to receive six-weeks of non-pharmacological treatment targeting depression (either light therapy or negative ion therapy). The treatment will be conducted at home for 30-minutes a day. Follow-up visits will be conducted at baseline, 2nd, 4th, and 6th week. Each participant will receive up to HKD$1200 as travel allowance if they completed all study visits.
