CBT-I as Early Intervention of Mood Disorders

Insomnia Due to Mental Disorder Clinical Trial

Official title:

Cognitive Behavioral Therapy for Insomnia as a Transdiagnostic Early Intervention of Mood Disorders: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000894
• Other study ID #: UW 16-057
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 in patients with the first episode of mood disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Insomnia Due to Mental Disorder
• Mental Disorders
• Mood Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Kowloon Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of subjects' likeliness of dozing measured by Epworth Sleepiness Scale (ESS)		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' self-rated fatigue score measured by Multidimensional Fatigue Inventory (MFI)		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' functioning regarding work/study, social life and family measured by Sheehan Disability Scale (SDS)		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' self-rated score of health state measured by 36-item Short Form Health Survey (SF-36)		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	The number and type of relapses		3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	The number of clinic visits and hospitalizations		3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' perceived stress measured by Perceived Stress Scale		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' sleep-incompatible beliefs and cognition measured by 16-item Dysfunctional Beliefs and Attitudes About Sleep Scale		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' cognitive and somatic arousal prior to sleep onset measured by Pre-sleep Arousal Scale		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' self-efficacy about sleep measured by Self-Efficacy for Sleep Scale		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' sleep inhibitory behavior measured by the Sleep Hygiene Practice Scale		Baseline, 3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Change of subjects' credibility to treatment measured by Credibility of treatment rating scale		Baseline and immediate post-treatment, around 8-week post-baseline (CBT-I group), Baseline (Control group)
Secondary	Prescribed medication burden		3-month post-baseline, 6-month post-baseline, and 12-month post-baseline
Secondary	Subjects' satisfaction to CBT-I measured by treatment satisfaction scale		Immediate post-treatment (around 8-week post-baseline)
Secondary	Subjects' adherence to CBT-I measured by treatment adherence scale		Immediate post-treatment (around 8-week post-baseline)