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| Name | Class |
|---|---|
| Kowloon Hospital, Hong Kong | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I plus standard care | Experimental | The group CBT-I will receive both CBT-I and standard care. CBT-I covers sleep-wake cycle as well as sleep hygiene education, activity scheduling, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Standard care will include those treatments provided by the psychiatrists according to their clinical needs. |
|
| Standard care | No Intervention | Only standard care will be provided to this group. Medications will be prescribed and referral to community nurse, social worker and psychologist will be made by the doctors according to their need. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire | Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the severity of depression symptoms measured by 17-item Hamilton Depression Rating Scale (HAM-D17) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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) | 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) | 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) | 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) | 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) | 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) | 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) | Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline |
| The number and type of relapses | 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline |
| The number of clinic visits and hospitalizations | 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline |
| Change of subjects' perceived stress measured by Perceived Stress Scale | 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 | 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 | 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 | 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 | 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 | Baseline and immediate post-treatment, around 8-week post-baseline (CBT-I group), Baseline (Control group) |
| Prescribed medication burden | 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline |
| Subjects' satisfaction to CBT-I measured by treatment satisfaction scale | Immediate post-treatment (around 8-week post-baseline) |
| Subjects' adherence to CBT-I measured by treatment adherence scale | Immediate post-treatment (around 8-week post-baseline) |
| D001523 |
| Mental Disorders |