CBT-I as Early Intervention of Mood Disorders

The University of Hong Kong (HKU)

Status: Completed

Conditions: Insomnia Due to Mental Disorder

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT03000894

UW 16-057

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

CBT-I plus standard care

Experimental group

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Standard care

No Intervention group

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.