CBT-I as Early Intervention of Mood Disorders

NCT03000894 | Completed

• 1 other identifier: UW 16-057
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Due to Mental Disorder

Keywords

cognitive-behavioral therapy for insomnia; insomnia; mood disorder

Outcome Measures

Primary Outcomes (1)

• Chang of subjects'' self-rated score of severity of insomnia symptoms and functional impairment measured by Insomnia Severity Index (ISI) questionnaire

  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)

  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)

  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)

  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)

  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)

  Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline

Study Arms (2)

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.

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.

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) 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.

CBT-I plus standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Kowloon Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mood Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 22, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

HK (1)