CBT-I as Early Intervention of Mood Disorders

March 23, 2020 updated by: Dr. Chung Ka-Fai, The University of Hong Kong

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBT-I plus standard care
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.
Behavioral: 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.
No Intervention: Standard care
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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)
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)
Immediate post-treatment (around 8-week post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kowloon Hospital, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UW 16-057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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