Back to resultsCBT-I as Early Intervention of Mood Disorders
Primary Purpose
Insomnia Due to Mental Disorder
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia Due to Mental Disorder focused on measuring cognitive-behavioral therapy for insomnia, insomnia, mood disorder
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
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CBT-I plus standard care
Standard care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire
Secondary Outcome Measures
Change of the severity of depression symptoms measured by 17-item Hamilton Depression Rating Scale (HAM-D17)
Change of the severity of mania symptoms measured by Young Mania Rating Scale(YMRS)
Change of the severity of illness measured by Clinical Global Impressions of Severity (CGI-S)
Change of the anxiety and depression state measured by Hospital Anxiety and Depression Scale(HADS)
Change of subjects' self-rated severity of physical symptoms measured by Somatic Symptom Inventory (SSI)
Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)
Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)
Change of subjects' self-rated score of health state measured by 36-item Short Form Health Survey (SF-36)
The number and type of relapses
The number of clinic visits and hospitalizations
Change of subjects' perceived stress measured by Perceived Stress Scale
Change of subjects' sleep-incompatible beliefs and cognition measured by 16-item Dysfunctional Beliefs and Attitudes About Sleep Scale
Change of subjects' cognitive and somatic arousal prior to sleep onset measured by Pre-sleep Arousal Scale
Change of subjects' self-efficacy about sleep measured by Self-Efficacy for Sleep Scale
Change of subjects' sleep inhibitory behavior measured by the Sleep Hygiene Practice Scale
Change of subjects' credibility to treatment measured by Credibility of treatment rating scale
Prescribed medication burden
Subjects' satisfaction to CBT-I measured by treatment satisfaction scale
Subjects' adherence to CBT-I measured by treatment adherence scale
Full Information
NCT ID
NCT03000894
First Posted
December 12, 2016
Last Updated
March 23, 2020
Sponsor
The University of Hong Kong
Collaborators
Kowloon Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03000894
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Kowloon Hospital, Hong Kong
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Due to Mental Disorder
Keywords
cognitive-behavioral therapy for insomnia, insomnia, mood disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-I plus standard care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)
Time Frame
Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Title
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
Title
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
Title
The number and type of relapses
Time Frame
3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Title
The number of clinic visits and hospitalizations
Time Frame
3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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)
Title
Prescribed medication burden
Time Frame
3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Title
Subjects' satisfaction to CBT-I measured by treatment satisfaction scale
Time Frame
Immediate post-treatment (around 8-week post-baseline)
Title
Subjects' adherence to CBT-I measured by treatment adherence scale
Time Frame
Immediate post-treatment (around 8-week post-baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
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CBT-I as Early Intervention of Mood Disorders
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