Insomnia Due to Mental DisorderNCT03000894
CBT-I as Early Intervention of Mood Disorders
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Insomnia Due to Mental Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Due to Mental Disorder
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2017to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavioral Therapy for Insomnia as a Transdiagnostic Early Intervention of Mood Disorders: A Randomized Controlled Trial
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.
- Conditions
- Insomnia Due to Mental Disorder
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- Keywords
- cognitive-behavioral therapy for insomnia, insomnia, mood disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire
Measured: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary outcomes (20)
Change of the severity of depression symptoms measured by 17-item Hamilton Depression Rating Scale (HAM-D17)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
The number and type of relapses
Measured: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
The number of clinic visits and hospitalizations
Measured: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Change of subjects' perceived stress measured by Perceived Stress Scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and immediate post-treatment, around 8-week post-baseline (CBT-I group), Baseline (Control group)
Prescribed medication burden
Measured: 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Subjects' satisfaction to CBT-I measured by treatment satisfaction scale
Measured: Immediate post-treatment (around 8-week post-baseline)
Subjects' adherence to CBT-I measured by treatment adherence scale
Measured: Immediate post-treatment (around 8-week post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Due to Mental DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Kowloon Hospital, Hong Kong
- Responsible party
- Principal investigator, Dr. Chung Ka-Fai, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000894
- Sponsor's protocol ID
- UW 16-057
- Status last verified
- Mar 2020
- First submitted
- 12 Dec 2016
- Last updated
- 25 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia as a Transdiagnostic Early Intervention of Mood Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03000894
- Acronym / sponsor ID
- UW 16-057
- Conditions
- Insomnia Due to Mental Disorder
- Keywords
- cognitive-behavioral therapy for insomnia, insomnia, mood disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Kowloon Hospital, Hong Kong
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I plus standard care | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I)This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants. | Behavioural | CBT-I plus standard care |
Primary outcome
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
20 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) in people with Insomnia Due to Mental Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.