This study aims to investigate the effectiveness of transdiagnostic nurse-administered 4-session group cognitive behavioral therapy for insomnia (CBT-I) plus standard care, compared to standard care alone, for improving sleep and daytime function, enhancing recovery, preventing relapses, and reducing medication burden in patients with the first episode of mood disorders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants.
Queen Mary Hospital
Hong Kong, Hong Kong
Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of the severity of depression symptoms measured by 17-item Hamilton Depression Rating Scale (HAM-D17)
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of the severity of mania symptoms measured by Young Mania Rating Scale(YMRS)
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of the severity of illness measured by Clinical Global Impressions of Severity (CGI-S)
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of the anxiety and depression state measured by Hospital Anxiety and Depression Scale(HADS)
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' self-rated severity of physical symptoms measured by Somatic Symptom Inventory (SSI)
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
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Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' self-rated score of health state measured by 36-item Short Form Health Survey (SF-36)
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
The number and type of relapses
Time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
The number of clinic visits and hospitalizations
Time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' perceived stress measured by Perceived Stress Scale
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' sleep-incompatible beliefs and cognition measured by 16-item Dysfunctional Beliefs and Attitudes About Sleep Scale
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' cognitive and somatic arousal prior to sleep onset measured by Pre-sleep Arousal Scale
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' self-efficacy about sleep measured by Self-Efficacy for Sleep Scale
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' sleep inhibitory behavior measured by the Sleep Hygiene Practice Scale
Time frame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' credibility to treatment measured by Credibility of treatment rating scale
Time frame: Baseline and immediate post-treatment, around 8-week post-baseline (CBT-I group), Baseline (Control group)
Prescribed medication burden
Time frame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Subjects' satisfaction to CBT-I measured by treatment satisfaction scale
Time frame: Immediate post-treatment (around 8-week post-baseline)
Subjects' adherence to CBT-I measured by treatment adherence scale
Time frame: Immediate post-treatment (around 8-week post-baseline)