Clinical trial NCT03000894: CBT-I as Early Intervention of Mood Disorders
Official title: Cognitive Behavioral Therapy for Insomnia as a Transdiagnostic Early Intervention of Mood Disorders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Due to Mental Disorder
Keywords: cognitive-behavioral therapy for insomnia
insomnia
mood disorder
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Kowloon Hospital, Hong Kong
First posted: 2016-12-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Hong Kong residents
* Aged ≥ 18 years
* Able to to communicate in Cantonese and write in Chinese
* First episode of depressive or bipolar disorders according to the DSM-5 diagnostic criteria
* Having received psychiatric treatment for less than 12 months
* Meeting the DSM-5 diagnostic criteria for insomnia disorder for at least 1 month, instead of at least 3 months, as in criterion D.

Exclusion Criteria:

* Significant cognitive impairments and psychotic symptoms, based on a Mini-mental State Examination score of 23 or below and the Positive and Negative Syndrome Scale items on delusions, conceptual disorganization, and hallucinatory behavior at moderate severity or above
* A diagnosis of schizophrenia, delusional disorder, neurocognitive disorders, or learning disability
* Having a highly unstable medical or psychiatric condition (including strong suicidal risk) that requires hospitalization
* Having an untreated sleep disorder, including narcolepsy, obstructive sleep apnea, and periodic leg movement disorder
* Past or current treatment with CBT-I
* Having a fear of speaking in a group setting or refusal to give informed consent
* Refuse to give informed consent

Primary outcomes:
measure: Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary outcomes:
measure: Change of the severity of depression symptoms measured by 17-item Hamilton Depression Rating Scale (HAM-D17)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of the severity of mania symptoms measured by Young Mania Rating Scale(YMRS)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of the severity of illness measured by Clinical Global Impressions of Severity (CGI-S)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of the anxiety and depression state measured by Hospital Anxiety and Depression Scale(HADS)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' self-rated severity of physical symptoms measured by Somatic Symptom Inventory (SSI)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' self-rated score of health state measured by 36-item Short Form Health Survey (SF-36)
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: The number and type of relapses
timeFrame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: The number of clinic visits and hospitalizations
timeFrame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' perceived stress measured by Perceived Stress Scale
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' sleep-incompatible beliefs and cognition measured by 16-item Dysfunctional Beliefs and Attitudes About Sleep Scale
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' cognitive and somatic arousal prior to sleep onset measured by Pre-sleep Arousal Scale
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' self-efficacy about sleep measured by Self-Efficacy for Sleep Scale
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' sleep inhibitory behavior measured by the Sleep Hygiene Practice Scale
timeFrame: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Change of subjects' credibility to treatment measured by Credibility of treatment rating scale
timeFrame: Baseline and immediate post-treatment, around 8-week post-baseline (CBT-I group), Baseline (Control group)
measure: Prescribed medication burden
timeFrame: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
measure: Subjects' satisfaction to CBT-I measured by treatment satisfaction scale
timeFrame: Immediate post-treatment (around 8-week post-baseline)
measure: Subjects' adherence to CBT-I measured by treatment adherence scale
timeFrame: Immediate post-treatment (around 8-week post-baseline)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References: