Cognitive Behavioral Therapy for Insomnia as a Transdiagnostic Early Intervention of Mood Disorders: A Randomized Controlled Trial

Background: Insomnia is a common complaint often associated with significant distress, functional impairment, and socio-economic cost. There is robust evidence that insomnia is implicated in the onset, presentation, and prognosis of a wide range of psychiatric disorders, including mood disorders. Patients are often left with residual insomnia despite an adequate course of pharmacological or psychological treatment. Among various psycho-behavioral interventions, cognitive behavioral therapy for insomnia (CBT-I) has the strongest evidence base to suggest that it is safe, efficacious, and durable. Proposed as a transdiagnostic treatment, manualized CBT-I can be administered by healthcare professionals after receiving training and used as an early intervention for mood disorders. Aims: To investigate the effectiveness of nurse-administered 4-session group CBT-I, compared to standard care, for improving sleep and daytime function, enhancing recovery, preventing relapses, and reducing medication burden in patients with the first episode of major depression, mania, or hypomania. Methods: This will be a prospective, randomized, assessor-blind controlled trial. Two hundred subjects, stratified by psychiatric diagnosis of major depression or mania/hypomania, will be randomly assigned to 4 sessions of 60-90 minutes group CBT-I over 8 weeks or standard care in a 1:1 ratio. The CBT-I sessions will cover sleep education, relaxation training, stimulus control therapy, sleep restriction, and cognitive therapy. Patients with the first episode of major depression, mania, or hypomania and comorbid insomnia in addition to having received psychiatric treatment for less than 12 months will be recruited from regional psychiatric clinics. Other than participation in the group CBT-I, patients will be treated by their psychiatrists according to clinical needs. Patients will be assessed 4 times in total at baseline and 3, 6, and 12-month post-baseline. Insomnia Severity Index will be the primary outcome measure. Secondary outcomes include depressive, manic, anxiety, and somatic symptoms, daytime sleepiness, fatigue, functioning, quality of life, medication burden, number and type of relapses, and number of clinic visits and hospitalizations. Data analysis: The difference between intervention and standard care will be assessed using mixed-effects group-by-time interaction or chi-square test. Significance: This will be the first study on the effectiveness of 4-session group CBT-I for early intervention of psychiatric disorders. Nurse-administered 4-session group CBT-I, if proven effective in mood disorders, can be applied as an early intervention in other psychiatric disorders that are commonly associated with insomnia.

Funding Source: RGC - General Research Fund (GRF)