CBT-I as Early Intervention of Mood Disorders

NCT ID: NCT03000894

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia Due to Mental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kowloon Hospital, Hong Kong

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Chung Ka-Fai

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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UW 16-057

Identifier Type: -

Identifier Source: org_study_id

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